Stroke Clinical Trial
Official title:
Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke
Verified date | April 2019 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 2, 2018 |
Est. primary completion date | February 2, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Hospital and Clinics | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | NEOFECT Rehabilitation Solutions |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device Use | Number of days during 8 week study-period that patient used the device. | 8 weeks | |
Secondary | Device Use Daily Average Per Use Day | Daily average number of minutes of device-use per days that device was used. | 8 weeks | |
Secondary | Device Use Daily Average | Daily average number of minutes of device-use during 8-week intervention period. | 8 weeks | |
Secondary | Jebsen-Taylor Hand Function Test - Overall Score | Time (in seconds) to complete the total Jebsen-Taylor Hand Function Test administered at 8-weeks. The test consists of 7 subtests. Each subtest is allotted a maximum time of 90 seconds. The total score is the sum of the scores of the seven subtests. The total score has a maximum of 630 seconds and there is no minimum. Longer time to complete the test indicates worse hand function. | 8 weeks | |
Secondary | Jebsen-Taylor Hand Function Test - Fine Score | Time (in seconds) to complete the four fine-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks. Each of the four subtests is allotted a maximum time of 90 seconds. The total score is the sum of the scores of the four subtests. The total score has a maximum of 360 seconds and there is no minimum. Longer time to complete the test indicates worse hand function. | 8 weeks | |
Secondary | Jebsen-Taylor Hand Function Test - Gross Score | Time (in seconds) to complete the three gross-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks. Each of the three gross-motor subtests is allotted a maximum time of 90 seconds. The total gross-motor score is the sum of the scores of the three subtests. The total score has a maximum of 270 seconds and there is no minimum. Longer time to complete the test indicates worse hand function. | 8 weeks | |
Secondary | Fugl-Meyer Assessment | Upper Extremity Fugl-Meyer Test score at 8-weeks. Score ranges from 0 to 66, with higher scores corresponding to better arm function. | 8 weeks | |
Secondary | Manual Muscle Testing (MMT) Score | The MMT score is the sum of the Medical Research Council (MRC) scores across 5 domains (elbow flexor, elbow extensor, wrist extension, finger extension and finger flexion) at 8 weeks. Each domain has a scale range of 0 to 5, with higher scores corresponding to better strength. Maximum MMT score ranges from 0-25, with higher scores corresponding to better strength. | 8 weeks | |
Secondary | Stroke Impact Scale (SIS) | Score on the SIS at 8-weeks. The score ranges from 0 to 100, with higher scores corresponding to better recovery from stroke. | 8 weeks | |
Secondary | Patient Experience | Patient self-reported satisfaction with device use (5-point Likert Scale, with higher scores indicating greater satisfaction). | 8 weeks |
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