<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/NCT02225990</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201400568</org_study_id>
    <nct_id>NCT02225990</nct_id>
  </id_info>
  <brief_title>Implementation of Comprehensive Stroke Rehabilitation Therapy for Enhanced Quality of Life</brief_title>
  <acronym>QualPro</acronym>
  <official_title>Implementation of Gait Coordination, Mobility, and Fitness Training for Enhanced Quality of Life and Participation in Life Roles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to implement into clinical practice, the comprehensive&#xD;
      QualPro protocol for stroke survivors, which includes gait coordination, balance, mobility,&#xD;
      and fitness training. Feasibility will be tested in the clinical environment by providing the&#xD;
      intervention, measuring patient outcomes, and identifying the obstacles to insurance payment&#xD;
      for the QualPro intervention. By productively addressing issues of implementation, the&#xD;
      hypotheses of this study include proven feasibility in the clinical environment and&#xD;
      clinically significant gains for stroke patients in the areas of strength, balance, gait&#xD;
      coordination, endurance, physical function, and increased life role participation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This comprehensive intervention targets the impairments preventing recovery to normal and&#xD;
      safe gait, mobility, function, and life role participation (quality of life). It has been&#xD;
      tested in chronic stroke survivors and found efficacious.&#xD;
&#xD;
      The QualPro protocol will include three phases, all of which contain components previously&#xD;
      mentioned. The QualPro protocol includes implementation of gait coordination training to&#xD;
      address weakness, impaired endurance, and dyscoordination. The protocol will include&#xD;
      implementation of balance training for falls prevention composed of Yang style, 24-posture,&#xD;
      short-form Tai Chi. Additionally, the QualPro protocol will include implementation of aerobic&#xD;
      training for fitness, health, and endurance of stroke survivors, which will be composed of&#xD;
      low-volume, high intensity interval training (HIIT) on a cycle ergometer. Strength exercises&#xD;
      will also be included. All exercises will address weakness, impaired endurance, and&#xD;
      dyscoordination.&#xD;
&#xD;
      The long-range financial goal of this research study is to realize the cost savings of&#xD;
      implementing the proposed combination of interventions that will preclude much of the very&#xD;
      costly and downwardly spiraling sequellae currently observed after stroke, and that currently&#xD;
      costs managed care and insurance companies an exorbitant and unnecessary amount of precious&#xD;
      resources.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">December 27, 2018</completion_date>
  <primary_completion_date type="Actual">December 27, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient response to QualPro intervention in the clinical environment</measure>
    <time_frame>24 months</time_frame>
    <description>Implementation of the comprehensive QualPro protocol into clinical practice will be done in order to determine patient outcomes during interventions of gait coordination, balance, mobility, and fitness training.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost savings of implementation of the QualPro Protocol</measure>
    <time_frame>24 Months</time_frame>
    <description>Information with respect to the cost of standard care and cost of the proposed care model will be collected and compiled in order to determine feasibility in the clinical environment.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Standard of Care, Sub-Acute</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive standard of care stroke rehabilitation therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care, Chronic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive standard of care stroke rehabilitation therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group, Sub-Acute</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group consists of sub-acute stroke patients who are between three weeks and six months post-stroke and will receive the QualPro protocol. If the participant is an inpatient at Shands Rehabilitation Hospital at the beginning of the study, his/her first three weeks of research therapy sessions will take place at the Shands Rehabilitation Hospital. After being discharged, the remainder of the study sessions will take place at either UF Health Rehab Center- Magnolia Parke or in the North Tower (6th floor) physical therapy department of Shands Hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group, Chronic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group consists of chronic stroke patients who are greater than six months post-stroke and will receive the QualPro protocol. The study sessions will take place at either UF Health Rehab Center-Magnolia Parke or in the North Tower (6th floor) physical therapy department of Shands Hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Group, Sub-Acute</intervention_name>
