Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

• Sponsor: Bundang CHA Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06143176
• Collaborator: (none)
• Enrollment: 10
• Arm: 1
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: VR-based occupational therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Control group will be recruited by propensity matching with the experimental group according to the dataset from retrospective dataControl group will be recruited by propensity matching with the experimental group according to the dataset from retrospective data
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients
• Anticipated Study Start Date: Nov 27, 2023
• Anticipated Primary Completion Date: Nov 27, 2024
• Anticipated Study Completion Date: Nov 27, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stroke patients	Behavioral: VR-based occupational therapy; All patients will undergo 20 sessions of virtual reality based occupational therapy for 30 minutes a day, 5 days a week for 4weeks

Outcome Measures

Primary Outcome Measures

1. Fugl-Meyer Assessment of upper extremity [baseline, 4 weeks after intervention]

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

Secondary Outcome Measures

1. Korean version of modified Barthel index [baseline, 4 weeks after intervention]

   Korean version of modified Barthel index for functional status in score

2. Korean version of mini mental state examination [baseline, 4 weeks after intervention]

   Korean version of mini mental state examination for cognitive function in score

3. Grip and pinch strength test [baseline, 4 weeks after intervention]

   Grip and pinch strength test for hand and finger strength in score

4. Nine-hole pegboard test [baseline, 4 weeks after intervention]

   Nine-hole pegboard test for dexterity in seconds

5. Motion analysis [baseline, 4 weeks after intervention]

   Motion analysis is a process of measuring and evaluating kinematic and kinetic parameters including moment (Nm/kg) and power(Nm/s*Kg) of each joint through Qualisys motion analysis system

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

1. Inclusion Criteria for experimental group:

2. Patients aged 19 to 80 years with unilateral stroke within 6 months of stroke onset

3. 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.

4. Patients receiving or planning to receive exercise rehabilitation treatment 5 days a week

5. Inclusion Criteria for control group:

1. 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

1. Exclusion Criteria:

2. Accompanying existing serious neurogenic disease

3. Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc.

4. 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)

5. If there are difficulties in conducting research

6. Other patients who are judged by the principal investigator to have difficulty participating in this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bundang CHA Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MinYoung Kim, MD, PhD, Principle investigator, Bundang CHA Hospital
• ClinicalTrials.gov Identifier: NCT06143176
• Other Study ID Numbers: 2023-08-032
• First Posted: Nov 22, 2023
• Last Update Posted: Nov 22, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Nov 22, 2023