<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03756571</url>
  </required_header>
  <id_info>
    <org_study_id>R21HD094823</org_study_id>
    <nct_id>NCT03756571</nct_id>
  </id_info>
  <brief_title>Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations</brief_title>
  <acronym>CP-AFOFC</acronym>
  <official_title>Biomechanics and Walking in Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orthocare Innovations</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hanger Clinic: Prosthetics &amp; Orthotics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cascade DAFO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical&#xD;
      alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and&#xD;
      experience walking activity limitations that negatively influence their ability to&#xD;
      participate in day to day life. Ankle Foot Orthoses (AFO) are a fundamental rehabilitation&#xD;
      strategy to facilitate walking in children with CP; yet, a review suggests that efficacy of&#xD;
      the &quot;traditional&quot; solid AFO (TSAFO) in this population remains equivocal. A novel decision&#xD;
      tree to guide orthotic prescription proposes a patient-specific method for adjusting AFO&#xD;
      alignment and integrating footwear modifications (Ankle Foot Orthoses-Footwear Combinations,&#xD;
      AFO-FC). This approach is based on visualizing the sagittal plane orientation of the ground&#xD;
      reaction force vector with respect to lower limb segments during gait. The AFO-FC represents&#xD;
      a paradigm shift in orthotic management as it accommodates ankle equinus contractures in a&#xD;
      rigid AFO, reorients the tibial segment with a heel wedge under the AFO, and applies&#xD;
      different heel, midsole and forefoot shoe modifications to restore lost ankle-foot rockers.&#xD;
      The primary goal of AFO-FCs are to improve stability by facilitating more normal segment&#xD;
      kinematics in single limb stance, decreasing hip/knee flexion. Despite their promise,&#xD;
      evidence of an immediate positive effect on midstance alignment is limited, with no evidence&#xD;
      of clinical effectiveness.&#xD;
&#xD;
      This proposal assesses the feasibility of using a randomized waitlist study to acquire pilot&#xD;
      data on a targeted clinical cohort of children with CP evaluating the effectiveness of&#xD;
      AFO-FCs as compared to TSAFO during daily life. Individual joint and combined kinematics and&#xD;
      kinetics will be examined for potential mechanisms of action as well as daily walking&#xD;
      performance, balance and satisfaction with the AFO-FC in 30 ambulatory children with CP, ages&#xD;
      4-9 years, with bilateral crouch or equinus gait pattern, comparing gait in TSAFO to the&#xD;
      AFO-FCs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this proposal is to assess the feasibility of using a randomized waitlist study&#xD;
      to acquire pilot data on a targeted clinical cohort of children with CP evaluating the&#xD;
      effectiveness of AFO-FCs as compared to TSAFO during daily life. Individual joint and&#xD;
      combined kinematics and kinetics will be examined for potential mechanisms of action as well&#xD;
      as daily walking performance, balance and satisfaction with the AFO-FC in 30 ambulatory&#xD;
      children with spastic diplegia CP, ages 4-9 years, with bilateral crouch or equinus gait&#xD;
      pattern, comparing gait in TSAFO to the AFO-FCs.&#xD;
&#xD;
      Aim 1: Examine the effect of AFO-FC on individual joint kinematics, overall gait deviations&#xD;
      and walking speed as compared to the TSAFO in children with CP. Multiple gait deviations&#xD;
      (e.g. crouch or equinus) in CP result in slow, inefficient walking [14]. We hypothesize that&#xD;
      the individualized ankle angle, leg segment alignment, and footwear profiles of the AFO-FCs&#xD;
      will optimize lower limb joint kinematics, decrease overall gait deviations facilitating&#xD;
      longer step lengths (improved stance stability), with resultant increased gait speed as&#xD;
      compared to TSAFO. Instrumented gait analysis will assess gait speed and calculate changes in&#xD;
      joint specific kinematics with the Gait Profile Score (GPS) and overall combined gait&#xD;
      kinematics with the GDI.&#xD;
&#xD;
      Aim 2: Examine the effect of AFO-FC on daily walking activity, balance, mobility, and&#xD;
      satisfaction as compared to the TSAFO in children with CP. We hypothesize that the AFO-FC&#xD;
      will positively affect community walking activity levels, balance, physical activity and&#xD;
      satisfaction as compared to the TSAFO. Walking activity will be captured by the StepWatch ®&#xD;
      accelerometer; balance by the Pediatric Balance Scale; physical activity by the Patient&#xD;
      Reported Outcomes Measurement System (PROMIS®) Pediatric Physical Activity and the Gait&#xD;
      Outcomes Assessment List (GOAL); and satisfaction with device by the Orthotic and Prosthetic&#xD;
      Users' Survey (OPUS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Study Design and Randomization. A randomized waitlist trial will be used to compare the AFO-FC to TSAFO in ambulatory children with CP.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Primary outcomes are Gait Profile Score (GPS), Gait Deviation Index (GDI), gait speed from three dimensional gait analysis and community walking activity are all collected via technology (three dimensional gait lab, accelerometry, thus masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>The Gait Profile Score (GPS) represents the pattern of deviation as a single number and is derived from the same individual joint/limb gait kinematics as Gait Deviation Index (GDI) The GPS minimum value is 0 and maximum value is 20. A higher score is a worse outcome. An minimally clinically important difference is published to be 1.6 for children with CP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Right Baseline Gait Deviation Index (GDI) at 3 Months</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side left/right. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score &gt; 100 is considered in the normal range. A higher score is a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months.</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>Gait speed will be captured during the three dimensional gait analysis testing. Gait speed is measured in meters per second (m/sec) with range from 0 to ~ 3.0 m/sec for walking in children. A higher number of m/sec is considered a better outcome with minimally clinically important difference (MCID) of .10 m/s for persons with CP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day.</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>Community walking activity will be captured by the ankle worn StepWatch ® accelerometer capturing change in average strides/day. The StepWatch ® is a two dimension accelerometer validated to capture when the foot leaves the ground for a metric of stride counts within the context of daily life. Average strides/day can range from 0 to unlimited strides/day. A higher number of strides/day is considered a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of &gt; 60 Strides/Minute.</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>Community walking activity will be captured by the ankle worn StepWatch Accelerometer capturing % time at high stride rates. Percent time at high stride rates (&gt; 60 strides/min) can range from 0 to 100% with a higher percent considered a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Left Baseline Gait Deviation Index (GDI) at 3 Months</measure>
    <time_frame>Change in Right baseline Gait Deviation Index (GDI) at 3 months</time_frame>
    <description>Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side LEFT/RIGHT. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score &gt; 100 is considered in the 'normal' range. A higher score is a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale.</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>The Pediatric Balance Scale (PBS) is a functional measure intended to assess balance in a clinical setting for children with neurological impairment. The PBS is a scaled scoring with range of 0 to 100 with a higher score a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score .</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>Gait Outcomes Assessment List (GOAL) - The Gait Outcomes Assessment List (GOAL) is a outcome assessment to evaluate gait priorities and functional mobility for ambulant children with CP. The GOAL range of standard scores is 0 to 100 with a high score a better outcome. The GOAL will allow clinicians to better understand the motor abilities, priorities, and expectations of ambulant children with CP and to improve decision-making about appropriate interventions. The GOAL consists of 48 items grouped into seven domains: 1) activities of daily living and independence; 2) gait function and mobility; 3) pain, discomfort and fatigue; 4) physical activities, sports and recreation; 5) gait pattern and appearance; 6) use of braces and mobility aids; and 7) body image and self-esteem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes.</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>Parental report of Physical Function Mobility subscale T-scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric survey. The PROMIS Physical Function subscale T score range is 0 to 100 with a higher score a better outcome. The mean of the T-score for Physical Function Mobility is 50 with a SD of 10, For parental report a score &gt; or equal to 45 is consider Good, 36 - 44 Fair and &lt; or equal to 35 Poor physical Function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>Parental report of pain/fatigue domain standard scores on the Gait Outcomes Assessment List (GOAL). The range of the pain/fatigue subscale of the GOAL 0 to 100. A higher score is a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>Parental report of selected pain and pain interference items from the Patient-Reported Outcomes Measurement Information System (PROMIS)pediatric survey. The Pediatric PROMIS pain interference subscale T score range is 0 to 100 with a lower score a better outcome. The mean is 50 with SD of 10. For the Pain interference a T score &lt; 50 is considered within normal limits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference Between Groups in Satisfaction With Orthoses/Shoes After Wearing for 3 Months Per Orthotic and Prosthetic Users Survey (OPUS).</measure>
    <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
    <description>Parental report of satisfaction raw score items from the Orthotic and Prosthetic Users' Survey (OPUS). The range of OPUS scores is 11-55 with a higher score a better outcome. The raw scores are employed as the survey validation for Rasch scores is not completed for children.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Cerebral Palsy (CP)</condition>
