Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: robotic training, treadmill training.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 21 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device robotic training
robotic training, 3 times/week for 6 weeks - Device treadmill training
treadmill training only, 3 times/week for 6 weeks
Primary outcome measures
- Change in walking speed [Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.]
- Change in 6-minute walking distance [Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.]
Secondary outcome measures (1)
- Change in Berg Balance Scale [Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Abilitylab — Chicago
Identifiers
NCT: NCT03264261 · R01HD082216