<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/NCT02196298</url>
  </required_header>
  <id_info>
    <org_study_id>12-293</org_study_id>
    <nct_id>NCT02196298</nct_id>
  </id_info>
  <brief_title>A Randomized Trial Comparing the Lokomat® With a Gait-related Physiotherapy Program in Children With Cerebral Palsy</brief_title>
  <official_title>A Randomized Cross-over Clinical Trial Comparing the Impact of the Lokomat® Gait Training System With a Gait-related Physiotherapy Program in Children With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Holland Bloorview Kids Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CIBC Children's Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Holland Bloorview Kids Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Lokomat is a robotic treadmill gait trainer that is used to help people who have&#xD;
      neurologic conditions walk better. Early research with children with cerebral palsy (CP)&#xD;
      shows that it may help to improve walking skills. The purpose of this two-group randomized&#xD;
      study is to compare Lokomat training to regular physiotherapy (PT) as far as impact on&#xD;
      walking abilities and related function. The primary (alternate) hypothesis is that children&#xD;
      will improve more with Lokomat training in terms of gross motor skills and walking endurance.&#xD;
&#xD;
      The investigators are enrolling 40 ambulatory children who are ages 5 to 12 years, have CP&#xD;
      and are in Gross Motor Function Classification System (GMFCS) Level II (n=20) or III (n=20).&#xD;
      In this crossover randomized clinical trial (RCT), whether PT or Lokomat intervention is done&#xD;
      first is decided by an independent randomization process that occurs after the first baseline&#xD;
      assessment. In the Lokomat phase, children receive 8 to 10 weeks of twice weekly therapy for&#xD;
      a maximum of 16 sessions. Each session is 35 minutes plus the time needed for set-up. The 35&#xD;
      minute PT program is also given twice weekly for 8 to 10 weeks for a maximum of 16 sessions,&#xD;
      and focuses on a menu-based strength, co-ordination, fitness, walking and balance activities.&#xD;
      There is a 6 week break between the Lokomat and PT interventions.&#xD;
&#xD;
      Each child has four study assessments during their ~6 months in the study. The first&#xD;
      assessment is done before starting the Lokomat or physiotherapy phase. The second happens&#xD;
      after the first intervention has finished. The child then has a 6-week break period. The&#xD;
      third assessment is done at the end of this break, and the fourth occurs after the second&#xD;
      intervention. The PT assessor who does these assessments will not be the same as the PT who&#xD;
      gives the intervention. The assessor is blinded to the child's intervention phase and&#xD;
      previous assessment results. The primary outcome measures are the Gross Motor Function&#xD;
      Measure and 6 minute walk test. Secondary measures evaluate gait, functional abilities,&#xD;
      participation, health related quality of life and individualized goals.&#xD;
&#xD;
      The randomized aspect of the study lets us look at outcome differences between children for&#xD;
      Lokomat and PT within their first intervention phase (n=20/group). The cross-over phase&#xD;
      evaluates within-child outcomes across the two phases. A qualitative component is&#xD;
      concurrently underway to examine child/parent experiences and their views of Lokomat&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No further information&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">January 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Stand and Walk items of the GMFM-66. Gold standard measure of foundational gross motor skills in children with CP.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in walk speed on the Six-minute walk test at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Used as the co-primary outcome measure. Standardized 6 minute walk test (with shoes, orthoses, walking devices as required) to determine distance covered (capability measure). Well-validated in pediatric CP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in advanced motor skills on the Challenge Module at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Just for children in GMFCS Level II. This is a new published measure of advanced motor skills.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in activity and participation on the Activities Scale for Kids at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Well-validated measure of physical functional ability in children. Child (if 8+ years) or parent-report questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in quality of life on the KidScreen Questionnaire at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Measure of health-related quality of life. Questionnaire completed by children 8+ years or parents of younger children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in participation on the Children's Assessment of Participation and Enjoyment (CAPE) at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Using the physical activity and sport sections of this parent-report questionnaire to gain picture of areas/extent of participation in these areas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in gait kinematics as measured on the GaitRite evaluation system at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Time distance parameters of gait via GaitRite system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Gait quality as measured on an observational gait scale at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Gait pattern as evaluated via observational gait scale, rating from video of child's walking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS) at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Three to five individualized walking-based activity/participation goals set with child/parent/treating PT at baseline 1 and reset at baseline 2. Evaluated by treating PT with child/parent input at post-intervention 1 and 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Three to five individualized walking-based activity/participation set at baseline 1 and 2 with assessor and child/parent, and re-evaluated by child/parent at post-intervention assessment 1 and 2. Used by treating PT to formulate GAS goals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in movement quality as measured by the Quality Function Measure (QFM) at week 8</measure>
    <time_frame>Baseline, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Companion measure to the GMFM-66 to assess alignment, co-ordination, dissociated movement, stability and weight shift. Rated by PT assessor from GMFM video. Recently validated.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment of mastery motivation using the Dimensions of Mastery Questionnaire at the first baseline</measure>
    <time_frame>Baseline 1 only</time_frame>
    <description>This measure of a child's motivation and persistence with difficult tasks is a measure of traits rather than outcome. Not expected to change so being used instead as a possible predictor of outcomes. Questionnaire completed by child (if 8+ years) or parent-report questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Monitoring of range of motion (ROM) of hip, knee and ankle</measure>
    <time_frame>baseline, 4 weeks, 8 weeks (repeated in same manner after crossover)</time_frame>
    <description>Hip, knee, ankle - passive ROM</description>
  </other_outcome>
  <other_outcome>
    <measure>Body pain</measure>
    <time_frame>participants will be followed at each treatment session for the duration of the study, an expected average of 16 weeks (8 weeks in the Lokomat arm and 8 weeks in the PT arm)</time_frame>
    <description>Use of FACES pain scale and body diagrams to show areas of pain (skin and musculoskeletal and other)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Lokomat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>16 sessions in total, 30 minutes each plus set-up time followed by 5 minutes of overground walking. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>16 sessions, 35 minutes. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lokomat</intervention_name>
    <description>16 sessions in total, 30 minutes each plus set-up time followed by 5 minutes of overground walking. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.</description>
    <arm_group_label>Lokomat</arm_group_label>
    <other_name>Lokomat®Pro Pediatric Orthoses</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>16 sessions, 35 minutes. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.</description>
    <arm_group_label>Physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 5 to12 years inclusive&#xD;
&#xD;
          -  assessed as GMFCS Levels II or III&#xD;
&#xD;
          -  able to follow testing instructions, and participate in a minimum of 30 minutes of&#xD;
             active PT&#xD;
&#xD;
          -  able to reliably signal pain, fear and discomfort&#xD;
&#xD;
          -  have passive range of motion (ROM) of hips and knees within minimum range requirement&#xD;
             for Lokomat (hip and knee flexion contracture &lt; 10 degrees, and knee valgus &lt; 40&#xD;
             degrees)&#xD;
&#xD;
          -  client of Child Development Program at Holland Bloorview&#xD;
&#xD;
          -  able to commit to attendance of twice weekly for eight weeks (to support the primary&#xD;
             efficacy analysis).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a fixed knee contracture &gt; 10 degrees, knee valgus &gt;40 degrees such that robotic leg&#xD;
             orthosis will not be adaptable to lower limbs&#xD;
&#xD;
          -  hip instability/subluxation &gt; 45%&#xD;
&#xD;
          -  orthopaedic surgery within the last 9 months (muscle) or 12 months (bone)&#xD;
&#xD;
          -  Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months&#xD;
&#xD;
          -  inability to discontinue BTX-A for period of 6 months (during trial) due to concerns&#xD;
             about ROM or pain&#xD;
&#xD;
          -  severe spasticity may be a contraindication&#xD;
&#xD;
          -  any weightbearing restrictions&#xD;
&#xD;
          -  seizure disorder that is not controlled by medication (if on medication, must not have&#xD;
             had a seizure in the last 12 months)&#xD;
&#xD;
          -  open skin lesions or vascular disorder of lower extremities&#xD;
&#xD;
          -  not able to co-operate or be positioned adequately within the Lokomat as shown during&#xD;
             the two Lokomat fitting/acclimatisation sessions&#xD;
&#xD;
          -  not prepared or unable to discontinue a regular therapy intervention during the course&#xD;
             of the trial&#xD;
&#xD;
          -  involved in another intervention study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virginia Wright, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Holland Bloorview Kids Rehabiltation Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Darcy Fehlings, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Holland Bloorview Kids Rehabiltation Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Holland Bloorview Kids Rehabiltation Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4G 1R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.hollandbloorview.ca</url>
