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

Not Applicable
Recruiting
Conditions
Stroke
Interventions
Device: Virtual reality exergames
Behavioral: Conventional occupational therapy
Registration Number
NCT05148052
Lead Sponsor
Seoul National University Hospital
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. Thirty-six 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
36
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Conventional therapy firstConventional occupational therapyGroup receiving conventional occupational therapy first and then virtual reality exergames.
Virtual reality firstVirtual reality exergamesGroup receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.
Virtual reality firstConventional occupational therapyGroup receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.
Conventional therapy firstVirtual reality exergamesGroup receiving conventional occupational therapy first and then virtual reality exergames.
Primary Outcome Measures
NameTimeMethod
Action Research Arm TestWithin 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 Outcome Measures
NameTimeMethod
Box and Block testWithin 2 days after the end of each intervention

an upper extremity function evaluation tool

Fugl-Meyer (FM) AssessmentWithin 2 days after the end of each intervention

an upper extremity function evaluation tool

Modified Barthel IndexWithin 2 days after the end of each intervention

an evaluation tool for assessing activities of daily living

Grip strengthWithin 2 days after the end of each intervention

Strength of hand grip, palmar pinch and lateral pinch power measured by grip force meter

Beck Depression Inventory (BDI)Within 2 days after the end of each intervention

an evaluation tool for severity of depression in normal and psychiatric populations

Simulator Sickness QuestionnaireDay 1 and Day 12 of virtual reality exergames intervention

an evaluation tool for assessing the subjective severity of simulator sickness symptoms

Trial Locations

Locations (4)

Korea Workers' Compensation & Welfare Service Incheon Hospital

🇰🇷

Incheon, Korea, Republic of

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Korea Worker's Compensation and Welfare Service Incheon Hospital

🇰🇷

Seoul, Korea, Republic of

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