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Effectiveness of Immersive Virtual Reality Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke: A Single Case Series Study.

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR immersive therapy
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

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: Age 18 or older. Diagnosed as having an ischemic or hemorrhagic stroke (with documented confirmatory neuroimaging in the medical record) that occurred at least 6-months prior to study enrollment. Lack of full active range of motion in the involved shoulder, elbow, and wrist as the result of the injury. At the time of study enrollment, participant completed structured therapeutic interventions at least 2-months prior. Participants will not participate in Yoga, Tai-Chi, or other wellness lifestyle classes while participating in the study. Absence of significant cognitive impairment as determined by a Mini-Mental Status Examination score of greater than or equal to 24. The absence of upper extremity injury limiting functional use of the arm prior to the incident stroke. Exclusion Criteria: Unable to provide informed consent. Sensory loss as determined by a score of 2 on the sensory item of the NIH Stroke Scale. Pain in the involved upper limb that could interfere with daily activities as evidenced by a pain score of 5 or greater on the Numeric Pain Rating Scale. History of greater than two strokes. Suffered a stroke less than 6-months prior to participating in the study. A history of, or being susceptible to, cyber-sickness (i.e., motion sickness). Unable to don/doff accelerometer independently, or the lack of support in the home to assist with donning/doffing device; and A history of seizures.

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual reality (VR) therapy

Arm Description

Outcomes

Primary Outcome Measures

Change in hemiplegic arm movements
Arm movements will be measured using wrist-worn accelerometers. Amount of movement will be measured prior to and following the intervention

Secondary Outcome Measures

Full Information

First Posted
February 6, 2023
Last Updated
September 18, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT05728866
Brief Title
Effectiveness of Immersive Virtual Reality Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke: A Single Case Series Study.
Official Title
Effectiveness of Immersive Virtual Reality Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke: A Single Case Series Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this research study is to understand the efficacy of using an immersive Virtual Reality (VR) environment, with task-specific training, to encourage arm movement following stroke.
Detailed Description
The study will investigate how people who have had a stroke use their weakened arm in everyday tasks, and how this relates to measurements of movement ability from standardized clinic tests. Results of this research will ultimately help develop more effective training approaches to be used with stroke survivors.

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
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality (VR) therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
VR immersive therapy
Intervention Description
Participants will be asked to participate in 5 consecutive, 1-hour, 1:1 therapy sessions focused on rehabilitation of their weakened arm. Each session will involve use of a Virtual Reality (VR) system to deliver an immersive environment to encourage movement of the arm. The system also relies on 6 body-worn sensors that will detect movements of participant's arms and trunk. VR use will encompass 30-minutes of the therapy session, the remainder of the session will involve working with the therapist in addressing the functional tasks that are most meaningful for the participant and that involve the upper extremities.
Primary Outcome Measure Information:
Title
Change in hemiplegic arm movements
Description
Arm movements will be measured using wrist-worn accelerometers. Amount of movement will be measured prior to and following the intervention
Time Frame
Baseline to approximately 12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older. Diagnosed as having an ischemic or hemorrhagic stroke (with documented confirmatory neuroimaging in the medical record) that occurred at least 6-months prior to study enrollment. Lack of full active range of motion in the involved shoulder, elbow, and wrist as the result of the injury. At the time of study enrollment, participant completed structured therapeutic interventions at least 2-months prior. Participants will not participate in Yoga, Tai-Chi, or other wellness lifestyle classes while participating in the study. Absence of significant cognitive impairment as determined by a Mini-Mental Status Examination score of greater than or equal to 24. The absence of upper extremity injury limiting functional use of the arm prior to the incident stroke. Exclusion Criteria: Unable to provide informed consent. Sensory loss as determined by a score of 2 on the sensory item of the NIH Stroke Scale. Pain in the involved upper limb that could interfere with daily activities as evidenced by a pain score of 5 or greater on the Numeric Pain Rating Scale. History of greater than two strokes. Suffered a stroke less than 6-months prior to participating in the study. A history of, or being susceptible to, cyber-sickness (i.e., motion sickness). Unable to don/doff accelerometer independently, or the lack of support in the home to assist with donning/doffing device; and A history of seizures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rahsaan Holley
Phone
804-828-1564
Email
holleyrj@vcu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Virginia Chu, PhD
Phone
804-828-1564
Email
vchu@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Chu, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Immersive Virtual Reality Combined With Task-Specific Training on Hemiplegic Arm Function Following Stroke: A Single Case Series Study.

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