<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/NCT03819764</url>
  </required_header>
  <id_info>
    <org_study_id>18-734</org_study_id>
    <nct_id>NCT03819764</nct_id>
  </id_info>
  <brief_title>Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation</brief_title>
  <official_title>Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether aerobic exercise improves the&#xD;
      participant's ability to recover function in the arm and leg affected by the participant's&#xD;
      stroke. The investigators are also calculating the cost effectiveness of the rehabilitation&#xD;
      interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims of the study are to determine the clinical efficacy and cost-effectiveness of&#xD;
      combining aerobic exercise training with upper extremity motor task practice to improve motor&#xD;
      recovery following stroke. It is hypothesized that the neurophysiologic impact of aerobic&#xD;
      exercise may augment motor recovery associated with motor task practice. To test this&#xD;
      hypothesize, 60 individuals with chronic stroke will be recruited to participate in this&#xD;
      randomized clinical trial. Following screening and informed consent, all participants will&#xD;
      undergo an exercise stress test to determine response to maximal exertion. Following the&#xD;
      stress test, baseline clinical assessments will be obtained to quantify upper extremity&#xD;
      function, gait, endurance, and self-reported quality of life. Additionally, variables to&#xD;
      determine degree of disability will be obtained. Individuals will be randomized to one of two&#xD;
      interventions: 45 min of forced-rate aerobic exercise paired with 45 min of upper limb&#xD;
      repetitive task practice or two back-to-back 45-minute sessions of upper limb repetitive task&#xD;
      practice. The interventions will occur 3 times per week for 8 weeks. Outcomes assessing motor&#xD;
      function and disability will be repeated at mid-treatment, end of treatment, and at 4 weeks,&#xD;
      6-months and 12-months following end of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 11, 2019</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>Baseline</time_frame>
    <description>This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>midpoint (4 weeks from Baseline)</time_frame>
    <description>This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>end of treatment +4 weeks (12 weeks from Baseline)</time_frame>
    <description>This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>end of treatment +6 months (8 months from Baseline)</time_frame>
    <description>This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>end of treatment +1 year (14 months from Baseline)</time_frame>
    <description>This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>Baseline</time_frame>
    <description>This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>end of treatment +4 weeks (12 weeks from Baseline)</time_frame>
    <description>This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>end of treatment +6 months (8 months from Baseline)</time_frame>
    <description>This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Action Research Arm Test (ARAT)</measure>
    <time_frame>end of treatment +1 year (14 months from Baseline)</time_frame>
    <description>This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wolf Motor Function Test (WMFT)</measure>
    <time_frame>Baseline</time_frame>
    <description>This consists of 2 strength tasks and 15 timed tasks of both the affected upper extremity and the unaffected upper extremity. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wolf Motor Function Test (WMFT)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>This consists of 2 strength tasks and 15 timed tasks of both the affected upper extremity and the unaffected upper extremity. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale (SIS)</measure>
    <time_frame>Baseline</time_frame>
    <description>This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale (SIS)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale (SIS)</measure>
    <time_frame>end of treatment +6 months (8 months from Baseline)</time_frame>
    <description>This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale (SIS)</measure>
    <time_frame>end of treatment +1 year (14 months from Baseline)</time_frame>
    <description>This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS-29)</measure>
    <time_frame>Baseline</time_frame>
    <description>A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.&#xD;
A score of 40 is one standard deviation lower than the mean of the reference population.&#xD;
A score of 60 is one standard deviation higher than the mean of the reference population.&#xD;
For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS-29)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.&#xD;
A score of 40 is one standard deviation lower than the mean of the reference population.&#xD;
A score of 60 is one standard deviation higher than the mean of the reference population.&#xD;
For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS-29)</measure>
    <time_frame>end of treatment +6 months (8 months from Baseline)</time_frame>
    <description>A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.&#xD;
A score of 40 is one standard deviation lower than the mean of the reference population.&#xD;
A score of 60 is one standard deviation higher than the mean of the reference population.&#xD;
For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS-29)</measure>
    <time_frame>end of treatment +1 year (14 months from Baseline)</time_frame>
    <description>A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.&#xD;
A score of 40 is one standard deviation lower than the mean of the reference population.&#xD;
A score of 60 is one standard deviation higher than the mean of the reference population.&#xD;
For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies-Depression (CES-D)</measure>
    <time_frame>Baseline</time_frame>
    <description>This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies-Depression (CES-D)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies-Depression (CES-D)</measure>
    <time_frame>end of treatment +6 months (8 months from Baseline)</time_frame>
    <description>This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies-Depression (CES-D)</measure>
    <time_frame>end of treatment +1 year (14 months from Baseline)</time_frame>
    <description>This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-Minute Walk Test (6MWT)</measure>
    <time_frame>Baseline</time_frame>
    <description>Total distance (feet) traveled over a 6 minute period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-Minute Walk Test (6MWT)</measure>
    <time_frame>end of treatment (8 weeks)</time_frame>
    <description>Total distance (feet) traveled over a 6 minute period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-Minute Walk Test (6MWT)</measure>