  <arm_group>
    <arm_group_label>Ankle Foot Orthoses-Footwear Combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Solid Ankle AFO (TSAFO)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ankle Foot Orthoses-Footwear Combination</intervention_name>
    <description>This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
    <arm_group_label>Ankle Foot Orthoses-Footwear Combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional Solid Ankle AFO (TSAFO)</intervention_name>
    <description>This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
    <arm_group_label>Traditional Solid Ankle AFO (TSAFO)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ambulatory children with spastic diplegia CP,&#xD;
&#xD;
          -  spasticity primary movement disorder&#xD;
&#xD;
          -  aged 4-9 years&#xD;
&#xD;
          -  Gross Motor Function Classification System (GMFCS) levels of II or III&#xD;
&#xD;
          -  clinically appropriate for a solid AFO based on physical exam/visual gait analysis&#xD;
             criteria of:&#xD;
&#xD;
               1. insufficient gastrocnemius length to allow knee extension with ankle dorsiflexion&#xD;
                  of 10 degrees and an uncompromised foot arch;&#xD;
&#xD;
               2. low tone in the calf muscles with inability to control dorsiflexion during&#xD;
                  stance;&#xD;
&#xD;
               3. insufficient calf muscle strength to prevent excessive dorsiflexion in stance and&#xD;
                  create a 'quasi stiff&quot; ankle in terminal stance that allows the heel to rise from&#xD;
                  the ground; and&#xD;
&#xD;
               4. insufficient triplanar boney stability of the foot during stance phase&#xD;
                  dorsiflexion&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have undergone:&#xD;
&#xD;
        orthopedic or neurological surgery less than 6 months prior to enrollment or injection&#xD;
        therapies (phenol, botulinum toxin) less than 3 months prior to enrollment will be&#xD;
        excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristie F Bjornson, PhD, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seattle Children's Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 5, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>June 16, 2021</results_first_submitted>
  <results_first_submitted_qc>August 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2021</results_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Kristie Bjornson</investigator_full_name>
    <investigator_title>Associate Professor, Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03756571/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03756571/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All participants were approached and recruited through clinical care at Seattle Children's Hospital (SCH) or regionally by study team, once clinically deemed to meet inclusion criteria.</recruitment_details>
      <pre_assignment_details>This was a randomized cross over design where those who randomized to TSAFO group first then crossed over without a washout period to the AFOFC treatment arm after 3 months of wearing the TSAFO.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ankle Foot Orthoses-Footwear Combination</title>
          <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
        </group>
        <group group_id="P2">
          <title>Traditional Solid Ankle AFO (TSAFO)</title>
          <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>These are the individual children who randomized to the two comparison conditions.</population>
      <group_list>
        <group group_id="B1">
          <title>Ankle Foot Orthoses-Footwear Combination</title>
          <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
        </group>
        <group group_id="B2">
          <title>Traditional Solid Ankle AFO (TSAFO)</title>
          <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.3" lower_limit="5.1" upper_limit="9.6"/>
                    <measurement group_id="B2" value="6.6" lower_limit="4.2" upper_limit="9.8"/>
                    <measurement group_id="B3" value="6.9" lower_limit="4.2" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics</title>
        <description>The Gait Profile Score (GPS) represents the pattern of deviation as a single number and is derived from the same individual joint/limb gait kinematics as Gait Deviation Index (GDI) The GPS minimum value is 0 and maximum value is 20. A higher score is a worse outcome. An minimally clinically important difference is published to be 1.6 for children with CP.</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics</title>
          <description>The Gait Profile Score (GPS) represents the pattern of deviation as a single number and is derived from the same individual joint/limb gait kinematics as Gait Deviation Index (GDI) The GPS minimum value is 0 and maximum value is 20. A higher score is a worse outcome. An minimally clinically important difference is published to be 1.6 for children with CP.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="1.95"/>
                    <measurement group_id="O2" value="-0.48" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.36</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Right Baseline Gait Deviation Index (GDI) at 3 Months</title>
        <description>Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side left/right. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score &gt; 100 is considered in the normal range. A higher score is a better outcome.</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Right Baseline Gait Deviation Index (GDI) at 3 Months</title>
          <description>Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side left/right. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score &gt; 100 is considered in the normal range. A higher score is a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".07" spread="10.2"/>
                    <measurement group_id="O2" value="3.2" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.50</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months.</title>
        <description>Gait speed will be captured during the three dimensional gait analysis testing. Gait speed is measured in meters per second (m/sec) with range from 0 to ~ 3.0 m/sec for walking in children. A higher number of m/sec is considered a better outcome with minimally clinically important difference (MCID) of .10 m/s for persons with CP.</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months.</title>
          <description>Gait speed will be captured during the three dimensional gait analysis testing. Gait speed is measured in meters per second (m/sec) with range from 0 to ~ 3.0 m/sec for walking in children. A higher number of m/sec is considered a better outcome with minimally clinically important difference (MCID) of .10 m/s for persons with CP.</description>
          <units>meters/second (m/s)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.03" spread="18"/>
                    <measurement group_id="O2" value=".13" spread=".16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.15</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day.</title>
        <description>Community walking activity will be captured by the ankle worn StepWatch ® accelerometer capturing change in average strides/day. The StepWatch ® is a two dimension accelerometer validated to capture when the foot leaves the ground for a metric of stride counts within the context of daily life. Average strides/day can range from 0 to unlimited strides/day. A higher number of strides/day is considered a better outcome.</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day.</title>
          <description>Community walking activity will be captured by the ankle worn StepWatch ® accelerometer capturing change in average strides/day. The StepWatch ® is a two dimension accelerometer validated to capture when the foot leaves the ground for a metric of stride counts within the context of daily life. Average strides/day can range from 0 to unlimited strides/day. A higher number of strides/day is considered a better outcome.</description>
          <units>strides/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-804" spread="1131"/>
                    <measurement group_id="O2" value="-182" spread="813"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.23</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of &gt; 60 Strides/Minute.</title>
        <description>Community walking activity will be captured by the ankle worn StepWatch Accelerometer capturing % time at high stride rates. Percent time at high stride rates (&gt; 60 strides/min) can range from 0 to 100% with a higher percent considered a better outcome.</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of &gt; 60 Strides/Minute.</title>
          <description>Community walking activity will be captured by the ankle worn StepWatch Accelerometer capturing % time at high stride rates. Percent time at high stride rates (&gt; 60 strides/min) can range from 0 to 100% with a higher percent considered a better outcome.</description>
          <units>percentage of time in &gt; 60 strides/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.03" spread="0.24"/>
                    <measurement group_id="O2" value="-.15" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.70</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Left Baseline Gait Deviation Index (GDI) at 3 Months</title>
        <description>Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side LEFT/RIGHT. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score &gt; 100 is considered in the 'normal' range. A higher score is a better outcome.</description>
        <time_frame>Change in Right baseline Gait Deviation Index (GDI) at 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Left Baseline Gait Deviation Index (GDI) at 3 Months</title>
          <description>Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side LEFT/RIGHT. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score &gt; 100 is considered in the 'normal' range. A higher score is a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="2.7"/>
                    <measurement group_id="O2" value="1.3" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.33</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale.</title>
        <description>The Pediatric Balance Scale (PBS) is a functional measure intended to assess balance in a clinical setting for children with neurological impairment. The PBS is a scaled scoring with range of 0 to 100 with a higher score a better outcome.</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale.</title>