    <description>Website of facility where trial is occurring. Investigators' lab sites are also on that website</description>
  </link>
  <reference>
    <citation>Hilderley AJ, Fehlings D, Lee GW, Wright FV. Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Springerplus. 2016 Oct 28;5(1):1886. doi: 10.1186/s40064-016-3535-0. eCollection 2016.</citation>
    <PMID>27843743</PMID>
  </reference>
  <reference>
    <citation>Phelan SK, Gibson BE, Wright FV. What is it like to walk with the help of a robot? Children's perspectives on robotic gait training technology. Disabil Rehabil. 2015;37(24):2272-81. doi: 10.3109/09638288.2015.1019648. Epub 2015 Apr 9.</citation>
    <PMID>25856202</PMID>
  </reference>
  <reference>
    <citation>Beveridge B, Feltracco D, Struyf J, Strauss E, Dang S, Phelan S, Wright FV, Gibson BE. &quot;You gotta try it all&quot;: Parents' Experiences with Robotic Gait Training for their Children with Cerebral Palsy. Phys Occup Ther Pediatr. 2015;35(4):327-41. doi: 10.3109/01942638.2014.990547. Epub 2014 Dec 20.</citation>
    <PMID>25529412</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>April 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Holland Bloorview Kids Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>Virginia Wright</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>physical therapy</keyword>
  <keyword>gait</keyword>
  <keyword>pediatric rehabilitation</keyword>
  <keyword>gross motor function</keyword>
  <keyword>participation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02196298
org study id: 12-293
nct id: NCT02196298
lead sponsor: 
collaborator: 
has dmc: Yes
The Lokomat is a robotic treadmill gait trainer that is used to help people who have
      neurologic conditions walk better. Early research with children with cerebral palsy (CP)
      shows that it may help to improve walking skills. The purpose of this two-group randomized
      study is to compare Lokomat training to regular physiotherapy (PT) as far as impact on
      walking abilities and related function. The primary (alternate) hypothesis is that children
      will improve more with Lokomat training in terms of gross motor skills and walking endurance.

      The investigators are enrolling 40 ambulatory children who are ages 5 to 12 years, have CP
      and are in Gross Motor Function Classification System (GMFCS) Level II (n=20) or III (n=20).
      In this crossover randomized clinical trial (RCT), whether PT or Lokomat intervention is done
      first is decided by an independent randomization process that occurs after the first baseline
      assessment. In the Lokomat phase, children receive 8 to 10 weeks of twice weekly therapy for
      a maximum of 16 sessions. Each session is 35 minutes plus the time needed for set-up. The 35
      minute PT program is also given twice weekly for 8 to 10 weeks for a maximum of 16 sessions,
      and focuses on a menu-based strength, co-ordination, fitness, walking and balance activities.
      There is a 6 week break between the Lokomat and PT interventions.

      Each child has four study assessments during their ~6 months in the study. The first
      assessment is done before starting the Lokomat or physiotherapy phase. The second happens
      after the first intervention has finished. The child then has a 6-week break period. The
      third assessment is done at the end of this break, and the fourth occurs after the second
      intervention. The PT assessor who does these assessments will not be the same as the PT who
      gives the intervention. The assessor is blinded to the child's intervention phase and
      previous assessment results. The primary outcome measures are the Gross Motor Function
      Measure and 6 minute walk test. Secondary measures evaluate gait, functional abilities,
      participation, health related quality of life and individualized goals.

      The randomized aspect of the study lets us look at outcome differences between children for
      Lokomat and PT within their first intervention phase (n=20/group). The cross-over phase
      evaluates within-child outcomes across the two phases. A qualitative component is
      concurrently underway to examine child/parent experiences and their views of Lokomat
      outcomes.
No further information
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Stand and Walk items of the GMFM-66. Gold standard measure of foundational gross motor skills in children with CP.
measure: Change from baseline in walk speed on the Six-minute walk test at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Used as the co-primary outcome measure. Standardized 6 minute walk test (with shoes, orthoses, walking devices as required) to determine distance covered (capability measure). Well-validated in pediatric CP.
measure: Change from baseline in advanced motor skills on the Challenge Module at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Just for children in GMFCS Level II. This is a new published measure of advanced motor skills.
measure: Change from baseline in activity and participation on the Activities Scale for Kids at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Well-validated measure of physical functional ability in children. Child (if 8+ years) or parent-report questionnaire
measure: Change from baseline in quality of life on the KidScreen Questionnaire at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Measure of health-related quality of life. Questionnaire completed by children 8+ years or parents of younger children.
