Virtual Reality Device for Rehabilitation of Stroke Patients

NCT ID: NCT04139980

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-03-03

Brief Summary

This study will evaluate the potential efficacy and safety of using virtual reality gaming in conjunction to standard therapy regimen care as an approach to promote upper-limb motor recovery, cognitive function and quality of life after stroke. The investigators believe that allowing users to interact with a computer-simulated reality environment will result in a pleasant experience, which will likely result in motivation and therapy engagement.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality supported therapy

The Virtual Reality (VR) interface will be used during patients stay at the rehabilitation center. A research employee will install the VR system in the patient's room. Participants will be comfortable sitting while in VR session. Each interface consists of a head mounted display (HMD) allowing participants to see their arms and legs represented in the virtual environment. Participants will be able to control their virtual legs using hand controllers, which will allow them to "walk" through several virtual environments and gather "points" (no additional gaming elements are included).

Group Type: EXPERIMENTAL

Virtual Reality (VR)

Intervention Type: OTHER

Each VR session is 30 minutes long. Participants are able to pause or discontinue at any time. Each participant will receive one VR sessions five times per week over the course of a two-week period.

Interventions

Virtual Reality (VR)

Each VR session is 30 minutes long. Participants are able to pause or discontinue at any time. Each participant will receive one VR sessions five times per week over the course of a two-week period.

Intervention Type: OTHER

Other Intervention Names

HTC Vive VR System

Eligibility Criteria

Inclusion Criteria

• Patient admitted to the UAB Hospital, older than 18 years old, with a diagnosis of stroke
• Patient with unilateral upper extremity weakness
• Patients that after evaluation by Physical and Occupational professionals were admitted to rehabilitation facility "Spain Rehabilitation Center".

Exclusion Criteria

• Patients with severe cognitive impairment
• Patient with orthopedic impairment (i.e. marked arthritis)
• Patient with visual disorders limiting therapy session
• Those for whom voluntary arm movement would cause sufficient discomfort (>4/10) that could prevent trial completion will be excluded from participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Chen Lin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen Lin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Spain Rehabilitation Center

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300003889

Identifier Type: -

Identifier Source: org_study_id