360 Degrees Virtual Reality-based Mirror Therapy for Stroke Patients

NCT ID: NCT05796843

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-05-04

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.

Conditions

Stroke; Stroke Rehabilitation; Mirror Movement Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

360 Degrees Virtual Reality-based Mirror Therapy Group

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

Group Type: EXPERIMENTAL

360 Degrees virtual reality-based mirror therapy

Intervention Type: PROCEDURE

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.

Conventional Physical Therapy

Intervention Type: PROCEDURE

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

Traditional Mirror Therapy Group

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

Group Type: ACTIVE_COMPARATOR

Traditional mirror therapy

Intervention Type: PROCEDURE

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.

Conventional Physical Therapy

Intervention Type: PROCEDURE

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

Conventional Physical Therapy Group

The group which will receive conventional rehabilitation for upper extremity

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahmyook University

OTHER

Sponsor Role: lead

Responsible Party

Sungbae Jo

Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sungbae Jo, PhD candidate

Role: PRINCIPAL_INVESTIGATOR

Sahmyook University

Locations

Myeonji Choonhae Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SYU 2023-01-009-001

Identifier Type: -

Identifier Source: org_study_id