Musical Biofeedback for Sensorimotor Control Capacity of Hands

Hand Injuries Clinical Trial

Official title:

Multisensory Biofeedback With Musical Interface for Sensorimotor Control Capacity of Hands

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04802564
• Other study ID #: A-ER-108-557
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: National Cheng-Kung University Hospital
• Contact: Hsiu-Yun Hsu, Ph.D
• Phone: 886-6-2353535
• Email: hyhsu[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand Injuries

Intervention

Other:
• regular hand therapy
edema control, scar management, stretching regimen, tendon gliding exercise, blocking exercise, muscle strengthening protocols

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the result of pinch-holding-up-activity test		8 weeks, 12 weeks and 24 weeks
Secondary	Chang in the result of two-point discrimination (S2PD) test		4 weeks, 8 weeks, 12 weeks and 24 weeks
Secondary	Chang in the result of Semmes-Weinstein monofilament (SWM) test		4 weeks, 8 weeks, 12 weeks and 24 weeks
Secondary	Chang in the result of active range of motion test		4 weeks, 8 weeks, 12 weeks and 24 weeks
Secondary	Change in the result of Purdue pegboard test		8 weeks, 12 weeks and 24 weeks
Secondary	Change in the result of Minnesota manual dexterity test		8 weeks, 12 weeks and 24 weeks
Secondary	Change in the result of Manual ability measurement		4 weeks, 8 weeks, 12 weeks and 24 weeks
Secondary	Change in the result of Near-Infrared Spectroscopy		4 weeks and 12 weeks