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

Status

Completed

Conditions

Intervention / Treatment

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

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

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.
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
4 weeks, 8 weeks, 12 weeks and 24 weeks
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
8 weeks, 12 weeks and 24 weeks
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
Change in the result of Manual ability measurement
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 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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