Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

November 20, 2023 updated by: MinYoung Kim, MD, PhD, Bundang CHA Hospital
To investigate the therapeutic effect of including virtual reality-based digital content in the upper limb motor function rehabilitation of stroke patients and to develop a treatment method to improve the upper limb motor function of stroke patients in the future.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

1. Inclusion Criteria for experimental group:

  1. Patients aged 19 to 80 years with unilateral stroke within 6 months of stroke onset
  2. Motor function evaluation: Patients showing moderate or lower upper limb dysfunction with an upper limb FMA (Fugl-Meyer Assessment) score of less than 58 points on the affected side.
  3. Patients receiving or planning to receive exercise rehabilitation treatment 5 days a week

2. Inclusion Criteria for control group:

1) Patients who have been admitted to our hospital's rehabilitation medicine department and received rehabilitation treatment within the past 5 years 2) Patients with unilateral stroke within 6 months of stroke onset who are between 19 and 80 years old at the time of hospitalization 3) Patients who were admitted to the rehabilitation medicine department of our hospital and received exercise rehabilitation treatment for 4 weeks, 5 days a week 4) Patients with similar characteristics below compared to the test group

  • Age: Difference within 5 years
  • Gait function: Functional Ambulatory Category (FAC)
  • Upper extremity function: Fugl-Meyer Assessment (FMA) difference within 6 points
  • Cognitive function: Korean Version of Mini Mental State Examination (K-MMSE) difference within 5 points

  • Daily living skills: Korean Version of Modified Barthel Index (K-MBI) difference within 10 points

    3. Exclusion Criteria:

    1. Accompanying existing serious neurogenic disease
    2. Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc.
    3. Cases where it is difficult to understand task performance due to severe cognitive decline (Korean Mini-Mental State Examination, K-MMSE 10 points or less)
    4. If there are difficulties in conducting research
    5. Other patients who are judged by the principal investigator to have difficulty participating in this study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stroke patients
Behavioral: VR-based occupational therapy
All patients will undergo 20 sessions of virtual reality based occupational therapy for 30 minutes a day, 5 days a week for 4weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment of upper extremity
Time Frame: baseline, 4 weeks after intervention
Fugl-Meyer assessment for motor function of upper extremity in score
baseline, 4 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Korean version of modified Barthel index
Time Frame: baseline, 4 weeks after intervention
Korean version of modified Barthel index for functional status in score
baseline, 4 weeks after intervention
Korean version of mini mental state examination
Time Frame: baseline, 4 weeks after intervention
Korean version of mini mental state examination for cognitive function in score
baseline, 4 weeks after intervention
Grip and pinch strength test
Time Frame: baseline, 4 weeks after intervention
Grip and pinch strength test for hand and finger strength in score
baseline, 4 weeks after intervention
Nine-hole pegboard test
Time Frame: baseline, 4 weeks after intervention
Nine-hole pegboard test for dexterity in seconds
baseline, 4 weeks after intervention
Motion analysis
Time Frame: baseline, 4 weeks after intervention
Motion analysis is a process of measuring and evaluating kinematic and kinetic parameters including moment (Nm/kg) and power(Nm/s*Kg) of each joint through Qualisys motion analysis system
baseline, 4 weeks after intervention

Collaborators and Investigators

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

Sponsor

Bundang CHA 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 (Estimated)

November 27, 2023

Primary Completion (Estimated)

November 27, 2024

Study Completion (Estimated)

November 27, 2024

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-08-032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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