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Musical Biofeedback for Sensorimotor Control Capacity of Hands

Primary Purpose

Hand Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
regular hand therapy
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Injuries focused on measuring musical biofeedback, auditory, vibrotactile stimulation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cheng-Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multisensory-based music treatment

Traditional sensory reeducation intervention

Arm Description

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.

Using constant and moving tactile stimulation on the finger pulps during the protection phase (week 0-4) for hand injury patients.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Chang in the result of two-point discrimination (S2PD) test
Chang in the result of Semmes-Weinstein monofilament (SWM) test
Chang in the result of active range of motion test
Change in the result of Purdue pegboard test
Change in the result of Minnesota manual dexterity test
Change in the result of Manual ability measurement
Change in the result of Near-Infrared Spectroscopy

Full Information

First Posted
March 15, 2021
Last Updated
September 29, 2022
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04802564
Brief Title
Musical Biofeedback for Sensorimotor Control Capacity of Hands
Official Title
Multisensory Biofeedback With Musical Interface for Sensorimotor Control Capacity of Hands
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries
Keywords
musical biofeedback, auditory, vibrotactile stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multisensory-based music treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional sensory reeducation intervention
Arm Type
Active Comparator
Arm Description
Using constant and moving tactile stimulation on the finger pulps during the protection phase (week 0-4) for hand injury patients.
Intervention Type
Other
Intervention Name(s)
regular hand therapy
Intervention Description
edema control, scar management, stretching regimen, tendon gliding exercise, blocking exercise, muscle strengthening protocols
Primary Outcome Measure Information:
Title
Change in the result of pinch-holding-up-activity test
Time Frame
8 weeks, 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Chang in the result of two-point discrimination (S2PD) test
Time Frame
4 weeks, 8 weeks, 12 weeks and 24 weeks
Title
Chang in the result of Semmes-Weinstein monofilament (SWM) test
Time Frame
4 weeks, 8 weeks, 12 weeks and 24 weeks
Title
Chang in the result of active range of motion test
Time Frame
4 weeks, 8 weeks, 12 weeks and 24 weeks
Title
Change in the result of Purdue pegboard test
Time Frame
8 weeks, 12 weeks and 24 weeks
Title
Change in the result of Minnesota manual dexterity test
Time Frame
8 weeks, 12 weeks and 24 weeks
Title
Change in the result of Manual ability measurement
Time Frame
4 weeks, 8 weeks, 12 weeks and 24 weeks
Title
Change in the result of Near-Infrared Spectroscopy
Time Frame
4 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiu-Yun Hsu, Ph.D
Phone
886-6-2353535
Ext
2669
Email
hyhsu@mail.ncku.edu.tw
Facility Information:
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiu-Yun Hsu, Ph.D.
Phone
886-6-2353535
Ext
2669
Email
hyhsu@mail.ncku.edu.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
34814839
Citation
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.
Results Reference
derived

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Musical Biofeedback for Sensorimotor Control Capacity of Hands

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