Recruiting

Constraint Induced Movement Therapy

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT03264261

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

robotic training

treadmill training

Study Details

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.

Conditions

Stroke

Study ID

NCT03264261

Start date

Aug 14, 2017

Status verified date

May, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Jul 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: robotic training

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.

active comparator: treadmill 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.

Interventions

robotic training

robotic training, 3 times/week for 6 weeks

treadmill training

treadmill training only, 3 times/week for 6 weeks

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Weena Dee, PT

312-238-7503wdee@ric.org

Locations

Abilitylab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Weena Dee, PT

312-238-7503wdee@sralab.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Jun 3, 2025

Last verified

May, 2025

Keywords

  • stroke, locomotion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2025-06-03.