Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

• Sponsor: Shirley Ryan AbilityLab (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03264261
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: robotic training; Device: treadmill training	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
• Actual Study Start Date: Aug 14, 2017
• Anticipated Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Aug 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in walking speed [pre, post 6 weeks training, and 8 weeks after the end of training.]

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

2. Change in 6-minute walking distance [pre, post 6 weeks training, and 8 weeks after the end of training.]

   walking distance covered by subjects in 6 minutes

Secondary Outcome Measures

1. Change in Berg Balance Scale [pre, post 6 weeks training, and 8 weeks after the end of training.]

   Berg Balance Scale scores will be collected by research physical therapist

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abilitylab	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Shirley Ryan AbilityLab

Investigators

• Principal Investigator: Ming Wu, PhD, Abilitylab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ming Wu, Research Scientist, Shirley Ryan AbilityLab
• ClinicalTrials.gov Identifier: NCT03264261
• Other Study ID Numbers: R01HD082216
• First Posted: Aug 29, 2017
• Last Update Posted: May 4, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Ming Wu, Research Scientist, Shirley Ryan AbilityLab: stroke, locomotion
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of May 4, 2022