Clinical trial NCT03559829: Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke
Official title: Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: NEOFECT Rehabilitation Solutions
First posted: 2018-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

Once the participant has given informed consent and enrolled in the study, they will have a total of five visits, with one visit every two weeks.

Visit one will entail the participant and identified caregiver undergoing training on the use of the Smart Glove by the research coordinator and Neofect staff. This involves donning/doffing of the glove as well as instruction as to how to use the software program. The participant will be issued a Smart Glove and a tablet preloaded with the software. Subjects will also undergo baseline functional testing, including manual muscle testing (MMT), Fugl-Meyer assessment (FM), Jebsen-Taylor hand function test (JTT), and Stroke Impact Scale (SIS). This first visit is expected to take 60-90 minutes. The participant will be expected to use the Smart Glove for 60 min per day for at least 5 days per week.

The subsequent three visits will be at two week intervals and will involve the participant bringing the device to the Clinical and Translational Research Unit (CTRU). The research coordinator will upload the data from the device as well as troubleshoot any device-related issues. These visits will last 15-30 minutes each.

The final visit will occur after eight weeks of Smart Glove use. In addition to downloading the data, the research coordinator will also repeat functional testing functional testing, including manual muscle testing (MMT), Fugl-Meyer assessment (FM), Jebsen-Taylor hand function test (JTT), and Stroke Impact Scale (SIS). This visit will last 45-60 minutes.

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)

Primary outcomes:
measure: Device Use
timeFrame: 8 weeks
Secondary outcomes:
measure: Device Use Daily Average Per Use Day
timeFrame: 8 weeks
measure: Device Use Daily Average
timeFrame: 8 weeks
measure: Jebsen-Taylor Hand Function Test - Overall Score
timeFrame: 8 weeks
measure: Jebsen-Taylor Hand Function Test - Fine Score
timeFrame: 8 weeks
measure: Jebsen-Taylor Hand Function Test - Gross Score
timeFrame: 8 weeks
measure: Fugl-Meyer Assessment
timeFrame: 8 weeks
measure: Manual Muscle Testing (MMT) Score
timeFrame: 8 weeks
measure: Stroke Impact Scale (SIS)
timeFrame: 8 weeks
measure: Patient Experience
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Kara Flavin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Maarten Lansberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lansberg MG, Legault C, MacLellan A, Parikh A, Muccini J, Mlynash M, Kemp S, Buckwalter MS, Flavin K. Home-based virtual reality therapy for hand recovery after stroke. PM R. 2022 Mar;14(3):320-328. doi: 10.1002/pmrj.12598. Epub 2021 May 24.