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Clinical Trials/NCT05796843
NCT05796843
Completed
Not Applicable

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

Sahmyook University1 site in 1 country45 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Sahmyook University
Enrollment
45
Locations
1
Primary Endpoint
Fugl-Meyer Assessment for upper extremity (FMA-UE)
Status
Completed
Last Updated
2 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
May 4, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sungbae Jo

Physical Therapist

Sahmyook University

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.

Outcomes

Primary Outcomes

Fugl-Meyer Assessment for upper extremity (FMA-UE)

Time Frame: 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 Outcomes

  • Box & Block Test (BBT)(Changes from baseline after 4 weeks of intervention)
  • Manual Function Test (MFT)(Changes from baseline after 4 weeks of intervention)

Study Sites (1)

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