N/A
N=20
Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03559829 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Device Use — 27 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RAPAEL Smart Glove (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Use |
27 | — |
| SECONDARY Device Use Daily Average Per Use Day |
27 | — |
| SECONDARY Device Use Daily Average |
16.0 | — |
| SECONDARY Jebsen-Taylor Hand Function Test - Overall Score |
353 | 0.025 sig |
| SECONDARY Jebsen-Taylor Hand Function Test - Fine Score |
217 | 0.01 sig |
| SECONDARY Jebsen-Taylor Hand Function Test - Gross Score |
135 | 0.3 |
| SECONDARY Fugl-Meyer Assessment |
43 | 0.098 |
| SECONDARY Manual Muscle Testing (MMT) Score |
10.0 | 0.2 |
| SECONDARY Stroke Impact Scale (SIS) |
71 | 0.07 |
| SECONDARY Patient Experience |
4.38 | — |
Summary
Regaining upper extremity function is very important for stroke survivors to increase their independence and ability to perform activities of daily living (ADLs). Outpatient stroke rehabilitation currently takes place in a therapy clinic, however access can be limited by financial resources and transportation difficulties.
The Feasibility of Home-Based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke Study seeks to explore the safety, usability, and efficacy of a home based virtual reality biofeedback system to promote distal upper extremity (wrist and hand) recovery after stroke. The purpose of the study is to assess the feasibility of using a home-based virtual reality system to increase the dose of upper extremity rehabilitation in subacute and chronic stroke patients.
Eligibility Criteria
Inclusion Criteria
- 1) Age 18 and older 2) Diagnosis of stroke at least three months prior to enrollment 3) Unilateral upper extremity functional deficit after stroke 4) Presence of a score of at least 2 points on the medical research council scale for wrist flexion/extension or forearm pronation/supination 5) Able to provide informed consent 6) Caregiver who is willing to be trained in use of the Smart Glove
Exclusion Criteria
- 1) Predisposing psychological disorders which could impede participation 2) Severe aphasia resulting in communication difficulties 3) Severe pain impeding upper extremity rehabilitation 4) Pre-existing neurological disorder that causes motor deficits (i.e. Parkinson's disease)
Data sourced from ClinicalTrials.gov (NCT03559829). 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.