Phase 2
N=41
Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01244243 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Action Research Arm Test — 4.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hand & Wrist Assisting Robotic Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Action Research Arm Test |
4.1 | — |
| PRIMARY Arm Motor Fugl-Meyer Test |
3.7 | — |
Summary
The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- Had stroke between 11-26 weeks ago
- Have some weakness in one of your wrists or hands due to stroke
- Did not have too much disability prior to stroke
- Do not have major depression
Exclusion Criteria
- Non-English speaking
- If you have trouble keeping good attention
- Pregnant, advanced liver, kidney, heart, or lung disease
- Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
- Cannot undergo MRI scanning
- Have history of brain surgery or seizures
Data sourced from ClinicalTrials.gov (NCT01244243). 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.