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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728866
• Other study ID #: HM20025720
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Virginia Commonwealth University
• Contact: Rahsaan Holley
• Phone: 804-828-1564
• Email: holleyrj[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• VR immersive therapy
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to approximately 12 days