Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

Stroke Clinical Trial

Official title:

Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264261
• Other study ID #: R01HD082216
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: October 30, 2024

Study information

• Verified date: March 2023
• Source: Shirley Ryan AbilityLab
• Contact: Weena Dee, PT
• Phone: 312-238-7503
• Email: wdee[@]ric.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• robotic training
robotic training, 3 times/week for 6 weeks
• treadmill training
treadmill training only, 3 times/week for 6 weeks

Locations

Country	Name	City	State
United States	Abilitylab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.