    <description>For the sub-acute experimental group, the intervention schedule will be as follows: six months of individual therapy five times weekly (1 - 2.5 hours/session); 6 months of 'refresher' individual therapy twice monthly (1 - 2.5 hours/session) + group therapy up to three times weekly (1 hour/session); and 1 year of group therapy, up to three times weekly (1 hour/session) + 1 'refresher' individual therapy session every 3 months for a total study duration of 2 years.</description>
    <arm_group_label>Experimental Group, Sub-Acute</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental Group, Chronic</intervention_name>
    <description>For the chronic experimental group, the intervention schedule will be as follows: six months of individual therapy five times weekly (1 - 2.5 hours/session); 6 months of 'refresher' individual therapy twice monthly (1 - 2.5 hours/session) + group therapy up to three times weekly (1 hour/session); and 1 year of group therapy, up to three times weekly (1 hour/session) + 1 'refresher' individual therapy session every 3 months for a total study duration of 2 years.</description>
    <arm_group_label>Experimental Group, Chronic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care, Sub-Acute</intervention_name>
    <description>This group will receive standard of care stroke rehabilitation therapy.</description>
    <arm_group_label>Standard of Care, Sub-Acute</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care, Chronic</intervention_name>
    <description>This group will receive standard of care stroke rehabilitation therapy.</description>
    <arm_group_label>Standard of Care, Chronic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cognition sufficiently intact to give valid informed consent to participate.&#xD;
&#xD;
          -  Sufficient endurance to participate in rehabilitation sessions.&#xD;
&#xD;
          -  Ability to follow 2 stage commands.&#xD;
&#xD;
          -  Medically stable&#xD;
&#xD;
          -  Age &gt; 21 years&#xD;
&#xD;
          -  Impaired ambulation as follows: inability to flex the knee and ankle in the sagittal&#xD;
             plane, in a normal manner so the foot clears the floor; inability to control normal&#xD;
             knee angle during single limb weight bearing during stance phase.&#xD;
&#xD;
          -  Trace contraction of hip, knee, and ankle flexors and extensors.&#xD;
&#xD;
          -  Passive range of motion (ROM) at hip, knee, ankle greater than or equal to normal gait&#xD;
             kinematics.&#xD;
&#xD;
          -  Reported comfort of surface FES at a stimulus level producing a visible or palpable&#xD;
             muscle contraction of ankle dorsiflexors.&#xD;
&#xD;
          -  Greater than 3 weeks post-stroke.&#xD;
&#xD;
          -  Living in the community and able to travel to training and assessment sites.&#xD;
&#xD;
          -  Approval of participation by primary care physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute or progressive cardiac, renal, respiratory, neurological disorders or&#xD;
             malignancy.&#xD;
&#xD;
          -  Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.&#xD;
&#xD;
          -  Lower motor neuron damage or radiculopathy.&#xD;
&#xD;
          -  More than one stroke.&#xD;
&#xD;
          -  Cerebellar dysfunction.&#xD;
&#xD;
          -  Fugl-Meyer lower limb motor sub-score greater than 32.&#xD;
&#xD;
          -  Severe obesity (body mass index &gt; 35)&#xD;
&#xD;
          -  For the chronic group: current participation in physical therapy or cardiopulmonary&#xD;
             rehabilitation.&#xD;
&#xD;
          -  Significant visual impairment affecting capability to gauge movement accuracy.&#xD;
&#xD;
          -  Current enrollment in any clinical trial&#xD;
&#xD;
          -  Planning to relocate out of the greater Gainesville, FL area during the study period&#xD;
&#xD;
          -  Unable to communicate sufficiently with study personnel&#xD;
&#xD;
          -  Clinical judgement regarding safety or non-compliance&#xD;
&#xD;
          -  Refusal to be recorded by video for gait assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janis J. Daly, PhD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF Health Rehab Center- Magnolia Parke</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Shands Rehab Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Rehabilitation Research Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>August 30, 2019</last_update_submitted>
  <last_update_submitted_qc>August 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>stroke rehabilitation</keyword>
  <keyword>stroke therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02225990
org study id: IRB201400568
nct id: NCT02225990
lead sponsor: 
has dmc: No
is fda regulated drug: No
The purpose of this research study is to implement into clinical practice, the comprehensive
      QualPro protocol for stroke survivors, which includes gait coordination, balance, mobility,
      and fitness training. Feasibility will be tested in the clinical environment by providing the
      intervention, measuring patient outcomes, and identifying the obstacles to insurance payment
      for the QualPro intervention. By productively addressing issues of implementation, the
      hypotheses of this study include proven feasibility in the clinical environment and
      clinically significant gains for stroke patients in the areas of strength, balance, gait
      coordination, endurance, physical function, and increased life role participation.
