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Clinical Trials/NCT05580744
NCT05580744CompletedNot Applicable

Effects of Augmented-reality Based Mirror Therapy on Sensorimotor Function of Upper Extremity

National Cheng-Kung University Hospital1 site in 1 country48 target enrollmentStarted: January 3, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test

Study Overview

Brief Summary

In the proposed study, the investigators assumed that mirror therapy combined with augmented reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either augmented reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Clinical diagnosis of stroke with unilateral side involved;
  • •A score of Mini-mental state examination greater than 24 for proving higher mental function
  • •Time of onset > 6 months before treatment begins; and
  • •Premorbid right-handedness.

Exclusion Criteria

  • •Severe vision impairment;
  • •Major cognitive-perceptual deficit;
  • •Other brain disease.

Arms & Interventions

Traditional occupational therapy

Active Comparator

Traditional occupational therapy delivered skill training related to daily living tasks.

Intervention: Traditional occupational therapy (Other)

Mirror therapy using a mirror box

Active Comparator

Exercise of mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using a mirror box .

Intervention: Mirror therapy using a mirror box (Other)

Augmented reality-based mirror therapy

Experimental

Exercise of augmented reality-based mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using an augmented reality mirror therapy system

.

Intervention: Augmented reality-based mirror therapy (Other)

Outcomes

Primary Outcomes

Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test

Time Frame: baseline, 9 weeks and 21 weeks

Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.

Secondary Outcomes

  • Change in the result of Box and blocks test(baseline, 9 weeks and 21 weeks)
  • Change in the result of Motor Activity Log(baseline, 9 weeks and 21 weeks)
  • Change in the result of Modified Ashworth scale (MAS)(baseline, 9 weeks and 21 weeks)
  • Change in the result of Semmes-Weinstein monofilament (SWM) test(baseline, 9 weeks and 21 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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