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

October 24, 2022 updated by: Han Gil Seo, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 21417
        • Recruiting
        • Korea Workers' Compensation & Welfare Service Incheon Hospital
        • Contact:
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, Korea, Republic of, 12564
        • Not yet recruiting
        • Korea Worker's Compensation and Welfare Service Incheon Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional therapy first
Group receiving conventional occupational therapy first and then virtual reality exergames.
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.
Experimental: Virtual reality first
Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test
Time Frame: Within 2 days after the end of each intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block test
Time Frame: Within 2 days after the end of each intervention
an upper extremity function evaluation tool
Within 2 days after the end of each intervention
Fugl-Meyer (FM) Assessment
Time Frame: Within 2 days after the end of each intervention
an upper extremity function evaluation tool
Within 2 days after the end of each intervention
Modified Barthel Index
Time Frame: Within 2 days after the end of each intervention
an evaluation tool for assessing activities of daily living
Within 2 days after the end of each intervention
Grip strength
Time Frame: Within 2 days after the end of each intervention
Strength of hand grip, palmar pinch and lateral pinch power measured by grip force meter
Within 2 days after the end of each intervention
Beck Depression Inventory (BDI)
Time Frame: Within 2 days after the end of each intervention
an evaluation tool for severity of depression in normal and psychiatric populations
Within 2 days after the end of each intervention
Simulator Sickness Questionnaire
Time Frame: Day 1 and Day 12 of virtual reality exergames intervention
an evaluation tool for assessing the subjective severity of simulator sickness symptoms
Day 1 and Day 12 of virtual reality exergames intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Asan Medical Center
National Traffic Injury Rehabilitation Hospital
Korea Workers' Compensation and Welfare Service Incheon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stroke-VR-U/Ex

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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