Clinical trial NCT06143176: Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients
Official title: Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Control group will be recruited by propensity matching with the experimental group according to the dataset from retrospective data
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment of upper extremity
timeFrame: baseline, 4 weeks after intervention
Secondary outcomes:
measure: Korean version of modified Barthel index
timeFrame: baseline, 4 weeks after intervention
measure: Korean version of mini mental state examination
timeFrame: baseline, 4 weeks after intervention
measure: Grip and pinch strength test
timeFrame: baseline, 4 weeks after intervention
measure: Nine-hole pegboard test
timeFrame: baseline, 4 weeks after intervention
measure: Motion analysis
timeFrame: baseline, 4 weeks after intervention
Other outcomes:
Locations:
Study officials:
References: