Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: robotic training
* Device: treadmill training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 21 and 75 years; history of unilateral, supratentorial, ischemic or hemorrhagic stroke; no prior stroke; demonstration of impaired walking function (self-selected walking speed ≤ 0.80 m/s); able to stand and walk (>10 meters) without physical assistance. Exclusion Criteria: significant cardiorespiratory/metabolic disease; other neurological or orthopedic injury that impairs locomotion; scores on the Mini Mental Status examination < 24; stroke of the brainstem or cerebellar lesions; uncontrolled hypertension (systolic > 200 mm Hg, diastolic > 110 mm Hg); botox injection within 6 months of starting the study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robotic training<br>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<br>* robotic training, 3 times/week for 6 weeks<br>|
| Active Comparator: treadmill training<br>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<br>* treadmill training only, 3 times/week for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking speed | Overground gait speed will be collected on a 10 m instrumented walkway | pre, post 6 weeks training, and 8 weeks after the end of training. | 
| Change in 6-minute walking distance | walking distance covered by subjects in 6 minutes | pre, post 6 weeks training, and 8 weeks after the end of training. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Berg Balance Scale | Berg Balance Scale scores will be collected by research physical therapist | pre, post 6 weeks training, and 8 weeks after the end of training. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, locomotion