Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Device Use
Study Overview
Brief 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.
Detailed Description
In this pilot study, we propose to test a virtual reality home-based intervention as an alternative or supplement to traditional rehabilitation for upper extremity weakness after stroke. We are hoping to discover that the device is easily adopted by patients and increases the dose of rehabilitation, as well as potentially leads to motor recovery.
With the increasing affordability and accessibility of virtual reality (VR) systems, VR has emerged as a new platform for stroke rehabilitation. VR therapy involves using computer-based programs to simulate daily tasks and events. VR has shown promise in both allowing patients to practice activities that directly translate to their ADLs, as well as motivating them by providing a novel and interesting virtual environment.
Relevance Regaining upper extremity function is very important for stroke survivors to increase their independence and ability to perform ADLs. The large majority of outpatient stroke rehabilitation currently takes place in a therapy clinic, however access is often limited by resource allocation, financial hardship, and transportation difficulties. The Smart Glove can provide an inexpensive and convenient means for stroke patients to continue their rehabilitation in the comfort of their own home.
Patient Population Subacute and chronic stroke patients presenting with upper extremity weakness, as identified by Stanford physicians in clinic, will be eligible for participation in this study. Patients will be screened and selected from the population of people with strokes who are seen in the Stanford Neuroscience Clinic. Patients will be allowed to participate in any scheduled outpatient rehabilitation during the study. The doctor and/or research coordinator may introduce the study to potential candidates in-person in the Stanford Neurology Clinic, and the research coordinator may contact potential candidates by phone after the doctor's referral.
Procedures:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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)
Arms & Interventions
Single Arm - Intervention arm
RAPAEL Smart Glove Arm The participant will be issued a Smart Glove and a tablet preloaded with the game software. The available games provide various kinds of motion tasks such as ADL-related tasks presented in an entertaining manner. The learning schedule algorithm automatically adjusts to the optimal level of difficulty to balance challenge and motivation. The participant will be expected to use the Smart Glove at home for 60 min per day for at least 5 days per week.
Intervention: RAPAEL Smart Glove (Device)
Outcomes
Primary Outcomes
Device Use
Time Frame: 8 weeks
Number of days during 8 week study-period that patient used the device.
Secondary Outcomes
- Fugl-Meyer Assessment(8 weeks)
- Manual Muscle Testing (MMT) Score(8 weeks)
- Jebsen-Taylor Hand Function Test - Overall Score(8 weeks)
- Jebsen-Taylor Hand Function Test - Fine Score(8 weeks)
- Device Use Daily Average(8 weeks)
- Jebsen-Taylor Hand Function Test - Gross Score(8 weeks)
- Stroke Impact Scale (SIS)(8 weeks)
- Patient Experience(8 weeks)
- Device Use Daily Average Per Use Day(8 weeks)
Investigators
Maarten Lansberg
Associate Professor, Neurology
Stanford University