Augmented-reality Based Mirror Therapy in Stroke Rehabilitation

NCT05580744 | Completed

• 1 other identifier: B-ER-111-246
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Rehabilitation; Technology; Mirror Movement Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the result of Modified Ashworth scale (MAS)

  baseline, 9 weeks and 21 weeks

• Change in the result of Box and blocks test

  baseline, 9 weeks and 21 weeks

• Change in the result of Semmes-Weinstein monofilament (SWM) test

  baseline, 9 weeks and 21 weeks

• Change in the result of Motor Activity Log

  baseline, 9 weeks and 21 weeks

Other Outcomes (1)

• changes in oxygenated (HbO) and deoxygenated (Hb) hemoglobin concentrations using near infrared spectroscopy (NIRS)

  baseline, 9 weeks and 21 weeks

Study Arms (3)

Traditional occupational therapy

ACTIVE COMPARATOR

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

Other: Traditional occupational therapy

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 .

Other: Mirror therapy using a mirror box

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 .

Other: Augmented reality-based mirror therapy

Interventions

Traditional occupational therapy OTHER

Motor training targeted to goals that are relevant to the functional needs of the patient

Traditional occupational therapy

Mirror therapy using a mirror box OTHER

Mirror therapy using a mirror box

Mirror therapy using a mirror box

Augmented reality-based mirror therapy OTHER

Augmented reality-based mirror therapy

Augmented reality-based mirror therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Taiwan, 704, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 14, 2022
• Study Start: January 3, 2023
• Primary Completion: May 8, 2024
• Study Completion: May 27, 2024
• Last Updated: December 16, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)