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

NCT06056219 | Completed

• 1 other identifier: B-ER-112-174
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Rehabilitation; Virtual Reality; 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 motor performance score ranges from 0 to 66 for the upper extremity.

  baseline, 9 weeks and 21 weeks

Secondary Outcomes (4)

• Change in the result of Box and block test

  baseline, 9 weeks and 21 weeks

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

  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)

• functional Magnetic Resonance Imaging

  baseline, 9 weeks

Study Arms (2)

Mirror therapy using a mirror box

ACTIVE COMPARATOR

30 minutes' exercise of mirror therapy followed by 20 minutes' task-oriented training

Device: Mirror therapy; Other: Task-oriented training

Virtual reality-based mirror therapy with rhythmic skill training

EXPERIMENTAL

30 minutes' activity of virtual reality-based mirror therapy with rhythmic skill training followed by 20 minutes' task-oriented training

Device: Virtual reality-based mirror therapy with rhythmic skill training; Other: Task-oriented training

Interventions

Mirror therapy DEVICE

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

Mirror therapy using a mirror box

Virtual reality-based mirror therapy with rhythmic skill training DEVICE

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

Virtual reality-based mirror therapy with rhythmic skill training

Task-oriented training OTHER

20 minutes' motor training targeted to goals that are relevant to the functional needs of the patient

Mirror therapy using a mirror box; Virtual reality-based mirror therapy with rhythmic skill training

Eligibility Criteria

• Age: 18 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 and hearing 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, 704, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 28, 2023
• Study Start: October 3, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 24, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)