360 Degrees Virtual Reality-based Mirror Therapy for Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05796843
• Other study ID #: SYU 2023-01-009-001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: May 4, 2023

Study information

• Verified date: May 2023
• Source: Sahmyook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
Korea, Republic of	Myeonji Choonhae Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sahmyook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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