Stroke
Conditions
Keywords
stroke, locomotion
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.
Interventions
DEVICErobotic training
robotic training, 3 times/week for 6 weeks
DEVICEtreadmill training
treadmill training only, 3 times/week for 6 weeks
Sponsors
Shirley Ryan AbilityLab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactWeena Dee, PT
Outcome results
None listed