Hand InjuriesNCT04802564
Musical Biofeedback for Sensorimotor Control Capacity of Hands
A study testing regular hand therapy in people with Hand Injuries, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hand Injuries
- What is being tested?
- regular hand therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2021to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with deficits in cognition, perception or language comprehension, as well as severe pain and swelling in the upper limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hand Injuries
- Being tested
- regular hand therapy
- Keywords
- musical biofeedback, auditory, vibrotactile stimulation
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular hand therapyOther
edema control, scar management, stretching regimen, tendon gliding exercise, blocking exercise, muscle strengthening protocols
| Study group | Role | What they receive |
|---|---|---|
| Multisensory-based music treatment | Experimental | 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. Receives: Other: regular hand therapy |
| Traditional sensory reeducation intervention | Active comparator | Using constant and moving tactile stimulation on the finger pulps during the protection phase (week 0-4) for hand injury patients. Receives: Other: regular hand therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the result of pinch-holding-up-activity test
Measured: 8 weeks, 12 weeks and 24 weeks
Secondary outcomes (7)
Chang in the result of two-point discrimination (S2PD) test
Measured: 4 weeks, 8 weeks, 12 weeks and 24 weeks
Chang in the result of Semmes-Weinstein monofilament (SWM) test
Measured: 4 weeks, 8 weeks, 12 weeks and 24 weeks
Chang in the result of active range of motion test
Measured: 4 weeks, 8 weeks, 12 weeks and 24 weeks
Change in the result of Purdue pegboard test
Measured: 8 weeks, 12 weeks and 24 weeks
Change in the result of Minnesota manual dexterity test
Measured: 8 weeks, 12 weeks and 24 weeks
Change in the result of Manual ability measurement
Measured: 4 weeks, 8 weeks, 12 weeks and 24 weeks
Change in the result of Near-Infrared Spectroscopy
Measured: 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start15 Mar 2021
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802564
- Sponsor's protocol ID
- A-ER-108-557
- Status last verified
- Nov 2024
- First submitted
- 15 Mar 2021
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsu HY, Lin CW, Lin YC, Wu PT, Kato H, Su FC, Kuo LC. Effects of vibrotactile-enhanced music-based intervention on sensorimotor control capacity in the hand of an aging brain: a pilot feasibility randomized crossover trial. BMC Geriatr. 2021 Nov 23;21(1):660. doi: 10.1186/s12877-021-02604-0.
PubMed 34814839
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisensory Biofeedback With Musical Interface for Sensorimotor Control Capacity of Hands
- ClinicalTrials.gov ID
- NCT04802564
- Acronym / sponsor ID
- A-ER-108-557
- Conditions
- Hand Injuries
- Keywords
- musical biofeedback, auditory, vibrotactile stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisensory-based music treatment | Experimental | Other: regular hand therapyUsing a multisensory-based music treatment synchronizing with vibrotactile stimulation on the finger pulps during the protection phase (week 0-4) for hand injury patients. |
| Traditional sensory reeducation intervention | Active comparator | Other: regular hand therapyUsing constant and moving tactile stimulation on the finger pulps during the protection phase (week 0-4) for hand injury patients. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- patients with deficits in cognition, perception or language comprehension, as well as severe pain and swelling in the upper limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regular hand therapyedema control, scar management, stretching regimen, tendon gliding exercise, blocking exercise, muscle strengthening protocols | Other | Multisensory-based music treatment, Traditional sensory reeducation intervention |
Primary outcome
Change in the result of pinch-holding-up-activity test
Time frame: 8 weeks, 12 weeks and 24 weeks
7 secondary outcomes
Chang in the result of two-point discrimination (S2PD) test
Time frame: 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
Chang in the result of active range of motion test
Time frame: 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
Change in the result of Minnesota manual dexterity test
Time frame: 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
Change in the result of Near-Infrared Spectroscopy
Time frame: 4 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 34814839Hsu HY, Lin CW, Lin YC, Wu PT, Kato H, Su FC, Kuo LC. Effects of vibrotactile-enhanced music-based intervention on sensorimotor control capacity in the hand of an aging brain: a pilot feasibility randomized crossover trial. BMC Geriatr. 2021 Nov 23;21(1):660. doi: 10.1186/s12877-021-02604-0.
- Individual participant dataSharing planned: No
Related trials for Hand Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Recruiting
Conservative Treatment With Relative Motion Flexion Orthosis for Boutonniere Injuries in Fingers
Finger Joint Deformities, Tendon Injuries
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regular hand therapy in people with Hand Injuries, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the result of pinch-holding-up-activity test (time frame: 8 weeks, 12 weeks and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04802564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.