Musical Biofeedback for Sensorimotor Control Capacity of Hands

NCT04802564 | Completed

• 1 other identifier: A-ER-108-557
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

musical biofeedback; auditory; vibrotactile stimulation

Outcome Measures

Primary Outcomes (1)

• Change in the result of pinch-holding-up-activity test

  8 weeks, 12 weeks and 24 weeks

Secondary Outcomes (7)

• Chang in the result of two-point discrimination (S2PD) test

  4 weeks, 8 weeks, 12 weeks and 24 weeks

• Chang in the result of Semmes-Weinstein monofilament (SWM) test

  4 weeks, 8 weeks, 12 weeks and 24 weeks

• Chang in the result of active range of motion test

  4 weeks, 8 weeks, 12 weeks and 24 weeks

• Change in the result of Purdue pegboard test

  8 weeks, 12 weeks and 24 weeks

• Change in the result of Minnesota manual dexterity test

  8 weeks, 12 weeks and 24 weeks

Study Arms (2)

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.

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.

Other: regular hand therapy

Interventions

regular hand therapy OTHER

edema control, scar management, stretching regimen, tendon gliding exercise, blocking exercise, muscle strengthening protocols

Multisensory-based music treatment; Traditional sensory reeducation intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients with deficits in cognition, perception or language comprehension, as well as severe pain and swelling in the upper limbs

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, Taiwan, 704, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 34814839 DERIVED

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 17, 2021
• Study Start: March 15, 2021
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: August 21, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)