A Phase 2 interventional study of rehabilitation robotics and Movement therapy in Stroke, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2012-10-30.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Phase 2, Interventional, and Treatment
We will test on persons with chronic impairment due to stroke:
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 190 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be included in the study if they meet the following criteria:
Exclusion Criteria:
Patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.
Device: rehabilitation robotics · Procedure: Movement therapy
Device: rehabilitation robotics · Procedure: Movement therapy
Device: rehabilitation robotics · Procedure: Movement therapy
Device: rehabilitation robotics · Procedure: Movement therapy
sequence of intervention
Also known as: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
sequence of intervention
Also known as: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
Fugl-Meyer
Time frame: 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
Wolf Motor Function
Time frame: 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
This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)