What this study is
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.
What's being tested
- robotic training
Intervention · DEVICE
robotic training, 3 times/week for 6 weeks
- treadmill training
Intervention · DEVICE
treadmill training only, 3 times/week for 6 weeks
Study details
- Sponsor
- Shirley Ryan AbilityLab
- Conditions
- Stroke
- Enrolling
- 36 people
- Starts
- 2017-08-14
- Est. completion
- 2025-12-30
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 open- Recruiting
Study team
Sponsor
Shirley Ryan AbilityLab
Study ID R01HD082216
Principal investigator
Ming Wu, PhD
Abilitylab
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.