Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

Stroke Clinical Trial

Official title:

Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06143176
• Other study ID #: 2023-08-032
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: November 27, 2024

Study information

• Verified date: November 2023
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: November 27, 2024
• Est. primary completion date: November 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

1. Inclusion Criteria for experimental group:

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

2. 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.

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

2. 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

3. Exclusion Criteria:

1. Accompanying existing serious neurogenic disease

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

3. 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)

4. If there are difficulties in conducting research

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bundang CHA Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment of upper extremity	Fugl-Meyer assessment for motor function of upper extremity in score	baseline, 4 weeks after intervention
Secondary	Korean version of modified Barthel index	Korean version of modified Barthel index for functional status in score	baseline, 4 weeks after intervention
Secondary	Korean version of mini mental state examination	Korean version of mini mental state examination for cognitive function in score	baseline, 4 weeks after intervention
Secondary	Grip and pinch strength test	Grip and pinch strength test for hand and finger strength in score	baseline, 4 weeks after intervention
Secondary	Nine-hole pegboard test	Nine-hole pegboard test for dexterity in seconds	baseline, 4 weeks after intervention
Secondary	Motion analysis	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	baseline, 4 weeks after intervention