Phase 3
Completed N=67
Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Cerebrovascular Disorders · Hemiplegia
Source: ClinicalTrials.gov NCT00223808 ↗
Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Fugl-Meyer Score Change Immediately Following Study Intervention. — 6.8; 14.4; 14.0 units on a scale
Summary
The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Score Change Immediately Following Study Intervention. |
6.8; 14.4; 14.0 | — |
| PRIMARY Fugl-Meyer Score Change at 6 Months |
15.9; 23.6; 15.3 | — |
| SECONDARY Change in FIM Score Immediately Following Study Intervention. |
17.7; 21.5; 15.9 | — |
| SECONDARY Change in FIM Score at 6-months |
24.2; 27.5; 26.8 | — |
Eligibility Criteria
Inclusion Criteria
- Over 21 years of age, weakness due to a recent stroke or other brain injury, and receiving rehabilitation. Subjects are inpatients at one of the participating VA hospitals.
Exclusion Criteria
Unable to follow instructions; medically unstable.
Data sourced from ClinicalTrials.gov (NCT00223808). 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. Informational only — not medical advice.