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临床试验/NCT04802564
NCT04802564已完成不适用

Multisensory Biofeedback With Musical Interface for Sensorimotor Control Capacity of Hands

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2021年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
1
主要终点
Change in the result of pinch-holding-up-activity test

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: regular hand therapy (Other)

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.

干预措施: regular hand therapy (Other)

结局指标

主要结局

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

时间窗: 8 weeks, 12 weeks and 24 weeks

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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