Efficacy of Virtual Reality in Upper Extremity Rehabilita... | NCT06143176

Studies
Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients

NCT06143176

Sponsor

Bundang CHA Hospital

Status

Unknown status

Last Update Posted

Nov 22, 2023Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

VR-based occupational therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2023Estimated

Primary Completion Date

Nov 27, 2024Estimated

Completion Date

Nov 27, 2024Estimated

First Submitted Date

Nov 13, 2023

First Submission Date that Met QC Criteria

Nov 20, 2023

First Posted Date

Nov 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 22, 2023Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Label	Type	Description	Intervention Names
Stroke patients	Experimental		Behavioral: VR-based occupational therapy

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fugl-Meyer Assessment of upper extremity	Fugl-Meyer assessment for motor function of upper extremity in score	baseline, 4 weeks after intervention

Secondary Outcomes

Measure	Description	Time Frame
Korean version of modified Barthel index	Korean version of modified Barthel index for functional status in score	baseline, 4 weeks after intervention
Korean version of mini mental state examination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

1. Inclusion Criteria for experimental group:

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

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases