Augmented-reality Based Mirror Therapy in Stroke Rehabilitation

Not Applicable

Completed

• Conditions: Stroke; Mirror Movement Therapy; Rehabilitation; Technology
• Interventions: Other: Mirror therapy using a mirror box; Other: Traditional occupational therapy; Other: Augmented reality-based mirror therapy

• Registration Number: NCT05580744
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-14
• Study Start: 2023-01-03
• Status Verified: 2023-11
• Primary Completion: 2024-05-08
• Study Completion: 2024-05-27
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirror therapy using a mirror box	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 .
Traditional occupational therapy	Traditional occupational therapy	Traditional occupational therapy delivered skill training related to daily living tasks.
Augmented reality-based mirror therapy	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 .

Primary Outcome Measures

Name	Time	Method
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test	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 Outcome Measures

Name	Time	Method
Change in the result of Box and blocks test	baseline, 9 weeks and 21 weeks	The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Change in the result of Motor Activity Log	baseline, 9 weeks and 21 weeks	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.
Change in the result of Modified Ashworth scale (MAS)	baseline, 9 weeks and 21 weeks	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.
Change in the result of Semmes-Weinstein monofilament (SWM) test	baseline, 9 weeks and 21 weeks	The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.

Trial Locations

Locations (1)

National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan