Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: robotic training; Device: treadmill training

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weena Dee, PT; Phone Number: 312-238-7503; Email: wdee@ric.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Abilitylab
      • Contact: Weena Dee, PT; Phone Number: 312-238-7503; Email: wdee@sralab.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: robotic training; robotic training, 3 times/week for 6 weeks
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.	Device: treadmill training; treadmill training only, 3 times/week for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Berg Balance Scale	Berg Balance Scale scores will be collected by research physical therapist	pre, post 6 weeks training, and 8 weeks after the end of training.

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Investigators: Principal Investigator: Ming Wu, PhD, Abilitylab

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 24, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: stroke, locomotion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: R01HD082216 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes