Clinical trial NCT00453843: Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?
Official title: The Effect of Proximal and Distal Training on Stroke Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Stroke
movement therapy
robotics
rehabilitation robotics
shoulder, elbow, wrist
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: Burke Medical Research Institute
First posted: 2007-03-29
Enrollment: 190
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will test on persons with chronic impairment due to stroke:

1. whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
2. whether we should train the shoulder, elbow, and wrist at the same time or on different days.

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.

Eligibility criteria: Inclusion Criteria:

Patients will be included in the study if they meet the following criteria:

1. naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients;
2. first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that has occurred at least 6 months prior;
3. cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects);
4. 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);
5. 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.

Primary outcomes:
measure: Fugl-Meyer
timeFrame: 3 times at baseline, midpoint, completion intervention, and at follow-up
measure: Motor Power
timeFrame: 3 times at baseline, midpoint, completion intervention, and at follow-up
Secondary outcomes:
measure: Wolf Motor Function
timeFrame: 3 times at baseline, midpoint, completion intervention, and at follow-up
measure: SIS
timeFrame: 3 times at baseline, midpoint, completion intervention, and at follow-up
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Medical Research Institute
state: New York
Study officials:
affiliation: Massachusetts Institute of Technology
name: Hermano I Krebs, PhD
role: PRINCIPAL_INVESTIGATOR
References: