360 Degrees Virtual Reality-based Mirror Therapy for Stroke Patients
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Apr 2023
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2023
CompletedMay 6, 2023
May 1, 2023
1 month
March 16, 2023
May 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Changes from baseline after 4 weeks of intervention
Secondary Outcomes (2)
Manual Function Test (MFT)
Changes from baseline after 4 weeks of intervention
Box & Block Test (BBT)
Changes from baseline after 4 weeks of intervention
Study Arms (3)
360 Degrees Virtual Reality-based Mirror Therapy Group
EXPERIMENTALThe group which will receive 360 Degrees Virtual Reality-based Mirror Therapy Group
Traditional Mirror Therapy Group
ACTIVE COMPARATORThe group which will receive traditional mirror therapy using a conventional mirror
Conventional Physical Therapy Group
ACTIVE COMPARATORThe group which will receive conventional rehabilitation for upper extremity
Interventions
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.
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Myeonji Choonhae Hospital
Seoul, 07378, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sungbae Jo, PhD candidate
Sahmyook University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physical Therapist
Study Record Dates
First Submitted
March 16, 2023
First Posted
April 4, 2023
Study Start
April 1, 2023
Primary Completion
May 4, 2023
Study Completion
May 4, 2023
Last Updated
May 6, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share