Rhythmic-Based Training with Immersive Mirror Visual Feedback for Neuro-Rehabilitation

Effects of Rhythmic-Based Training with Immersive Mirror Visual Feedback on Sensorimotor Function of Upper Extremity

In the proposed study, the investigators assumed that rhythmic-based training with immersive mirror visual feedback 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 rhythmic-based training with immersive mirror visual feedback, or mirror therapy on the upper extremity function and brain activity of the stroke patients.

Study Overview

• Status: Completed
• Conditions: Stroke; Rehabilitation; Virtual Reality; Mirror Movement Therapy
• Intervention / Treatment: Device: Mirror therapy; Other: Task-oriented training; Device: Virtual reality-based mirror therapy with rhythmic skill training

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng-Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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 and hearing 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mirror therapy using a mirror box; 30 minutes' exercise of mirror therapy followed by 20 minutes' task-oriented training	Device: Mirror therapy; 30 minutes' mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise of less-affected upper extremity using a mirror box; Other: Task-oriented training; 20 minutes' motor training targeted to goals that are relevant to the functional needs of the patient
Experimental: Virtual reality-based mirror therapy with rhythmic skill training; 30 minutes' activity of virtual reality-based mirror therapy with rhythmic skill training followed by 20 minutes' task-oriented training	Other: Task-oriented training; 20 minutes' motor training targeted to goals that are relevant to the functional needs of the patient; Device: Virtual reality-based mirror therapy with rhythmic skill training; 30 minutes' virtual reality-based mirror therapy with rhythmic skill training included musical exercises involving virtual drums playing with less-affected upper extremity, and synchronized virtual drums playing and singing activity

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 motor performance score ranges from 0 to 66 for the upper extremity.	baseline, 9 weeks and 21 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the result of Box and block test	The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome. The minimum and maximum value is 0 and 150 respectively.	baseline, 9 weeks and 21 weeks
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 (ROM); 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 Semmes-Weinstein monofilament (SWM) test	The Semmes-Weinstein monofilament test 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 activities of daily living. Score range from 0-5. Higher values represent a better outcome	baseline, 9 weeks and 21 weeks

Other Outcome Measures

Outcome Measure	Time Frame
functional Magnetic Resonance Imaging	baseline, 9 weeks

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 24, 2024

Study Registration Dates

• First Submitted: September 17, 2023
• First Submitted That Met QC Criteria: September 24, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: B-ER-112-174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No