360 Degrees Virtual Reality-based Mirror Therapy for Stroke Patients

Sponsor
Sahmyook University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05796843
Collaborator
(none)
45
1
3
5
9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 360 Degrees virtual reality-based mirror therapy
  • Procedure: Traditional mirror therapy
  • Procedure: Conventional Physical Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
360 Degrees Virtual Reality-based Mirror Therapy for Upper Extremity Rehabilitation Among Stroke Patients
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

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: 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.

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: 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

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment for upper extremity (FMA-UE) [Changes from baseline after 4 weeks of intervention]

    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

  1. Manual Function Test (MFT) [Changes from baseline after 4 weeks of intervention]

    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

  2. Box & Block Test (BBT) [Changes from baseline after 4 weeks of intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Myeonji Choonhae Hospital Seoul Korea, Republic of 07378

Sponsors and Collaborators

  • Sahmyook University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sungbae Jo, Physical Therapist, Sahmyook University
ClinicalTrials.gov Identifier:
NCT05796843
Other Study ID Numbers:
  • SYU 2023-01-009-001
First Posted:
Apr 4, 2023
Last Update Posted:
Apr 4, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sungbae Jo, Physical Therapist, Sahmyook University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2023