Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
robotic training
treadmill training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, locomotion
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- AbilitylabRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
robotic training
treadmill training
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in walking speed
Overground gait speed will be collected on a 10 m instrumented walkway
Change in 6-minute walking distance
walking distance covered by subjects in 6 minutes
Secondary Outcome Measures
Change in Berg Balance Scale
Berg Balance Scale scores will be collected by research physical therapist
Full Information
NCT ID
NCT03264261
First Posted
August 14, 2017
Last Updated
March 10, 2023
Sponsor
Shirley Ryan AbilityLab
1. Study Identification
Unique Protocol Identification Number
NCT03264261
Brief Title
Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
Official Title
Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, locomotion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
robotic training
Arm Type
Experimental
Arm 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.
Arm Title
treadmill training
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
robotic training
Intervention Description
robotic training, 3 times/week for 6 weeks
Intervention Type
Device
Intervention Name(s)
treadmill training
Intervention Description
treadmill training only, 3 times/week for 6 weeks
Primary Outcome Measure Information:
Title
Change in walking speed
Description
Overground gait speed will be collected on a 10 m instrumented walkway
Time Frame
pre, post 6 weeks training, and 8 weeks after the end of training.
Title
Change in 6-minute walking distance
Description
walking distance covered by subjects in 6 minutes
Time Frame
pre, post 6 weeks training, and 8 weeks after the end of training.
Secondary Outcome Measure Information:
Title
Change in Berg Balance Scale
Description
Berg Balance Scale scores will be collected by research physical therapist
Time Frame
pre, post 6 weeks training, and 8 weeks after the end of training.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weena Dee, PT
Phone
312-238-7503
Email
wdee@ric.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Wu, PhD
Organizational Affiliation
Abilitylab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abilitylab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weena Dee, PT
Phone
312-238-7503
Email
wdee@sralab.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
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