Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

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: Stroke
• Intervention / Treatment: Behavioral: VR-based occupational therapy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	Korean version of modified Barthel index for functional status in score	baseline, 4 weeks after intervention
Korean version of mini mental state examination	Korean version of mini mental state examination for cognitive function in score	baseline, 4 weeks after intervention
Grip and pinch strength test	Grip and pinch strength test for hand and finger strength in score	baseline, 4 weeks after intervention
Nine-hole pegboard test	Nine-hole pegboard test for dexterity in seconds	baseline, 4 weeks after intervention
Motion analysis	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

• Sponsor: Bundang CHA Hospital

Study record dates

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: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• 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