Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

NCT ID: NCT06143176

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2024-11-27

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Control group will be recruited by propensity matching with the experimental group according to the dataset from retrospective data
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stroke patients

Group Type EXPERIMENTAL

VR-based occupational therapy

Intervention Type BEHAVIORAL

All patients will undergo 20 sessions of virtual reality based occupational therapy for 30 minutes a day, 5 days a week for 4weeks

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


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

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bundang CHA Hospital

OTHER

Sponsor Role lead

Responsible Party

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MinYoung Kim, MD, PhD

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2023-08-032

Identifier Type: -

Identifier Source: org_study_id