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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05148052
Enrollment
15
Registered
2021-12-08
Start date
2022-09-01
Completion date
2025-10-31
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Virtual reality, Upper Extremity Paresis

Brief 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.

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. Fifteen 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. \*Due to recruitment challenges, the anticipated enrollment has been revised from 36 to 15.

Interventions

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.

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.

Sponsors

Asan Medical Center
CollaboratorOTHER
National Traffic Injury Rehabilitation Hospital
CollaboratorUNKNOWN
Korea Workers' Compensation and Welfare Service Incheon Hospital
CollaboratorUNKNOWN
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Action Research Arm TestWithin 2 days after the end of each interventionAs an upper extremity function evaluation tool, it tests grasp, grip, pinch, and gross arm movement function as sub-tests.

Secondary

MeasureTime frameDescription
Fugl-Meyer (FM) AssessmentWithin 2 days after the end of each interventionan upper extremity function evaluation tool
Modified Barthel IndexWithin 2 days after the end of each interventionan evaluation tool for assessing activities of daily living
Box and Block testWithin 2 days after the end of each interventionan upper extremity function evaluation tool
Beck Depression Inventory (BDI)Within 2 days after the end of each interventionan evaluation tool for severity of depression in normal and psychiatric populations
Simulator Sickness QuestionnaireDay 1 and Day 12 of virtual reality exergames interventionan evaluation tool for assessing the subjective severity of simulator sickness symptoms
Grip strengthWithin 2 days after the end of each interventionStrength of hand grip, palmar pinch and lateral pinch power measured by grip force meter

Countries

South Korea

Contacts

Primary ContactHan Gil Seo, MD, PhD
hgseo80@gmail.com82-2-2072-1659

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026