An interventional study of robotic training and treadmill training in Stroke, sponsored by Shirley Ryan AbilityLab. Recruiting at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
robotic training, 3 times/week for 6 weeks
treadmill training only, 3 times/week for 6 weeks
Change in walking speed
Overground gait speed will be collected on a 10 m instrumented walkway
Time frame: 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
Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.
Change in Berg Balance Scale
Berg Balance Scale scores will be collected by research physical therapist
Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.
Plan to share: No
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Shirley Ryan AbilityLab