NCT05148052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

November 12, 2021

Last Update Submit

April 22, 2026

Conditions

Stroke

Keywords

StrokeVirtual realityUpper Extremity Paresis

Outcome Measures

Primary Outcomes (1)

  • Action Research Arm Test

    As an upper extremity function evaluation tool, it tests grasp, grip, pinch, and gross arm movement function as sub-tests.

    Within 2 days after the end of each intervention

Secondary Outcomes (6)

  • Box and Block test

    Within 2 days after the end of each intervention

  • Fugl-Meyer (FM) Assessment

    Within 2 days after the end of each intervention

  • Modified Barthel Index

    Within 2 days after the end of each intervention

  • Grip strength

    Within 2 days after the end of each intervention

  • Beck Depression Inventory (BDI)

    Within 2 days after the end of each intervention

  • +1 more secondary outcomes

Study Arms (2)

Conventional therapy first

EXPERIMENTAL

Group receiving conventional occupational therapy first and then virtual reality exergames.

Device: Virtual reality exergamesBehavioral: Conventional occupational therapy

Virtual reality first

EXPERIMENTAL

Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.

Device: Virtual reality exergamesBehavioral: Conventional occupational therapy

Interventions

Virtual reality exergamesDEVICE

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 therapy firstVirtual reality first
Conventional occupational therapyBEHAVIORAL

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.

Conventional therapy firstVirtual reality first

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Traffic Injury Rehabilitation Hospital

Yangp'yŏng, Gyeonggi-do, 12564, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Han Gil Seo, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2021

First Posted

December 8, 2021

Study Start

September 1, 2022

Primary Completion

August 31, 2025

Study Completion

October 31, 2025

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

KR(3)