N/A
N=9
Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02331407 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance — -16.31 unitless
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Robotic arm therapy (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance |
-16.31 | — |
| SECONDARY Fugl-Meyer (FM) Upper Extremity Motor Assessment |
30.3; 32.8; 36.0; 38.3 | — |
| SECONDARY Action Research Arm Test |
19.6; 21.3; 23.7; 25.0 | — |
Summary
Stroke is a leading cause of neurological disability worldwide, often causing significant weakening and paresis of the affected arm. National spending on post-stroke rehabilitation is project to expand 20% to 35% through 2010. As a new tool for therapists, robotic stroke therapy devices have the potential to be a cost-effective device aid to physical therapy and enable novel modes of exercise not currently available. While recent studies have shown chronic patients benefit from repetitive practice, it is not clear whether they improved via a reduction in impairment or increased functional compensation because there is a lack of standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients. This study aims to reconcile difference performance measurements in robotic rehabilitation to assess the outcome of robotic rehabilitation training.
Eligibility Criteria
Inclusion Criteria
- Hemiparesis of the upper extremity
- Diagnosis of a first clinically apparent ischemic stroke at least 6 months prior to study entry
- Age 18 years or older
- Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory disturbances and/or pain.
Exclusion Criteria
- Inability to understand and/or follow instructions
- Pain in shoulder or arm
- Other neurological or musculoskeletal target organ disorder
- Inability to give informed consent personally
- Previous or current contracture of the upper extremity
Data sourced from ClinicalTrials.gov (NCT02331407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.