Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?
The Effect of Proximal and Distal Training on Stroke Recovery
We will test on persons with chronic impairment due to stroke:
- whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
- whether we should train the shoulder, elbow, and wrist at the same time or on different days.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Effect of Proximal and Distal Training on Stroke Recovery:
Specific Aim 1. Test whether task specific wrist robotic training improves motor performance among persons with chronic impairment after stroke.
Specific Aim 2. Test whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
Specific Aim 3. Test whether there is generalization across different joints (shoulder & elbow vs wrist).
Specific Aim 4: Test whether there is any interference between training across different joints among persons with chronic impairment after stroke.
Briefly we will invite persons with chronic impairment due to stroke to participate in a study that will train them first on wrist for 6 weeks and then on the shoulder-and-elbow for an additional 6 weeks or vice-versa. A third group will train in alternate days for 12 weeks on the shoulder-and-elbow or the wrist, while a fourth group will be trained on the shoulder, elbow, and wrist on the same day. Outcomes will be measured using standard instruments as well as robot-based measures. We expect that results from this study will provide an objective basis for maximizing this kind of therapy.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
White Plains, New York, United States, 10605
- Burke Medical Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients will be included in the study if they meet the following criteria:
- naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients;
- first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that has occurred at least 6 months prior;
- cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects);
- average Motor Power score >= 1/5 or <= 3/5 (neither hemiplegic nor fully recovered motor function in 6 muscles of the shoulder, elbow, and wrist);
- informed written consent to participate in the study.
Exclusion Criteria:
Patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: proximal to distal training
|
sequence of intervention
Other Names:
sequence of intervention
Other Names:
|
|
Experimental: distal to proximal
|
sequence of intervention
Other Names:
sequence of intervention
Other Names:
|
|
Experimental: proximal and distal on alternate days
|
sequence of intervention
Other Names:
sequence of intervention
Other Names:
|
|
Experimental: proximal and distal same day
|
sequence of intervention
Other Names:
sequence of intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fugl-Meyer
Time Frame: 3 times at baseline, midpoint, completion intervention, and at follow-up
|
3 times at baseline, midpoint, completion intervention, and at follow-up
|
|
Motor Power
Time Frame: 3 times at baseline, midpoint, completion intervention, and at follow-up
|
3 times at baseline, midpoint, completion intervention, and at follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Wolf Motor Function
Time Frame: 3 times at baseline, midpoint, completion intervention, and at follow-up
|
3 times at baseline, midpoint, completion intervention, and at follow-up
|
|
SIS
Time Frame: 3 times at baseline, midpoint, completion intervention, and at follow-up
|
3 times at baseline, midpoint, completion intervention, and at follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hermano I Krebs, PhD, Massachusetts Institute of Technology
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HD045343 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.