Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Stroke

Treatments: Device: robotic training; Device: treadmill training

Study type: Interventional

Funder types: Other

Identifiers

NCT03264261

R01HD082216

Details and patient eligibility

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, 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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

robotic training

Experimental group

Description:

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.

Treatment:

Device: robotic training

treadmill training

Active Comparator group

Description:

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.

Treatment:

Device: treadmill training