Augmented-reality Based Mirror Therapy in Stroke Rehabilitation

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

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 Overview

• Status: Recruiting
• Conditions: Stroke; Rehabilitation; Technology; Mirror Movement Therapy
• Intervention / Treatment: Other: Traditional occupational therapy; Other: Mirror therapy using a mirror box; Other: Augmented reality-based mirror therapy

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsiu-Yun Hsu, Ph.D; Phone Number: 2669 886-6-2353535; Email: hyhsu@mail.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng-Kung University Hospital
    • Contact: Hsiu-Yun Hsu, Ph.D.; Phone Number: 2669 886-6-2353535; Email: hyhsu@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional occupational therapy; Traditional occupational therapy delivered skill training related to daily living tasks.	Other: Traditional occupational therapy; Motor training targeted to goals that are relevant to the functional needs of the patient
Active Comparator: Mirror therapy using a mirror box; Exercise of mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using a mirror box .	Other: Mirror therapy using a mirror box; Mirror therapy using a mirror box
Experimental: Augmented reality-based mirror therapy; 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 .	Other: Augmented reality-based mirror therapy; Augmented reality-based mirror therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test	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.	baseline, 9 weeks and 21 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the result of Modified Ashworth scale (MAS)	Muscle tone is defined by the resistance of a muscle being stretched without resistance. The MAS scores were distributed across the entire scale, ranging from 0 to 4, that is convenient for the clinician use. The grading of the scale is described as below: 0) no increase in muscle tone; 1) minimal resistance at the end of the range of motion; 1+) slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the reminder (less than half) of the ROM; 2) more marked increase in tone but only after part is easily flexed; 3) considerable increase in tone; and 4) passive movement is difficult and affected part is rigid in flexion or extension.	baseline, 9 weeks and 21 weeks
Change in the result of Box and blocks test	The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.	baseline, 9 weeks and 21 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test	The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.	baseline, 9 weeks and 21 weeks
Change in the result of Motor Activity Log	Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 ADLs. Score range from 0-5. Higher values represent a better outcome.	baseline, 9 weeks and 21 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in oxygenated (HbO) and deoxygenated (Hb) hemoglobin concentrations using near infrared spectroscopy (NIRS)	To investigate the activation of specific brain regions	baseline, 9 weeks and 21 weeks

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: B-ER-111-246

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No