Effect of Upper Extremity Rehabilitation Using Immersive Virtual Reality in Chronic Stroke Patients.

Stroke Clinical Trial

Official title:

Effect of Upper Extremity Rehabilitation Using Fully-immersive Virtual Reality for Motor Recovery in Chronic Stroke Patients: A Prospective, Multicenter, Single-blind, Explorative, Randomized Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05148052
• Other study ID #: Stroke-VR-U/Ex
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Han Gil Seo, MD, PhD
• Phone: 82-2-2072-1659
• Email: hgseo80[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aimed to investigate the effect of exergames using virtual reality with head mounted device on motor recovery of upper extremities in chronic stroke patients.

Description:

This is a crossover study for comparing conventional occupational therapy and exercise with game format using virtual reality (virtual reality exergame). The virtual reality exergame is designed to maximize the movement of upper extremities, primary to the shoulder and elbow. Thirty-six chronic stroke patient will receive conventional occupational treatment and virtual reality exergame in random order with a two-week-washout period. Outcome measures will be evaluated within two days before and after each treatment, conventional treatment and virtual reality exergame.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Chronic stroke patients who have passed 6 months or more without additional stroke after the first stroke

• Patients with upper extremity dysfunction due to stroke (ischemic, hemorrhagic)

• Patients who can move the upper extremity against gravity with a manual muscle test of grade 3 or higher in the affected shoulder and elbow, respectively

• Patients who can stably maintain a sitting position

• Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

• Patients with moderate or severe cognitive impairment with a score of 18 or less on the Mini-Mental Status Examination (K-MMSE)

• Patients with other causes of upper extremity dysfunction, such as peripheral nerve damage, joint disease, etc.

• Patients with a history of severe vertigo or epilepsy

• Patients with medical reasons such as medical conditions that make it difficult to participate in research

• Patients who may be pregnant or who are pregnant or lactating

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Virtual reality exergames
Twelve sessions of virtual reality exergames involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.

Behavioral:
• Conventional occupational therapy
Conventional occupational therapy involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Korea Workers' Compensation & Welfare Service Incheon Hospital	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea Worker's Compensation and Welfare Service Incheon Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Korea Workers' Compensation and Welfare Service Incheon Hospital, National Traffic Injury Rehabilitation Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test	As an upper extremity function evaluation tool, it tests grasp, grip, pinch, and gross arm movement function as sub-tests.	Within 2 days after the end of each intervention
Secondary	Box and Block test	an upper extremity function evaluation tool	Within 2 days after the end of each intervention
Secondary	Fugl-Meyer (FM) Assessment	an upper extremity function evaluation tool	Within 2 days after the end of each intervention
Secondary	Modified Barthel Index	an evaluation tool for assessing activities of daily living	Within 2 days after the end of each intervention
Secondary	Grip strength	Strength of hand grip, palmar pinch and lateral pinch power measured by grip force meter	Within 2 days after the end of each intervention
Secondary	Beck Depression Inventory (BDI)	an evaluation tool for severity of depression in normal and psychiatric populations	Within 2 days after the end of each intervention
Secondary	Simulator Sickness Questionnaire	an evaluation tool for assessing the subjective severity of simulator sickness symptoms	Day 1 and Day 12 of virtual reality exergames intervention