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临床试验/NCT03798340
NCT03798340已完成不适用

Effects of Motor Task-Specific Therapy Synchronized With Vibrotactile Cueing on Sensorimotor Performance of Upper Extremity for the Chronic Stroke Patients

National Cheng-Kung University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年3月24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
20
试验地点
2
主要终点
Change in the result of Fugl-Meyer assessment for UE motor function

研究概览

简要总结

The investigator assumed that perturbed-event-induced vibrotactile cueing enable more precision arm movement adjustment, sensory function and dexterity improvement in the spastic arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can provide vibrotactile feedback through the pinch performance of the hand when countering mechanically induced perturbations and also analyzed training effects of the perturbation-based pinch task training system on the sensorimotor performance of the hands for stroke patients.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of unilateral cerebral infarction or hemorrhage
  • Be able to perform a pinch task with the thumb and index finger
  • With premorbid right-handedness

排除标准

  • Subject has a uncontrolled hypertension
  • Subject has major cognitive-perceptual deficits
  • Subject has other brain disease

研究组 & 干预措施

Vibratory perturbed task-specific movement training

Experimental

Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training

干预措施: Vibratory perturbed task-specific movement training (Other)

Vibratory perturbed task-specific movement training

Experimental

Intervention: 10 minutes of traditional sensorimotor facilitation followed by 20 minutes of vibratory perturbed task-specific movement training

干预措施: Sensorimotor training (Other)

Traditional task-oriented facilitation

Active Comparator

Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training.

干预措施: Traditional task-oriented facilitation (Other)

Traditional task-oriented facilitation

Active Comparator

Intervention:10 minutes of traditional sensorimotor training followed by 20 minutes of reach-to-grasp and hand release training.

干预措施: Sensorimotor training (Other)

结局指标

主要结局

Change in the result of Fugl-Meyer assessment for UE motor function

时间窗: baseline, endpoint (6 weeks) and follow up (18 weeks)

Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.

Change in the result of Semmes-Weinstein monofilament (SWM) test

时间窗: baseline, endpoint (6 weeks) and follow up (18 weeks)

The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.

Change in the result of Modified Ashworth scale (MAS)

时间窗: baseline, endpoint (6 weeks) and follow up (18 weeks)

Muscle tone is defined by the resistance of a muscle being stretched.The tester graded the resistance felt, with a single score. The higher values represent a worse outcome. 0 point for no increase in muscle tone; 1 point for slight increase in muscle tone, manifested by a catch or by minimal resistance at the end of the range of motion (ROM) when the affected part is moved in flexion or extension; 1 + for slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 point for more marked increase in muscle tone through most of the ROM, but affected parteasily moved, 3 point for considerable increase in muscle tone and passive movement difficult; 4 point for affected part rigid in flexion or extension.

Change in the result of Box and blocks test

时间窗: baseline, endpoint (6 weeks) and follow up (18 weeks)

The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.

Change in the result of Motor Activity Log

时间窗: baseline, endpoint (6 weeks) and follow up (18 weeks)

MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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