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360 Degrees Virtual Reality-based Mirror Therapy for Stroke Patients

Primary Purpose

Stroke, Stroke Rehabilitation, Mirror Movement Therapy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
360 Degrees virtual reality-based mirror therapy
Traditional mirror therapy
Conventional Physical Therapy
Sponsored by
Sahmyook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Stroke Rehabilitation, Mirror Movement Therapy

Eligibility Criteria

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

Inclusion Criteria: who have not passed 12 months since onset; who can understand and follow instructions; who have ≥21 scores in Korean version of Mini-Mental State Examination (MMSE-K); who have mild to moderate motor impairment according to the Fugl Meyer Assessment (FMA) scores Exclusion Criteria: patients who have any kinds of mental disorder and/or Alzheimer's disease; who have orthopedic and/or musculoskeletal injury; who have apraxia; and who have previous experiences of participating in investigations and/or mirror therapy.

Sites / Locations

  • Myeonji Choonhae Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

360 Degrees Virtual Reality-based Mirror Therapy Group

Traditional Mirror Therapy Group

Conventional Physical Therapy Group

Arm Description

The group which will receive 360 Degrees Virtual Reality-based Mirror Therapy Group

The group which will receive traditional mirror therapy using a conventional mirror

The group which will receive conventional rehabilitation for upper extremity

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment for upper extremity (FMA-UE)
The test is one of the most frequently used evaluation tools that quantitatively assesses recovery after stroke by measuring motor skills, balance ability, sensory function, and range of motion. The maximum total score for FMA-UE is 66 points, containing 18 items to evaluate shoulder, elbow, and forearm; 5 for the wrist; 7 for the hand; and 3 items for coordination.

Secondary Outcome Measures

Manual Function Test (MFT)
This test can reflect the degree of upper extremity dysfunction after stroke, consists of four items each for shoulder and hands. The MFT has a maximum total score of 32 points
Box & Block Test (BBT)
used to evaluate manual dexterity of the hands. The evaluation involves wooden blocks (2.5 cm3) placed in a box (53.7cm x 8.5 cm x 27.4cm) which is divided by a partition in the center. The subjects were instructed to move as many boxes as possible from one side to another in one minute using their affected upper limbs.

Full Information

First Posted
March 16, 2023
Last Updated
May 4, 2023
Sponsor
Sahmyook University
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1. Study Identification

Unique Protocol Identification Number
NCT05796843
Brief Title
360 Degrees Virtual Reality-based Mirror Therapy for Stroke Patients
Official Title
360 Degrees Virtual Reality-based Mirror Therapy for Upper Extremity Rehabilitation Among Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
May 4, 2023 (Actual)
Study Completion Date
May 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahmyook University

4. Oversight

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

5. Study Description

Brief Summary
The goal of this randomized controlled trial is to compare the effects of 360 degree virtual reality-based mirror therapy (360MT) to traditional mirror therapy (TMT) and conventional physical therapy (control group) on upper extremity function among stroke patients. The main questions it aims to answer are: Would 360MT be more effective when treated for 4 weeks in outcome measure ments including: Fugl-Meyer Assessment for upper extremity (FMA-UE); manual function test (MFT); and box & block test (BBT)? How would particants' experience be in terms of satisfactory and enjoyment during 360MT? The study will have three groups of participants who will be involved in different tasks: 360MT group: will receive mirror therapy using a virtual reality device (HMD) and perform tasks with their paralyzed hand. Sessions will last 30 minutes, 3 times a week for 4 weeks. TMT group: will receive mirror therapy using an acrylic mirror and perform finger, wrist, elbow exercises using their paralyzed limb. Sessions will last 30 minutes, 3 times a week for 4 weeks. Control group: will receive conventional physical therapy consisting of exercises for the upper extremity, 60 minutes per day, 5 sessions a week, for 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke Rehabilitation, Mirror Movement Therapy
Keywords
Stroke, Stroke Rehabilitation, Mirror Movement Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
360 Degrees Virtual Reality-based Mirror Therapy Group
Arm Type
Experimental
Arm Description
The group which will receive 360 Degrees Virtual Reality-based Mirror Therapy Group
Arm Title
Traditional Mirror Therapy Group
Arm Type
Active Comparator
Arm Description
The group which will receive traditional mirror therapy using a conventional mirror
Arm Title
Conventional Physical Therapy Group
Arm Type
Active Comparator
Arm Description
The group which will receive conventional rehabilitation for upper extremity
Intervention Type
Procedure
Intervention Name(s)
360 Degrees virtual reality-based mirror therapy
Intervention Description
Participants will receive mirror therapy using a virtual reality device (Pico G2 VR 4K, Pico, China). They will be asked to follow tasks that are played in HMD using their paralyzed hand. The video played using HMD will be video taped using 360 degree camera prior to the treatment. The 360MT will last 30 minutes/session, 3 sessions a week for 4 weeks. The tasks are finger flexion-extension, wrist flexion-extension and pronation-supination, and elbow flexion-extension for ten repetitions.
Intervention Type
Procedure
Intervention Name(s)
Traditional mirror therapy
Intervention Description
Participants will receive mirror therapy using an acrylic mirror (40cm x 40cm x 3cm) that reflects unparalyzed side of them. They will be asked to perform tasks including finger flexion-extension, wrist flexion-extension and pronation-supination, and elbow flexion-extension for ten repetitions. They will be asked to follow the reflection on mirror using their paralyzed limb. The TMT will last 30 minutes/session, 3 sessions a week for 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
Participants will receive conventional physical therapy including neurodevelopmental therapy, muscle strengthening exercises, and joint mobilization which will be provided 60 minutes per day, 5 sessions a week, for 4 weeks. The therapy will follow upper extremity rehabilitation protocol which consists of three phases of warm up, circuit, and cool down exercises
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment for upper extremity (FMA-UE)
Description
The test is one of the most frequently used evaluation tools that quantitatively assesses recovery after stroke by measuring motor skills, balance ability, sensory function, and range of motion. The maximum total score for FMA-UE is 66 points, containing 18 items to evaluate shoulder, elbow, and forearm; 5 for the wrist; 7 for the hand; and 3 items for coordination.
Time Frame
Changes from baseline after 4 weeks of intervention
Secondary Outcome Measure Information:
Title
Manual Function Test (MFT)
Description
This test can reflect the degree of upper extremity dysfunction after stroke, consists of four items each for shoulder and hands. The MFT has a maximum total score of 32 points
Time Frame
Changes from baseline after 4 weeks of intervention
Title
Box & Block Test (BBT)
Description
used to evaluate manual dexterity of the hands. The evaluation involves wooden blocks (2.5 cm3) placed in a box (53.7cm x 8.5 cm x 27.4cm) which is divided by a partition in the center. The subjects were instructed to move as many boxes as possible from one side to another in one minute using their affected upper limbs.
Time Frame
Changes from baseline after 4 weeks of intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: who have not passed 12 months since onset; who can understand and follow instructions; who have ≥21 scores in Korean version of Mini-Mental State Examination (MMSE-K); who have mild to moderate motor impairment according to the Fugl Meyer Assessment (FMA) scores Exclusion Criteria: patients who have any kinds of mental disorder and/or Alzheimer's disease; who have orthopedic and/or musculoskeletal injury; who have apraxia; and who have previous experiences of participating in investigations and/or mirror therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sungbae Jo, PhD candidate
Organizational Affiliation
Sahmyook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Myeonji Choonhae Hospital
City
Seoul
ZIP/Postal Code
07378
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

360 Degrees Virtual Reality-based Mirror Therapy for Stroke Patients

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