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Effect of Upper Extremity Rehabilitation Using Immersive Virtual Reality in Chronic Stroke Patients.

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual reality exergames
Conventional occupational therapy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Virtual reality, Upper Extremity Paresis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic stroke patients who have passed 6 months or more without additional stroke after the first stroke
  • Patients with upper extremity dysfunction due to stroke (ischemic, hemorrhagic)
  • Patients who can move the upper extremity against gravity with a manual muscle test of grade 3 or higher in the affected shoulder and elbow, respectively
  • Patients who can stably maintain a sitting position
  • Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

  • Patients with moderate or severe cognitive impairment with a score of 18 or less on the Mini-Mental Status Examination (K-MMSE)
  • Patients with other causes of upper extremity dysfunction, such as peripheral nerve damage, joint disease, etc.
  • Patients with a history of severe vertigo or epilepsy
  • Patients with medical reasons such as medical conditions that make it difficult to participate in research
  • Patients who may be pregnant or who are pregnant or lactating

Sites / Locations

  • Korea Workers' Compensation & Welfare Service Incheon HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical Center
  • Korea Worker's Compensation and Welfare Service Incheon Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional therapy first

Virtual reality first

Arm Description

Group receiving conventional occupational therapy first and then virtual reality exergames.

Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.

Outcomes

Primary Outcome Measures

Action Research Arm Test
As an upper extremity function evaluation tool, it tests grasp, grip, pinch, and gross arm movement function as sub-tests.

Secondary Outcome Measures

Box and Block test
an upper extremity function evaluation tool
Fugl-Meyer (FM) Assessment
an upper extremity function evaluation tool
Modified Barthel Index
an evaluation tool for assessing activities of daily living
Grip strength
Strength of hand grip, palmar pinch and lateral pinch power measured by grip force meter
Beck Depression Inventory (BDI)
an evaluation tool for severity of depression in normal and psychiatric populations
Simulator Sickness Questionnaire
an evaluation tool for assessing the subjective severity of simulator sickness symptoms

Full Information

First Posted
November 12, 2021
Last Updated
October 24, 2022
Sponsor
Seoul National University Hospital
Collaborators
Asan Medical Center, National Traffic Injury Rehabilitation Hospital, Korea Workers' Compensation and Welfare Service Incheon Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05148052
Brief Title
Effect of Upper Extremity Rehabilitation Using Immersive Virtual Reality in Chronic Stroke Patients.
Official Title
Effect of Upper Extremity Rehabilitation Using Fully-immersive Virtual Reality for Motor Recovery in Chronic Stroke Patients: A Prospective, Multicenter, Single-blind, Explorative, Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Asan Medical Center, National Traffic Injury Rehabilitation Hospital, Korea Workers' Compensation and Welfare Service Incheon Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study aimed to investigate the effect of exergames using virtual reality with head mounted device on motor recovery of upper extremities in chronic stroke patients.
Detailed Description
This is a crossover study for comparing conventional occupational therapy and exercise with game format using virtual reality (virtual reality exergame). The virtual reality exergame is designed to maximize the movement of upper extremities, primary to the shoulder and elbow. Thirty-six chronic stroke patient will receive conventional occupational treatment and virtual reality exergame in random order with a two-week-washout period. Outcome measures will be evaluated within two days before and after each treatment, conventional treatment and virtual reality exergame.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Virtual reality, Upper Extremity Paresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional therapy first
Arm Type
Experimental
Arm Description
Group receiving conventional occupational therapy first and then virtual reality exergames.
Arm Title
Virtual reality first
Arm Type
Experimental
Arm Description
Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.
Intervention Type
Device
Intervention Name(s)
Virtual reality exergames
Intervention Description
Twelve sessions of virtual reality exergames involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Conventional occupational therapy
Intervention Description
Conventional occupational therapy involving upper extremities will be conducted. Each session is 30 minutes and will be held 3 times a week. The washout period between the two types of interventions is 2 weeks.
Primary Outcome Measure Information:
Title
Action Research Arm Test
Description
As an upper extremity function evaluation tool, it tests grasp, grip, pinch, and gross arm movement function as sub-tests.
Time Frame
Within 2 days after the end of each intervention
Secondary Outcome Measure Information:
Title
Box and Block test
Description
an upper extremity function evaluation tool
Time Frame
Within 2 days after the end of each intervention
Title
Fugl-Meyer (FM) Assessment
Description
an upper extremity function evaluation tool
Time Frame
Within 2 days after the end of each intervention
Title
Modified Barthel Index
Description
an evaluation tool for assessing activities of daily living
Time Frame
Within 2 days after the end of each intervention
Title
Grip strength
Description
Strength of hand grip, palmar pinch and lateral pinch power measured by grip force meter
Time Frame
Within 2 days after the end of each intervention
Title
Beck Depression Inventory (BDI)
Description
an evaluation tool for severity of depression in normal and psychiatric populations
Time Frame
Within 2 days after the end of each intervention
Title
Simulator Sickness Questionnaire
Description
an evaluation tool for assessing the subjective severity of simulator sickness symptoms
Time Frame
Day 1 and Day 12 of virtual reality exergames intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic stroke patients who have passed 6 months or more without additional stroke after the first stroke Patients with upper extremity dysfunction due to stroke (ischemic, hemorrhagic) Patients who can move the upper extremity against gravity with a manual muscle test of grade 3 or higher in the affected shoulder and elbow, respectively Patients who can stably maintain a sitting position Patients who voluntarily agreed to participate in the study Exclusion Criteria: Patients with moderate or severe cognitive impairment with a score of 18 or less on the Mini-Mental Status Examination (K-MMSE) Patients with other causes of upper extremity dysfunction, such as peripheral nerve damage, joint disease, etc. Patients with a history of severe vertigo or epilepsy Patients with medical reasons such as medical conditions that make it difficult to participate in research Patients who may be pregnant or who are pregnant or lactating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Gil Seo, MD, PhD
Phone
82-2-2072-1659
Email
hgseo80@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Gil Seo, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea Workers' Compensation & Welfare Service Incheon Hospital
City
Incheon
ZIP/Postal Code
21417
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min-Yong Lee, MD
Email
roado10@gmail.com
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Gil Seo, MD, PhD
Phone
82-2-2072-1659
Email
hgseo80@gmail.com
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Hak Lee, MD, PhD
Email
seunghak@gmail.com
Facility Name
Korea Worker's Compensation and Welfare Service Incheon Hospital
City
Seoul
ZIP/Postal Code
12564
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hye Jung Park, MD
Email
petitehj01@naver.com

12. IPD Sharing Statement

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Effect of Upper Extremity Rehabilitation Using Immersive Virtual Reality in Chronic Stroke Patients.

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