Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

NCT03264261 | Recruiting DMC FDA Device

• 1 other identifier: R01HD082216
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

stroke, locomotion

Outcome Measures

Primary Outcomes (2)

• Change in walking speed

  Overground gait speed will be collected on a 10 m instrumented walkway

  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

  pre, post 6 weeks training, and 8 weeks after the end of training.

Secondary Outcomes (1)

• Change in Berg Balance Scale

  pre, post 6 weeks training, and 8 weeks after the end of training.

Study Arms (2)

robotic training

EXPERIMENTAL

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

treadmill training

ACTIVE COMPARATOR

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

Interventions

robotic training DEVICE

robotic training, 3 times/week for 6 weeks

robotic training

treadmill training DEVICE

treadmill training only, 3 times/week for 6 weeks

treadmill training

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Abilitylab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ming Wu, PhD

  Abilitylab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weena Dee, PT

CONTACT

312-238-7503; wdee@ric.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures of each subject will be evaluated before training, after 6 weeks of training, and at 8 weeks after the end of training by a physical therapist who is blinded by subject group assignment, and subjects will be requested not to disclose his/her group assignment to this physical therapist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 29, 2017
• Study Start: August 14, 2017
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)