Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

NCT06143176 | Unknown

• 1 other identifier: 2023-08-032
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment of upper extremity

  Fugl-Meyer assessment for motor function of upper extremity in score

  baseline, 4 weeks after intervention

Secondary Outcomes (5)

• Korean version of modified Barthel index

  baseline, 4 weeks after intervention

• Korean version of mini mental state examination

  baseline, 4 weeks after intervention

• Grip and pinch strength test

  baseline, 4 weeks after intervention

• Nine-hole pegboard test

  baseline, 4 weeks after intervention

• Motion analysis

  baseline, 4 weeks after intervention

Study Arms (1)

Stroke patients

EXPERIMENTAL

Behavioral: VR-based occupational therapy

Interventions

VR-based occupational therapy BEHAVIORAL

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

Stroke patients

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 19 to 80 years with unilateral stroke within 6 months of stroke onset
• 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.
• Patients receiving or planning to receive exercise rehabilitation treatment 5 days a week
• \) 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

You may not qualify if:

• Accompanying existing serious neurogenic disease
• Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc.
• 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)
• If there are difficulties in conducting research
• Other patients who are judged by the principal investigator to have difficulty participating in this study.

Sponsors & Collaborators

• Bundang CHA Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Control group will be recruited by propensity matching with the experimental group according to the dataset from retrospective data

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 22, 2023
• Study Start: November 27, 2023
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share