This comprehensive intervention targets the impairments preventing recovery to normal and
      safe gait, mobility, function, and life role participation (quality of life). It has been
      tested in chronic stroke survivors and found efficacious.

      The QualPro protocol will include three phases, all of which contain components previously
      mentioned. The QualPro protocol includes implementation of gait coordination training to
      address weakness, impaired endurance, and dyscoordination. The protocol will include
      implementation of balance training for falls prevention composed of Yang style, 24-posture,
      short-form Tai Chi. Additionally, the QualPro protocol will include implementation of aerobic
      training for fitness, health, and endurance of stroke survivors, which will be composed of
      low-volume, high intensity interval training (HIIT) on a cycle ergometer. Strength exercises
      will also be included. All exercises will address weakness, impaired endurance, and
      dyscoordination.

      The long-range financial goal of this research study is to realize the cost savings of
      implementing the proposed combination of interventions that will preclude much of the very
      costly and downwardly spiraling sequellae currently observed after stroke, and that currently
      costs managed care and insurance companies an exorbitant and unnecessary amount of precious
      resources.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient response to QualPro intervention in the clinical environment
time frame: 24 months
description: Implementation of the comprehensive QualPro protocol into clinical practice will be done in order to determine patient outcomes during interventions of gait coordination, balance, mobility, and fitness training.
measure: Cost savings of implementation of the QualPro Protocol
time frame: 24 Months
description: Information with respect to the cost of standard care and cost of the proposed care model will be collected and compiled in order to determine feasibility in the clinical environment.
arm group label: Standard of Care, Sub-Acute
arm group type: Active Comparator
description: This group will receive standard of care stroke rehabilitation therapy.
arm group label: Standard of Care, Chronic
arm group type: Active Comparator
description: This group will receive standard of care stroke rehabilitation therapy.
arm group label: Experimental Group, Sub-Acute
arm group type: Experimental
description: This group consists of sub-acute stroke patients who are between three weeks and six months post-stroke and will receive the QualPro protocol. If the participant is an inpatient at Shands Rehabilitation Hospital at the beginning of the study, his/her first three weeks of research therapy sessions will take place at the Shands Rehabilitation Hospital. After being discharged, the remainder of the study sessions will take place at either UF Health Rehab Center- Magnolia Parke or in the North Tower (6th floor) physical therapy department of Shands Hospital.
arm group label: Experimental Group, Chronic
arm group type: Experimental
description: This group consists of chronic stroke patients who are greater than six months post-stroke and will receive the QualPro protocol. The study sessions will take place at either UF Health Rehab Center-Magnolia Parke or in the North Tower (6th floor) physical therapy department of Shands Hospital.
intervention type: Other
intervention name: Experimental Group, Sub-Acute
description: For the sub-acute experimental group, the intervention schedule will be as follows: six months of individual therapy five times weekly (1 - 2.5 hours/session); 6 months of 'refresher' individual therapy twice monthly (1 - 2.5 hours/session) + group therapy up to three times weekly (1 hour/session); and 1 year of group therapy, up to three times weekly (1 hour/session) + 1 'refresher' individual therapy session every 3 months for a total study duration of 2 years.
arm group label: Experimental Group, Sub-Acute
intervention type: Other
intervention name: Experimental Group, Chronic
description: For the chronic experimental group, the intervention schedule will be as follows: six months of individual therapy five times weekly (1 - 2.5 hours/session); 6 months of 'refresher' individual therapy twice monthly (1 - 2.5 hours/session) + group therapy up to three times weekly (1 hour/session); and 1 year of group therapy, up to three times weekly (1 hour/session) + 1 'refresher' individual therapy session every 3 months for a total study duration of 2 years.
arm group label: Experimental Group, Chronic
intervention type: Other
intervention name: Standard of Care, Sub-Acute
description: This group will receive standard of care stroke rehabilitation therapy.
arm group label: Standard of Care, Sub-Acute
intervention type: Other
intervention name: Standard of Care, Chronic
description: This group will receive standard of care stroke rehabilitation therapy.
arm group label: Standard of Care, Chronic
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
last name: Janis J. Daly, PhD, MS
role: Principal Investigator
affiliation: University of Florida
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Undecided