    <time_frame>end of treatment +4 weeks (12 weeks from Baseline)</time_frame>
    <description>Total distance (feet) traveled over a 6 minute period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-Minute Walk Test (6MWT)</measure>
    <time_frame>end of treatment +6 months (8 months from Baseline)</time_frame>
    <description>Total distance (feet) traveled over a 6 minute period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-Minute Walk Test (6MWT)</measure>
    <time_frame>end of treatment +1 year (14 months from Baseline)</time_frame>
    <description>Total distance (feet) traveled over a 6 minute period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>end of treatment +6 months (8 months from Baseline)</time_frame>
    <description>0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>end of treatment +1 year (14 months from Baseline)</time_frame>
    <description>0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Step Length</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean right step length (cm) across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Step Length</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean right step length (cm) across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Step Length</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean left step length (cm) across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Step Length</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean left step length (cm) across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Step Width</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean right step width (cm) across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Step Width</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean right step width (cm) across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Step Width</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean left step width (cm) across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Step Width</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean left step width (cm) across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Stance Time</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Stance Time</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Stance Time</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Stance Time</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Swing Time</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Swing Time</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Swing Time</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Swing Time</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Speed</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean m/s across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Speed</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean m/s across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Cadence</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean steps/minute across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Cadence</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean steps/minute across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Knee Range of Motion</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean peak degree of left knee flexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Knee Range of Motion</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean peak degree of left knee flexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Knee Range of Motion</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean peak degree of right knee flexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Knee Range of Motion</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean peak degree of right knee flexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ankle Range of Motion</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ankle Range of Motion</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Ankle Range of Motion</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Ankle Range of Motion</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Hip Range of Motion (sagittal plane)</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean peak degree of left hip flexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Hip Range of Motion (sagittal plane)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean peak degree of left hip flexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Hip Range of Motion (sagittal plane)</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean peak degree of right hip flexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Hip Range of Motion (sagittal plane)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean peak degree of right hip flexion across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Hip Range of Motion (coronal plane)</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean peak degree of left hip abduction across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Hip Range of Motion (coronal plane)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean peak degree of left hip abduction across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Hip Range of Motion (coronal plane)</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean peak degree of right hip abduction across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Hip Range of Motion (coronal plane)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean peak degree of right hip abduction across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Hip Range of Motion (transverse plane)</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean peak degree of left hip external rotation across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Hip Range of Motion (transverse plane)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean peak degree of left hip external rotation across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Hip Range of Motion (transverse plane)</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean peak degree of right hip external rotation across two 2-minute walking trials</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right Hip Range of Motion (transverse plane)</measure>
    <time_frame>end of treatment (8 weeks from Baseline)</time_frame>
    <description>Mean peak degree of right hip external rotation across two 2-minute walking trials</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Stroke</condition>
  <condition>Cerebrovascular Disorders</condition>
  <condition>Brain Diseases</condition>
  <condition>Central Nervous System Diseases</condition>
  <condition>Nervous System Diseases</condition>
  <condition>Vascular Diseases</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Aerobic Exercise &amp; Repetitive Task Practice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will perform the following:&#xD;
45 minutes of cycling&#xD;
45 minutes of upper extremity repetitive arm exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Upper Extremity Repetitive Task Practice Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will perform the following:&#xD;
1. 90 minutes of upper extremity repetitive arm exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic Exercise</intervention_name>
    <description>Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed</description>
    <arm_group_label>Aerobic Exercise &amp; Repetitive Task Practice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Upper Extremity Repetitive Task Practice</intervention_name>
    <description>Repetitive arm exercises</description>
    <arm_group_label>Aerobic Exercise &amp; Repetitive Task Practice</arm_group_label>
    <arm_group_label>Upper Extremity Repetitive Task Practice Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 6 months following single ischemic or hemorrhagic stroke confirmed with&#xD;
             neuroimaging,&#xD;
&#xD;
          2. Fugl-Meyer motor score 19-55 in the involved upper extremity,&#xD;
&#xD;
          3. Ambulatory ≥ 20 meters with no more than contact guard assistance, and&#xD;
&#xD;
          4. 18-85 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. hospitalization for myocardial infarction, heart failure or heart surgery within 3&#xD;
             months,&#xD;
&#xD;
          2. cardiac arrhythmia,&#xD;
&#xD;
          3. hypertrophic cardiomyopathy,&#xD;
&#xD;
          4. severe aortic stenosis,&#xD;
&#xD;
          5. pulmonary embolus,&#xD;
&#xD;
          6. significant contractures,&#xD;
&#xD;
          7. anti-spasticity injection within 3 months of enrollment and&#xD;
&#xD;
          8. other contraindication to exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Linder, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Main Campus</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Susan Linder</investigator_full_name>
    <investigator_title>Project Scientist, Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>aerobic exercise</keyword>
  <keyword>forced exercise</keyword>
  <keyword>repetitive task practice</keyword>
  <keyword>arm function</keyword>
  <keyword>upper extremity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 6, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03819764/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03819764
org study id: 18-734
nct id: NCT03819764
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate whether aerobic exercise improves the
      participant's ability to recover function in the arm and leg affected by the participant's
      stroke. The investigators are also calculating the cost effectiveness of the rehabilitation
      interventions.
The aims of the study are to determine the clinical efficacy and cost-effectiveness of
      combining aerobic exercise training with upper extremity motor task practice to improve motor
      recovery following stroke. It is hypothesized that the neurophysiologic impact of aerobic
      exercise may augment motor recovery associated with motor task practice. To test this
      hypothesize, 60 individuals with chronic stroke will be recruited to participate in this
      randomized clinical trial. Following screening and informed consent, all participants will
      undergo an exercise stress test to determine response to maximal exertion. Following the
      stress test, baseline clinical assessments will be obtained to quantify upper extremity
      function, gait, endurance, and self-reported quality of life. Additionally, variables to
      determine degree of disability will be obtained. Individuals will be randomized to one of two
      interventions: 45 min of forced-rate aerobic exercise paired with 45 min of upper limb
      repetitive task practice or two back-to-back 45-minute sessions of upper limb repetitive task
      practice. The interventions will occur 3 times per week for 8 weeks. Outcomes assessing motor
      function and disability will be repeated at mid-treatment, end of treatment, and at 4 weeks,
      6-months and 12-months following end of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fugl-Meyer Assessment (FMA)
time frame: Baseline
description: This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
measure: Fugl-Meyer Assessment (FMA)
time frame: midpoint (4 weeks from Baseline)
description: This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
measure: Fugl-Meyer Assessment (FMA)
time frame: end of treatment (8 weeks from Baseline)
description: This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
measure: Fugl-Meyer Assessment (FMA)
time frame: end of treatment +4 weeks (12 weeks from Baseline)
description: This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
measure: Fugl-Meyer Assessment (FMA)
time frame: end of treatment +6 months (8 months from Baseline)
description: This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
measure: Fugl-Meyer Assessment (FMA)
time frame: end of treatment +1 year (14 months from Baseline)
description: This is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
measure: Action Research Arm Test (ARAT)
time frame: Baseline
description: This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
measure: Action Research Arm Test (ARAT)
time frame: end of treatment (8 weeks from Baseline)
description: This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
measure: Action Research Arm Test (ARAT)
time frame: end of treatment +4 weeks (12 weeks from Baseline)
description: This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
measure: Action Research Arm Test (ARAT)
time frame: end of treatment +6 months (8 months from Baseline)
description: This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
measure: Action Research Arm Test (ARAT)
time frame: end of treatment +1 year (14 months from Baseline)
description: This is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
measure: Wolf Motor Function Test (WMFT)
time frame: Baseline
description: This consists of 2 strength tasks and 15 timed tasks of both the affected upper extremity and the unaffected upper extremity. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
measure: Wolf Motor Function Test (WMFT)
time frame: end of treatment (8 weeks from Baseline)
description: This consists of 2 strength tasks and 15 timed tasks of both the affected upper extremity and the unaffected upper extremity. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
measure: Stroke Impact Scale (SIS)
time frame: Baseline
description: This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.
measure: Stroke Impact Scale (SIS)
time frame: end of treatment (8 weeks from Baseline)
description: This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.
measure: Stroke Impact Scale (SIS)
time frame: end of treatment +6 months (8 months from Baseline)
description: This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.
measure: Stroke Impact Scale (SIS)
time frame: end of treatment +1 year (14 months from Baseline)
description: This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
time frame: Baseline
description: A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.
