Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
- Conditions
- Stroke
- Interventions
- Device: robotic trainingDevice: treadmill training
- Registration Number
- NCT03264261
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description robotic training 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. treadmill training 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.
- Primary Outcome Measures
Name Time Method Change in walking speed 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
Change in 6-minute walking distance pre, post 6 weeks training, and 8 weeks after the end of training. walking distance covered by subjects in 6 minutes
- Secondary Outcome Measures
Name Time Method Change in Berg Balance Scale pre, post 6 weeks training, and 8 weeks after the end of training. Berg Balance Scale scores will be collected by research physical therapist
Trial Locations
- Locations (1)
Abilitylab
🇺🇸Chicago, Illinois, United States