measure: Change from baseline in participation on the Children's Assessment of Participation and Enjoyment (CAPE) at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Using the physical activity and sport sections of this parent-report questionnaire to gain picture of areas/extent of participation in these areas.
measure: Change from baseline in gait kinematics as measured on the GaitRite evaluation system at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Time distance parameters of gait via GaitRite system
measure: Change from baseline in Gait quality as measured on an observational gait scale at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Gait pattern as evaluated via observational gait scale, rating from video of child's walking
measure: Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS) at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Three to five individualized walking-based activity/participation goals set with child/parent/treating PT at baseline 1 and reset at baseline 2. Evaluated by treating PT with child/parent input at post-intervention 1 and 2
measure: Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Three to five individualized walking-based activity/participation set at baseline 1 and 2 with assessor and child/parent, and re-evaluated by child/parent at post-intervention assessment 1 and 2. Used by treating PT to formulate GAS goals
measure: Change from baseline in movement quality as measured by the Quality Function Measure (QFM) at week 8
time frame: Baseline, 8 weeks (repeated in same manner after crossover)
description: Companion measure to the GMFM-66 to assess alignment, co-ordination, dissociated movement, stability and weight shift. Rated by PT assessor from GMFM video. Recently validated.
measure: Assessment of mastery motivation using the Dimensions of Mastery Questionnaire at the first baseline
time frame: Baseline 1 only
description: This measure of a child's motivation and persistence with difficult tasks is a measure of traits rather than outcome. Not expected to change so being used instead as a possible predictor of outcomes. Questionnaire completed by child (if 8+ years) or parent-report questionnaire
measure: Monitoring of range of motion (ROM) of hip, knee and ankle
time frame: baseline, 4 weeks, 8 weeks (repeated in same manner after crossover)
description: Hip, knee, ankle - passive ROM
measure: Body pain
time frame: participants will be followed at each treatment session for the duration of the study, an expected average of 16 weeks (8 weeks in the Lokomat arm and 8 weeks in the PT arm)
description: Use of FACES pain scale and body diagrams to show areas of pain (skin and musculoskeletal and other)
arm group label: Lokomat
arm group type: Experimental
description: 16 sessions in total, 30 minutes each plus set-up time followed by 5 minutes of overground walking. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.
arm group label: Physiotherapy
arm group type: Active Comparator
description: 16 sessions, 35 minutes. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.
intervention type: Device
intervention name: Lokomat
description: 16 sessions in total, 30 minutes each plus set-up time followed by 5 minutes of overground walking. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.
arm group label: Lokomat
other name: Lokomat®Pro Pediatric Orthoses
intervention type: Other
intervention name: Physiotherapy
description: 16 sessions, 35 minutes. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.
arm group label: Physiotherapy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: No
last name: Virginia Wright, PT, PhD
role: Principal Investigator
affiliation: Holland Bloorview Kids Rehabiltation Hospital
last name: Darcy Fehlings, MD, MSc
role: Principal Investigator
affiliation: Holland Bloorview Kids Rehabiltation Hospital
facility: 
country: Canada
url: http://www.hollandbloorview.ca
description: Website of facility where trial is occurring. Investigators' lab sites are also on that website
citation: Hilderley AJ, Fehlings D, Lee GW, Wright FV. Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Springerplus. 2016 Oct 28;5(1):1886. doi: 10.1186/s40064-016-3535-0. eCollection 2016.
PMID: 27843743
citation: Phelan SK, Gibson BE, Wright FV. What is it like to walk with the help of a robot? Children's perspectives on robotic gait training technology. Disabil Rehabil. 2015;37(24):2272-81. doi: 10.3109/09638288.2015.1019648. Epub 2015 Apr 9.
PMID: 25856202
citation: Beveridge B, Feltracco D, Struyf J, Strauss E, Dang S, Phelan S, Wright FV, Gibson BE. "You gotta try it all": Parents' Experiences with Robotic Gait Training for their Children with Cerebral Palsy. Phys Occup Ther Pediatr. 2015;35(4):327-41. doi: 10.3109/01942638.2014.990547. Epub 2014 Dec 20.
PMID: 25529412
responsible party type: Principal Investigator
investigator affiliation: Holland Bloorview Kids Rehabilitation Hospital
investigator full name: Virginia Wright
investigator title: Senior Scientist
mesh term: Cerebral Palsy