A score of 40 is one standard deviation lower than the mean of the reference population.
A score of 60 is one standard deviation higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
time frame: end of treatment (8 weeks from Baseline)
description: A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.
A score of 40 is one standard deviation lower than the mean of the reference population.
A score of 60 is one standard deviation higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
time frame: end of treatment +6 months (8 months from Baseline)
description: A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.
A score of 40 is one standard deviation lower than the mean of the reference population.
A score of 60 is one standard deviation higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
time frame: end of treatment +1 year (14 months from Baseline)
description: A self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference.
A score of 40 is one standard deviation lower than the mean of the reference population.
A score of 60 is one standard deviation higher than the mean of the reference population.
For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
measure: Center for Epidemiological Studies-Depression (CES-D)
time frame: Baseline
description: This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.
measure: Center for Epidemiological Studies-Depression (CES-D)
time frame: end of treatment (8 weeks from Baseline)
description: This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.
measure: Center for Epidemiological Studies-Depression (CES-D)
time frame: end of treatment +6 months (8 months from Baseline)
description: This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.
measure: Center for Epidemiological Studies-Depression (CES-D)
time frame: end of treatment +1 year (14 months from Baseline)
description: This is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression.
measure: Six-Minute Walk Test (6MWT)
time frame: Baseline
description: Total distance (feet) traveled over a 6 minute period.
measure: Six-Minute Walk Test (6MWT)
time frame: end of treatment (8 weeks)
description: Total distance (feet) traveled over a 6 minute period.
measure: Six-Minute Walk Test (6MWT)
time frame: end of treatment +4 weeks (12 weeks from Baseline)
description: Total distance (feet) traveled over a 6 minute period.
measure: Six-Minute Walk Test (6MWT)
time frame: end of treatment +6 months (8 months from Baseline)
description: Total distance (feet) traveled over a 6 minute period.
measure: Six-Minute Walk Test (6MWT)
time frame: end of treatment +1 year (14 months from Baseline)
description: Total distance (feet) traveled over a 6 minute period.
measure: Modified Rankin Scale
time frame: Baseline
description: 0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.
measure: Modified Rankin Scale
time frame: end of treatment (8 weeks from Baseline)
description: 0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.
measure: Modified Rankin Scale
time frame: end of treatment +6 months (8 months from Baseline)
description: 0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.
measure: Modified Rankin Scale
time frame: end of treatment +1 year (14 months from Baseline)
description: 0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.
measure: Right Step Length
time frame: Baseline
description: Mean right step length (cm) across two 2-minute walking trials
measure: Right Step Length
time frame: end of treatment (8 weeks from Baseline)
description: Mean right step length (cm) across two 2-minute walking trials
measure: Left Step Length
time frame: Baseline
description: Mean left step length (cm) across two 2-minute walking trials
measure: Left Step Length
time frame: end of treatment (8 weeks from Baseline)
description: Mean left step length (cm) across two 2-minute walking trials
measure: Right Step Width
time frame: Baseline
description: Mean right step width (cm) across two 2-minute walking trials
measure: Right Step Width
time frame: end of treatment (8 weeks from Baseline)
description: Mean right step width (cm) across two 2-minute walking trials
measure: Left Step Width
time frame: Baseline
description: Mean left step width (cm) across two 2-minute walking trials
measure: Left Step Width
time frame: end of treatment (8 weeks from Baseline)
description: Mean left step width (cm) across two 2-minute walking trials
measure: Right Stance Time
time frame: Baseline
description: Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials
measure: Right Stance Time
time frame: end of treatment (8 weeks from Baseline)
description: Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials
measure: Left Stance Time
time frame: Baseline
description: Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials
measure: Left Stance Time
time frame: end of treatment (8 weeks from Baseline)
description: Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials
measure: Right Swing Time
time frame: Baseline
description: Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials
measure: Right Swing Time
time frame: end of treatment (8 weeks from Baseline)
description: Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials
measure: Left Swing Time
time frame: Baseline
description: Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials
measure: Left Swing Time
time frame: end of treatment (8 weeks from Baseline)
description: Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials
measure: Walking Speed
time frame: Baseline
description: Mean m/s across two 2-minute walking trials
measure: Walking Speed
time frame: end of treatment (8 weeks from Baseline)
description: Mean m/s across two 2-minute walking trials
measure: Walking Cadence
time frame: Baseline
description: Mean steps/minute across two 2-minute walking trials
measure: Walking Cadence
time frame: end of treatment (8 weeks from Baseline)
description: Mean steps/minute across two 2-minute walking trials
measure: Left Knee Range of Motion
time frame: Baseline
description: Mean peak degree of left knee flexion across two 2-minute walking trials
measure: Left Knee Range of Motion
time frame: end of treatment (8 weeks from Baseline)
description: Mean peak degree of left knee flexion across two 2-minute walking trials
measure: Right Knee Range of Motion
time frame: Baseline
description: Mean peak degree of right knee flexion across two 2-minute walking trials
measure: Right Knee Range of Motion
time frame: end of treatment (8 weeks from Baseline)
description: Mean peak degree of right knee flexion across two 2-minute walking trials
measure: Left Ankle Range of Motion
time frame: Baseline
description: Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials
measure: Left Ankle Range of Motion
time frame: end of treatment (8 weeks from Baseline)
description: Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials
measure: Right Ankle Range of Motion
time frame: Baseline
description: Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials
measure: Right Ankle Range of Motion
time frame: end of treatment (8 weeks from Baseline)
description: Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials
measure: Left Hip Range of Motion (sagittal plane)
time frame: Baseline
description: Mean peak degree of left hip flexion across two 2-minute walking trials
measure: Left Hip Range of Motion (sagittal plane)
time frame: end of treatment (8 weeks from Baseline)
description: Mean peak degree of left hip flexion across two 2-minute walking trials
measure: Right Hip Range of Motion (sagittal plane)
time frame: Baseline
description: Mean peak degree of right hip flexion across two 2-minute walking trials
measure: Right Hip Range of Motion (sagittal plane)
time frame: end of treatment (8 weeks from Baseline)
description: Mean peak degree of right hip flexion across two 2-minute walking trials
measure: Left Hip Range of Motion (coronal plane)
time frame: Baseline
description: Mean peak degree of left hip abduction across two 2-minute walking trials
measure: Left Hip Range of Motion (coronal plane)
time frame: end of treatment (8 weeks from Baseline)
description: Mean peak degree of left hip abduction across two 2-minute walking trials
measure: Right Hip Range of Motion (coronal plane)
time frame: Baseline
description: Mean peak degree of right hip abduction across two 2-minute walking trials
measure: Right Hip Range of Motion (coronal plane)
time frame: end of treatment (8 weeks from Baseline)
description: Mean peak degree of right hip abduction across two 2-minute walking trials
measure: Left Hip Range of Motion (transverse plane)
time frame: Baseline
description: Mean peak degree of left hip external rotation across two 2-minute walking trials
measure: Left Hip Range of Motion (transverse plane)
time frame: end of treatment (8 weeks from Baseline)
description: Mean peak degree of left hip external rotation across two 2-minute walking trials
measure: Right Hip Range of Motion (transverse plane)
time frame: Baseline
description: Mean peak degree of right hip external rotation across two 2-minute walking trials
measure: Right Hip Range of Motion (transverse plane)
time frame: end of treatment (8 weeks from Baseline)
description: Mean peak degree of right hip external rotation across two 2-minute walking trials
arm group label: Aerobic Exercise & Repetitive Task Practice
arm group type: Active Comparator
description: Participants will perform the following:
45 minutes of cycling
45 minutes of upper extremity repetitive arm exercises
arm group label: Upper Extremity Repetitive Task Practice Only
arm group type: Active Comparator
description: Participants will perform the following:
1. 90 minutes of upper extremity repetitive arm exercises
intervention type: Behavioral
intervention name: Aerobic Exercise
description: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
arm group label: Aerobic Exercise & Repetitive Task Practice
intervention type: Behavioral
intervention name: Upper Extremity Repetitive Task Practice
description: Repetitive arm exercises
arm group label: Aerobic Exercise & Repetitive Task Practice
arm group label: Upper Extremity Repetitive Task Practice Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Susan Linder, DPT
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Susan Linder
investigator title: Project Scientist, Principle Investigator
mesh term: Stroke
mesh term: Nervous System Diseases
mesh term: Brain Diseases
mesh term: Central Nervous System Diseases
mesh term: Cerebrovascular Disorders
mesh term: Cardiovascular Diseases
mesh term: Vascular Diseases
sharing ipd: No
provided document: 