          <description>The Pediatric Balance Scale (PBS) is a functional measure intended to assess balance in a clinical setting for children with neurological impairment. The PBS is a scaled scoring with range of 0 to 100 with a higher score a better outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="10.5"/>
                    <measurement group_id="O2" value="3.5" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score .</title>
        <description>Gait Outcomes Assessment List (GOAL) - The Gait Outcomes Assessment List (GOAL) is a outcome assessment to evaluate gait priorities and functional mobility for ambulant children with CP. The GOAL range of standard scores is 0 to 100 with a high score a better outcome. The GOAL will allow clinicians to better understand the motor abilities, priorities, and expectations of ambulant children with CP and to improve decision-making about appropriate interventions. The GOAL consists of 48 items grouped into seven domains: 1) activities of daily living and independence; 2) gait function and mobility; 3) pain, discomfort and fatigue; 4) physical activities, sports and recreation; 5) gait pattern and appearance; 6) use of braces and mobility aids; and 7) body image and self-esteem.</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score .</title>
          <description>Gait Outcomes Assessment List (GOAL) - The Gait Outcomes Assessment List (GOAL) is a outcome assessment to evaluate gait priorities and functional mobility for ambulant children with CP. The GOAL range of standard scores is 0 to 100 with a high score a better outcome. The GOAL will allow clinicians to better understand the motor abilities, priorities, and expectations of ambulant children with CP and to improve decision-making about appropriate interventions. The GOAL consists of 48 items grouped into seven domains: 1) activities of daily living and independence; 2) gait function and mobility; 3) pain, discomfort and fatigue; 4) physical activities, sports and recreation; 5) gait pattern and appearance; 6) use of braces and mobility aids; and 7) body image and self-esteem.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.91" spread="9.2"/>
                    <measurement group_id="O2" value="-0.44" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes.</title>
        <description>Parental report of Physical Function Mobility subscale T-scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric survey. The PROMIS Physical Function subscale T score range is 0 to 100 with a higher score a better outcome. The mean of the T-score for Physical Function Mobility is 50 with a SD of 10, For parental report a score &gt; or equal to 45 is consider Good, 36 - 44 Fair and &lt; or equal to 35 Poor physical Function</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes.</title>
          <description>Parental report of Physical Function Mobility subscale T-scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric survey. The PROMIS Physical Function subscale T score range is 0 to 100 with a higher score a better outcome. The mean of the T-score for Physical Function Mobility is 50 with a SD of 10, For parental report a score &gt; or equal to 45 is consider Good, 36 - 44 Fair and &lt; or equal to 35 Poor physical Function</description>
          <units>T score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2" spread="3.8"/>
                    <measurement group_id="O2" value="32.9" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.08</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months</title>
        <description>Parental report of pain/fatigue domain standard scores on the Gait Outcomes Assessment List (GOAL). The range of the pain/fatigue subscale of the GOAL 0 to 100. A higher score is a better outcome.</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months</title>
          <description>Parental report of pain/fatigue domain standard scores on the Gait Outcomes Assessment List (GOAL). The range of the pain/fatigue subscale of the GOAL 0 to 100. A higher score is a better outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.3" spread="12.2"/>
                    <measurement group_id="O2" value="78.2" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.18</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey</title>
        <description>Parental report of selected pain and pain interference items from the Patient-Reported Outcomes Measurement Information System (PROMIS)pediatric survey. The Pediatric PROMIS pain interference subscale T score range is 0 to 100 with a lower score a better outcome. The mean is 50 with SD of 10. For the Pain interference a T score &lt; 50 is considered within normal limits.</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey</title>
          <description>Parental report of selected pain and pain interference items from the Patient-Reported Outcomes Measurement Information System (PROMIS)pediatric survey. The Pediatric PROMIS pain interference subscale T score range is 0 to 100 with a lower score a better outcome. The mean is 50 with SD of 10. For the Pain interference a T score &lt; 50 is considered within normal limits.</description>
          <units>T score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.6" spread="8.6"/>
