N/A
N=14
Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis
Cerebrovascular Accident
Bottom Line
View on ClinicalTrials.gov: NCT00125658 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Change in Trunk Displacement — 3.79; -3.62; 0.66; -4.76 centimeters — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Control (Other); Experimental (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Trunk Displacement |
3.79; -3.62; 0.66; -4.76 | <.001 sig |
| PRIMARY Change in Shoulder Flexion |
-2.42; 11.88; -1.61; 10.37 | 0.13 |
| PRIMARY Change in Elbow Extension Range of Motion |
-8.83; 22.52; -5.62; 26.20 | .004 sig |
| PRIMARY Upper-extremity Fugl-Meyer Motor Assessment |
7.0; 6.7; 10.14; 9.00 | 0.564 |
| SECONDARY Movement Speed |
3.86; -2.67; 1.46; 7.15 | 0.056 |
| SECONDARY Movement Accuracy (Reach Path Ratio, RPR) |
-0.22; -1.82; -0.85; -1.59 | 0.078 |
| SECONDARY Movement Smoothness |
0.71; -2.79; -1.64; -2.71 | 0.085 |
Summary
The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of cerebrovascular accident
- Single event
- Unilateral hemiplegia
- Between 6 months and 18 months post-event
- Impairment of upper-extremity function
- Ability to produce partial range of motion out of plane of gravity at shoulder, elbow, and wrist
- At least 10 degrees of wrist motion (any 10 degrees), and finger flexion/extension in 2 fingers
- Cognitive ability to follow 3-step commands
Exclusion Criteria
- Unstable or uncontrolled blood pressure
- Uncontrolled seizures
- Flaccid hemiplegia
- Severe cognitive impairment
Data sourced from ClinicalTrials.gov (NCT00125658). 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.