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Clinical Trials/NCT04802564
NCT04802564
Completed
Not Applicable

Multisensory Biofeedback With Musical Interface for Sensorimotor Control Capacity of Hands

National Cheng-Kung University Hospital1 site in 1 country73 target enrollmentMarch 15, 2021
ConditionsHand Injuries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hand Injuries
Sponsor
National Cheng-Kung University Hospital
Enrollment
73
Locations
1
Primary Endpoint
Change in the result of pinch-holding-up-activity test
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2021
End Date
June 11, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 8 weeks, 12 weeks and 24 weeks

Secondary Outcomes

  • Chang in the result of Semmes-Weinstein monofilament (SWM) test(4 weeks, 8 weeks, 12 weeks and 24 weeks)
  • Change in the result of Minnesota manual dexterity test(8 weeks, 12 weeks and 24 weeks)
  • Chang in the result of two-point discrimination (S2PD) test(4 weeks, 8 weeks, 12 weeks and 24 weeks)
  • Change in the result of Manual ability measurement(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 Near-Infrared Spectroscopy(4 weeks and 12 weeks)

Study Sites (1)

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