360 Degrees Virtual Reality-based Mirror Therapy for Stroke Patients

360 Degrees Virtual Reality-based Mirror Therapy for Upper Extremity Rehabilitation Among Stroke Patients

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Stroke Rehabilitation; Mirror Movement Therapy
• Intervention / Treatment: Procedure: 360 Degrees virtual reality-based mirror therapy; Procedure: Conventional Physical Therapy; Procedure: Traditional mirror therapy

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07378
    • Myeonji Choonhae Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 360 Degrees Virtual Reality-based Mirror Therapy Group; The group which will receive 360 Degrees Virtual Reality-based Mirror Therapy Group	Procedure: 360 Degrees virtual reality-based mirror therapy; 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.; Procedure: Conventional Physical Therapy; 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
Active Comparator: Traditional Mirror Therapy Group; The group which will receive traditional mirror therapy using a conventional mirror	Procedure: Conventional Physical Therapy; 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; Procedure: Traditional mirror therapy; 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.
Active Comparator: Conventional Physical Therapy Group; The group which will receive conventional rehabilitation for upper extremity	Procedure: Conventional Physical Therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Changes from baseline after 4 weeks of intervention
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.	Changes from baseline after 4 weeks of intervention

Collaborators and Investigators

• Sponsor: Sahmyook University
• Investigators: Principal Investigator: Sungbae Jo, PhD candidate, Sahmyook University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): May 4, 2023
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Stroke Rehabilitation; Mirror Movement Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: SYU 2023-01-009-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No