                    <measurement group_id="O2" value="53.4" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.15</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference Between Groups in Satisfaction With Orthoses/Shoes After Wearing for 3 Months Per Orthotic and Prosthetic Users Survey (OPUS).</title>
        <description>Parental report of satisfaction raw score items from the Orthotic and Prosthetic Users' Survey (OPUS). The range of OPUS scores is 11-55 with a higher score a better outcome. The raw scores are employed as the survey validation for Rasch scores is not completed for children.</description>
        <time_frame>3 months post wearing assigned orthotic intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ankle Foot Orthoses-Footwear Combination</title>
            <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
          </group>
          <group group_id="O2">
            <title>Traditional Solid Ankle AFO (TSAFO)</title>
            <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between Groups in Satisfaction With Orthoses/Shoes After Wearing for 3 Months Per Orthotic and Prosthetic Users Survey (OPUS).</title>
          <description>Parental report of satisfaction raw score items from the Orthotic and Prosthetic Users' Survey (OPUS). The range of OPUS scores is 11-55 with a higher score a better outcome. The raw scores are employed as the survey validation for Rasch scores is not completed for children.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1" spread="6.9"/>
                    <measurement group_id="O2" value="42.8" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.80</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from baseline consent visit through 3 month follow-up of initial randomized phase of trial and through the second cross over phase to the AFOFC condition.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ankle Foot Orthoses-Footwear Combination</title>
          <description>The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.&#xD;
Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.</description>
        </group>
        <group group_id="E2">
          <title>Traditional Solid Ankle AFO (TSAFO)</title>
          <description>The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the &quot;traditional&quot; SAFO (TSAFO)...&#xD;
Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Mild</sub_title>
                <description>inconvenience to day to day life (i.e. skin redness with device wear that lasts &gt; 30 min post removal)</description>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Moderate</sub_title>
                <description>required medical attention (i.e. Orthotist modified the device to address a blister resulting from wear of device)</description>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="10" subjects_affected="6" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to hardware failure in Dec 2020, there was a data loss of the gait outcomes at the OrthoCare Biomechanics Lab (gait lab). Thus the gait lab variables of GPS and GDI have a sample size of 13, where all other outcomes have a sample size of 19.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kristie Bjornson, PT, PhD</name_or_title>
      <organization>Seattle Children's Research Institute</organization>
      <phone>206-884-2066</phone>
      <email>Kristie.bjornson@seattlechildrens.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03756571
org study id: R21HD094823
nct id: NCT03756571
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical
      alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and
      experience walking activity limitations that negatively influence their ability to
      participate in day to day life. Ankle Foot Orthoses (AFO) are a fundamental rehabilitation
      strategy to facilitate walking in children with CP; yet, a review suggests that efficacy of
      the "traditional" solid AFO (TSAFO) in this population remains equivocal. A novel decision
      tree to guide orthotic prescription proposes a patient-specific method for adjusting AFO
      alignment and integrating footwear modifications (Ankle Foot Orthoses-Footwear Combinations,
      AFO-FC). This approach is based on visualizing the sagittal plane orientation of the ground
      reaction force vector with respect to lower limb segments during gait. The AFO-FC represents
      a paradigm shift in orthotic management as it accommodates ankle equinus contractures in a
      rigid AFO, reorients the tibial segment with a heel wedge under the AFO, and applies
      different heel, midsole and forefoot shoe modifications to restore lost ankle-foot rockers.
      The primary goal of AFO-FCs are to improve stability by facilitating more normal segment
      kinematics in single limb stance, decreasing hip/knee flexion. Despite their promise,
      evidence of an immediate positive effect on midstance alignment is limited, with no evidence
      of clinical effectiveness.

      This proposal assesses the feasibility of using a randomized waitlist study to acquire pilot
      data on a targeted clinical cohort of children with CP evaluating the effectiveness of
      AFO-FCs as compared to TSAFO during daily life. Individual joint and combined kinematics and
      kinetics will be examined for potential mechanisms of action as well as daily walking
      performance, balance and satisfaction with the AFO-FC in 30 ambulatory children with CP, ages
      4-9 years, with bilateral crouch or equinus gait pattern, comparing gait in TSAFO to the
      AFO-FCs.
The goal of this proposal is to assess the feasibility of using a randomized waitlist study
      to acquire pilot data on a targeted clinical cohort of children with CP evaluating the
      effectiveness of AFO-FCs as compared to TSAFO during daily life. Individual joint and
      combined kinematics and kinetics will be examined for potential mechanisms of action as well
      as daily walking performance, balance and satisfaction with the AFO-FC in 30 ambulatory
      children with spastic diplegia CP, ages 4-9 years, with bilateral crouch or equinus gait
      pattern, comparing gait in TSAFO to the AFO-FCs.

      Aim 1: Examine the effect of AFO-FC on individual joint kinematics, overall gait deviations
      and walking speed as compared to the TSAFO in children with CP. Multiple gait deviations
      (e.g. crouch or equinus) in CP result in slow, inefficient walking [14]. We hypothesize that
      the individualized ankle angle, leg segment alignment, and footwear profiles of the AFO-FCs
      will optimize lower limb joint kinematics, decrease overall gait deviations facilitating
      longer step lengths (improved stance stability), with resultant increased gait speed as
      compared to TSAFO. Instrumented gait analysis will assess gait speed and calculate changes in
      joint specific kinematics with the Gait Profile Score (GPS) and overall combined gait
      kinematics with the GDI.

      Aim 2: Examine the effect of AFO-FC on daily walking activity, balance, mobility, and
      satisfaction as compared to the TSAFO in children with CP. We hypothesize that the AFO-FC
      will positively affect community walking activity levels, balance, physical activity and
      satisfaction as compared to the TSAFO. Walking activity will be captured by the StepWatch ®
      accelerometer; balance by the Pediatric Balance Scale; physical activity by the Patient
      Reported Outcomes Measurement System (PROMIS®) Pediatric Physical Activity and the Gait
      Outcomes Assessment List (GOAL); and satisfaction with device by the Orthotic and Prosthetic
      Users' Survey (OPUS).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study Design and Randomization. A randomized waitlist trial will be used to compare the AFO-FC to TSAFO in ambulatory children with CP.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Primary outcomes are Gait Profile Score (GPS), Gait Deviation Index (GDI), gait speed from three dimensional gait analysis and community walking activity are all collected via technology (three dimensional gait lab, accelerometry, thus masked.
measure: Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics
time frame: 3 months post wearing assigned orthotic intervention
description: The Gait Profile Score (GPS) represents the pattern of deviation as a single number and is derived from the same individual joint/limb gait kinematics as Gait Deviation Index (GDI) The GPS minimum value is 0 and maximum value is 20. A higher score is a worse outcome. An minimally clinically important difference is published to be 1.6 for children with CP.
measure: Change in Right Baseline Gait Deviation Index (GDI) at 3 Months
time frame: 3 months post wearing assigned orthotic intervention
description: Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side left/right. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score > 100 is considered in the normal range. A higher score is a better outcome.
measure: Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months.
time frame: 3 months post wearing assigned orthotic intervention
description: Gait speed will be captured during the three dimensional gait analysis testing. Gait speed is measured in meters per second (m/sec) with range from 0 to ~ 3.0 m/sec for walking in children. A higher number of m/sec is considered a better outcome with minimally clinically important difference (MCID) of .10 m/s for persons with CP.
measure: Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day.
time frame: 3 months post wearing assigned orthotic intervention
description: Community walking activity will be captured by the ankle worn StepWatch ® accelerometer capturing change in average strides/day. The StepWatch ® is a two dimension accelerometer validated to capture when the foot leaves the ground for a metric of stride counts within the context of daily life. Average strides/day can range from 0 to unlimited strides/day. A higher number of strides/day is considered a better outcome.
measure: Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of > 60 Strides/Minute.
time frame: 3 months post wearing assigned orthotic intervention
description: Community walking activity will be captured by the ankle worn StepWatch Accelerometer capturing % time at high stride rates. Percent time at high stride rates (> 60 strides/min) can range from 0 to 100% with a higher percent considered a better outcome.
measure: Change in Left Baseline Gait Deviation Index (GDI) at 3 Months
time frame: Change in Right baseline Gait Deviation Index (GDI) at 3 months
description: Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side LEFT/RIGHT. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score > 100 is considered in the 'normal' range. A higher score is a better outcome.
measure: Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale.
time frame: 3 months post wearing assigned orthotic intervention
description: The Pediatric Balance Scale (PBS) is a functional measure intended to assess balance in a clinical setting for children with neurological impairment. The PBS is a scaled scoring with range of 0 to 100 with a higher score a better outcome.
measure: Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score .
time frame: 3 months post wearing assigned orthotic intervention
description: Gait Outcomes Assessment List (GOAL) - The Gait Outcomes Assessment List (GOAL) is a outcome assessment to evaluate gait priorities and functional mobility for ambulant children with CP. The GOAL range of standard scores is 0 to 100 with a high score a better outcome. The GOAL will allow clinicians to better understand the motor abilities, priorities, and expectations of ambulant children with CP and to improve decision-making about appropriate interventions. The GOAL consists of 48 items grouped into seven domains: 1) activities of daily living and independence; 2) gait function and mobility; 3) pain, discomfort and fatigue; 4) physical activities, sports and recreation; 5) gait pattern and appearance; 6) use of braces and mobility aids; and 7) body image and self-esteem.
measure: Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes.
time frame: 3 months post wearing assigned orthotic intervention
description: Parental report of Physical Function Mobility subscale T-scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric survey. The PROMIS Physical Function subscale T score range is 0 to 100 with a higher score a better outcome. The mean of the T-score for Physical Function Mobility is 50 with a SD of 10, For parental report a score > or equal to 45 is consider Good, 36 - 44 Fair and < or equal to 35 Poor physical Function
measure: Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months
time frame: 3 months post wearing assigned orthotic intervention
description: Parental report of pain/fatigue domain standard scores on the Gait Outcomes Assessment List (GOAL). The range of the pain/fatigue subscale of the GOAL 0 to 100. A higher score is a better outcome.
measure: Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey
time frame: 3 months post wearing assigned orthotic intervention
description: Parental report of selected pain and pain interference items from the Patient-Reported Outcomes Measurement Information System (PROMIS)pediatric survey. The Pediatric PROMIS pain interference subscale T score range is 0 to 100 with a lower score a better outcome. The mean is 50 with SD of 10. For the Pain interference a T score < 50 is considered within normal limits.
measure: Difference Between Groups in Satisfaction With Orthoses/Shoes After Wearing for 3 Months Per Orthotic and Prosthetic Users Survey (OPUS).
time frame: 3 months post wearing assigned orthotic intervention
description: Parental report of satisfaction raw score items from the Orthotic and Prosthetic Users' Survey (OPUS). The range of OPUS scores is 11-55 with a higher score a better outcome. The raw scores are employed as the survey validation for Rasch scores is not completed for children.
arm group label: Ankle Foot Orthoses-Footwear Combination
arm group type: Experimental
description: The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm.
arm group label: Traditional Solid Ankle AFO (TSAFO)
arm group type: Active Comparator
description: The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)...
intervention type: Other
intervention name: Ankle Foot Orthoses-Footwear Combination
description: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.
arm group label: Ankle Foot Orthoses-Footwear Combination
intervention type: Other
intervention name: Traditional Solid Ankle AFO (TSAFO)
description: This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
arm group label: Traditional Solid Ankle AFO (TSAFO)
criteria: 
gender: All
minimum age: 4 Years
maximum age: 9 Years
healthy volunteers: No
last name: Kristie F Bjornson, PhD, PT
role: Principal Investigator
affiliation: Seattle Children's Research Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Kristie Bjornson
investigator title: Associate Professor, Pediatrics
mesh term: Cerebral Palsy
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to hardware failure in Dec 2020, there was a data loss of the gait outcomes at the OrthoCare Biomechanics Lab (gait lab). Thus the gait lab variables of GPS and GDI have a sample size of 13, where all other outcomes have a sample size of 19.
point of contact: 