Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke

NCT03559829 | Completed Results FDA Device

• 2 other identifiers: 37580125802
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Device Use

  Number of days during 8 week study-period that patient used the device.

  8 weeks

Secondary Outcomes (9)

• Device Use Daily Average Per Use Day

  8 weeks

• Device Use Daily Average

  8 weeks

• Jebsen-Taylor Hand Function Test - Overall Score

  8 weeks

• Jebsen-Taylor Hand Function Test - Fine Score

  8 weeks

• Jebsen-Taylor Hand Function Test - Gross Score

  8 weeks

Study Arms (1)

Single Arm - Intervention arm

EXPERIMENTAL

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.

Device: RAPAEL Smart Glove

Interventions

RAPAEL Smart Glove DEVICE

The RAPAEL Smart Glove is a commercially available, non-invasive biofeedback based system for distal upper extremity rehabilitation. The Smart Glove is very lightweight and allows for easy movement of all distal upper extremity joints. It is made of an elastomer material that is simple to maintain and clean. The Bending Sensor is a variable resistor that changes as it is bent. The sensor is a 9-axis movement and position sensor that consists of 3 acceleration channels, 3 angular rate channels, and 3 magnetic field channels that measure wrist movements. They are connected to a computer system which can accurately compute the amount of individual finger movements.

Single Arm - Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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)

Sponsors & Collaborators

• Stanford University: lead
• NEOFECT Rehabilitation Solutions: collaborator

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 33773059 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Maarten G. Lansberg, MD PhD
• Organization: Associate Professor of Neurology and Neurological Sciences

lansberg@stanford.edu

(650) 723-4448

Study Officials

• Kara Flavin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Maarten Lansberg, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neurology

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 18, 2018
• Study Start: September 23, 2016
• Primary Completion: February 2, 2018
• Study Completion: February 2, 2018
• Last Updated: May 1, 2019
• Results First Posted: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)