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Completed

NCT Number: NCT05148052

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Traffic Injury Rehabilitation Hospital, Yangpyeong, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality exergames

Device

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

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Box and Block test

    Time frame: Within 2 days after the end of each intervention

    an upper extremity function evaluation tool

  2. Fugl-Meyer (FM) Assessment

    Time frame: Within 2 days after the end of each intervention

    an upper extremity function evaluation tool

  3. Modified Barthel Index

    Time frame: Within 2 days after the end of each intervention

    an evaluation tool for assessing activities of daily living

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2021
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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