- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04802564
Musical Biofeedback for Sensorimotor Control Capacity of Hands
August 15, 2025 updated by: National Cheng-Kung University Hospital
Multisensory Biofeedback With Musical Interface for Sensorimotor Control Capacity of Hands
In the proposed study, the investigators assumed that music support treatment, a multisensory-based framework for ameliorating brain plasticity, combined with low-amplitude vibration stimulation can prime motor system and change in motor performance for the patient with a peripheral injury or the loss of a limb.
The specific aim of this study is to develop a Multisensory Biofeedback with Musical Interface system, with the aim of improving the sensorimotor impairment of patients' hands.The expected outcomes of this research are to clarify the effects of application Multisensory Biofeedback with Musical Interface on motor and hand function for patients with hand injuries.
Study Overview
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tainan, Taiwan, 704
- National Cheng-Kung University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- tendon and bone injury in hand, wrist, and forearm; peripheral nerve injury in upper extremity; replantation; a combination of nerve and tendon or vascular injury; the protective sensation of the hand is absent or impaired
Exclusion Criteria:
- patients with deficits in cognition, perception or language comprehension, as well as severe pain and swelling in the upper limbs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multisensory-based music treatment
Using a multisensory-based music treatment synchronizing with vibrotactile stimulation on the finger pulps during the protection phase (week 0-4) for hand injury patients.
|
edema control, scar management, stretching regimen, tendon gliding exercise, blocking exercise, muscle strengthening protocols
|
|
Active Comparator: Traditional sensory reeducation intervention
Using constant and moving tactile stimulation on the finger pulps during the protection phase (week 0-4) for hand injury patients.
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edema control, scar management, stretching regimen, tendon gliding exercise, blocking exercise, muscle strengthening protocols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in the result of pinch-holding-up-activity test
Time Frame: 8 weeks, 12 weeks and 24 weeks
|
8 weeks, 12 weeks and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Chang in the result of two-point discrimination (S2PD) test
Time Frame: 4 weeks, 8 weeks, 12 weeks and 24 weeks
|
4 weeks, 8 weeks, 12 weeks and 24 weeks
|
|
Chang in the result of Semmes-Weinstein monofilament (SWM) test
Time Frame: 4 weeks, 8 weeks, 12 weeks and 24 weeks
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4 weeks, 8 weeks, 12 weeks and 24 weeks
|
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Chang in the result of active range of motion test
Time Frame: 4 weeks, 8 weeks, 12 weeks and 24 weeks
|
4 weeks, 8 weeks, 12 weeks and 24 weeks
|
|
Change in the result of Purdue pegboard test
Time Frame: 8 weeks, 12 weeks and 24 weeks
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8 weeks, 12 weeks and 24 weeks
|
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Change in the result of Minnesota manual dexterity test
Time Frame: 8 weeks, 12 weeks and 24 weeks
|
8 weeks, 12 weeks and 24 weeks
|
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Change in the result of Manual ability measurement
Time Frame: 4 weeks, 8 weeks, 12 weeks and 24 weeks
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4 weeks, 8 weeks, 12 weeks and 24 weeks
|
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Change in the result of Near-Infrared Spectroscopy
Time Frame: 4 weeks and 12 weeks
|
4 weeks and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2021
Primary Completion (Actual)
June 11, 2025
Study Completion (Actual)
June 11, 2025
Study Registration Dates
First Submitted
March 15, 2021
First Submitted That Met QC Criteria
March 15, 2021
First Posted (Actual)
March 17, 2021
Study Record Updates
Last Update Posted (Actual)
August 21, 2025
Last Update Submitted That Met QC Criteria
August 15, 2025
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-ER-108-557
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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