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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04802564
Other study ID # A-ER-108-557
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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