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Virtual Reality Device for Rehabilitation of Stroke Patients

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual Reality (VR)

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UAB Spain Rehabilitation Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Reality supported therapy

Arm Description

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).

Outcomes

Primary Outcome Measures

Change in Upper-limb and hand motor function

National Institutes of Health Stroke Scale (NIHSS)

Change in upper-limb and hand motor function

Motricity Index

Change in upper-limb and hand motor function

Action Research Arm Test

Change in upper-limb and hand motor function

Nine hole Peg test

Change in upper-limb and hand motor function

Fugl-Meyer Assessment

Change in upper-limb and hand motor function

Modified Rankin Scale (m-RS)

Secondary Outcome Measures

Change in cognitive function

Montreal Cognitive Assessment (MOCA)

Change in activities of daily living (ADL) and quality of life

Stroke Impact Scale (SIS)

Change in depression

Patient Health Questionnaire 9 (PHQ9)

Full Information

NCT ID

NCT04139980

First Posted

October 2, 2019

Last Updated

August 30, 2022

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT04139980

Brief Title

Virtual Reality Device for Rehabilitation of Stroke Patients

Official Title

Virtual Reality Device for Rehabilitation of Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

March 3, 2020 (Actual)

Study Completion Date

March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual Reality supported therapy

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Virtual Reality (VR)

Other Intervention Name(s)

HTC Vive VR System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Upper-limb and hand motor function

Description

National Institutes of Health Stroke Scale (NIHSS)

Time Frame

Change from NIHSS measured at baseline visit, one week after final VR session, and three months following discharge. Totals are summed to determine the range:0= No stroke, 1-4 = Minor, 5-15 = Moderate, 15-20= Moderate to Severe; and 21-42 = Severe

Title

Change in upper-limb and hand motor function

Description

Motricity Index

Time Frame

Change from motricity index measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center

Title

Change in upper-limb and hand motor function

Description

Action Research Arm Test

Time Frame

Change from Action Research Arm Test measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center

Title

Change in upper-limb and hand motor function

Description

Nine hole Peg test

Time Frame

Change from Nine hole Peg test measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center

Title

Change in upper-limb and hand motor function

Description

Fugl-Meyer Assessment

Time Frame

Change from Fugl-Meyer Assessment measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center

Title

Change in upper-limb and hand motor function

Description

Modified Rankin Scale (m-RS)

Time Frame

Change from m-RS measured at baseline, one wee following final VR session, and three months following discharge. The score is based on symptoms with a 0 provided for no symptoms up to a 5 provided for severe disability; bedridden, requires constant care.

Secondary Outcome Measure Information:

Title

Change in cognitive function

Description

Montreal Cognitive Assessment (MOCA)

Time Frame

Change from MOCA measured at baseline, one week following final VR session, and three months following discharge. The scores are summed. The range is: 27-30=Normal; 18-26=Mild impairment; 10-17=Moderate impairment; <10=Severe

Title

Change in activities of daily living (ADL) and quality of life

Description

Stroke Impact Scale (SIS)

Time Frame

Change in SIS measured at baseline, one week after final VR session, and three months after discharge. Range is 0-100. Higher scores indicate better ADL and quality of life. Formula: Actual raw score - lowest possible score/Possible raw score)*100

Title

Change in depression

Description

Patient Health Questionnaire 9 (PHQ9)

Time Frame

Change from PHQ9 measured at baseline, one week following final VR session, and three months following discharge. Scores are totaled with higher score being severe. 5-9 = Mild, 10-14 = Moderate, 15-19 = Moderately severe, 20-27 = Severe

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chen Lin, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAB Spain Rehabilitation Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Virtual Reality Device for Rehabilitation of Stroke Patients

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