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Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03264261
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Ming Wu, Shirley Ryan AbilityLab

Brief Summary:
To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated. Data collection will proceed until 36 subjects from 2 groups have been trained.

Condition or disease Intervention/treatment Phase
Stroke Device: robotic training Device: treadmill training Not Applicable

Detailed Description:
To determine the effect of constraint induced movement therapy (CIMT) on locomotor function in individuals post stroke. In order to compare the effect of CIMT vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be blocked by gait speed into slow (< 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated, excluding set up time. Data collection will proceed until 36 subjects from 2 groups have been trained.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be blocked by gait speed into slow (< 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the CIMT or treadmill training only groups at the initial test.
Masking: Single (Outcomes Assessor)
Masking Description: Outcome measures of each subject will be evaluated before training, after 6 weeks of training, and at 8 weeks after the end of training by a physical therapist who is blinded by subject group assignment, and subjects will be requested not to disclose his/her group assignment to this physical therapist.
Primary Purpose: Treatment
Official Title: Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Arm Intervention/treatment
Experimental: robotic training
For the robotic training group, a controlled resistance load will be applied to the unaffected leg at the ankle and an assistance load will be applied to the pelvis.
Device: robotic training
robotic training, 3 times/week for 6 weeks

Active Comparator: treadmill training
For the treadmill training only group, a physical therapist will provide manual assistance to the affected leg at the knee and/or ankle joints as necessary during treadmill training.
Device: treadmill training
treadmill training only, 3 times/week for 6 weeks




Primary Outcome Measures :
  1. Change in walking speed [ Time Frame: pre, post 6 weeks training, and 8 weeks after the end of training. ]
    Overground gait speed will be collected on a 10 m instrumented walkway

  2. Change in 6-minute walking distance [ Time Frame: pre, post 6 weeks training, and 8 weeks after the end of training. ]
    walking distance covered by subjects in 6 minutes


Secondary Outcome Measures :
  1. Change in Berg Balance Scale [ Time Frame: pre, post 6 weeks training, and 8 weeks after the end of training. ]
    Berg Balance Scale scores will be collected by research physical therapist



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age between 21 and 75 years;
  2. history of unilateral, supratentorial, ischemic or hemorrhagic stroke;
  3. no prior stroke;
  4. demonstration of impaired walking function (self-selected walking speed ≤ 0.80 m/s);
  5. able to stand and walk (>10 meters) without physical assistance.

Exclusion Criteria:

  1. significant cardiorespiratory/metabolic disease;
  2. other neurological or orthopedic injury that impairs locomotion;
  3. scores on the Mini Mental Status examination < 24;
  4. stroke of the brainstem or cerebellar lesions;
  5. uncontrolled hypertension (systolic > 200 mm Hg, diastolic > 110 mm Hg);
  6. botox injection within 6 months of starting the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264261


Contacts
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Contact: Weena Dee, PT 312-238-7503 wdee@ric.org

Locations
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United States, Illinois
Abilitylab Recruiting
Chicago, Illinois, United States, 60611
Contact: Weena Dee, PT    312-238-7503    wdee@sralab.org   
Sponsors and Collaborators
Shirley Ryan AbilityLab
Investigators
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Principal Investigator: Ming Wu, PhD Abilitylab
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Responsible Party: Ming Wu, Research Scientist, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT03264261    
Other Study ID Numbers: R01HD082216 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Ming Wu, Shirley Ryan AbilityLab:
stroke, locomotion
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases