NCT03264261 · Shirley Ryan AbilityLab
Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
What this study is about
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, randomly assigned training study will be conducted with three assessments of gait to determine the training effect. Subjects will be randomly assigned to either the CIMT or treadmill training only groups at the initial test.
View original scientific description
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.
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.
Overground gait speed will be collected on a 10 m instrumented walkway
Change in 6-minute walking distance
Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.
walking distance covered by subjects in 6 minutes
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2025 · Source of record for eligibility and locations