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

Not Applicable

Completed

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

• Registration Number: NCT06056219
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-17
• Study First Submitted QC: 2023-09-24
• Study First Posted: 2023-09-28
• Study Start: 2023-10-03
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirror therapy using a mirror box	Mirror therapy	30 minutes' exercise of mirror therapy followed by 20 minutes' task-oriented training
Virtual reality-based mirror therapy with rhythmic skill training	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
Virtual reality-based mirror therapy with rhythmic skill training	Task-oriented training	30 minutes' activity of virtual reality-based mirror therapy with rhythmic skill training followed by 20 minutes' task-oriented training
Mirror therapy using a mirror box	Task-oriented training	30 minutes' exercise of mirror therapy followed by 20 minutes' task-oriented training

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 motor performance score ranges from 0 to 66 for the upper extremity.

Secondary Outcome Measures

Name	Time	Method
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 activities of daily living. Score range from 0-5. Higher values represent a better outcome
Change in the result of Box and block 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. The minimum and maximum value is 0 and 150 respectively.
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 (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.
Change in the result of Semmes-Weinstein monofilament (SWM) test	baseline, 9 weeks and 21 weeks	The Semmes-Weinstein monofilament test 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