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临床试验/NCT04294407
NCT04294407招募中不适用

Assessment of Upper Extremity Muscle Spasticity and Impedance Using the Movement and Electromyographical Analyses

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Surface electromyography device--3 days after baseline

研究概览

简要总结

This study intends to use an dynamometer and surface electromyography to objectively and quantitatively measure the corresponding force and electromyography signal generated when the hand joint receives stretching by doing circular motion, and further explore the differences and relationships of existing muscle spasm classification, kinetic and kinematic data, upper extremity performance, activity of daily life. In addition, to investigate the differences of kinetic and kinematic data between stroke patient and healthy participants during doing hand circular motion activity.

详细描述

Purpose 1 : To collect upper limb muscle activity parameters of healthy adults and stroke patients to establish a database of doing hand circular motion activity.

Purpose 2 : To test the reliability of this refined muscle testing by collecting the muscle activity during hand circular motion activity.

Purpose 3 : To compare the results of the EMG signal strength with other evaluation methods such as the modified Ashworth scale and dynamometer to understand the relationship between the EMG signal and each evaluation results.

Purpose 4 : To compare the differences in electromyographic signals, muscle strength, and joint angle between healthy adults and stroke patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 20 to 65 years old
  • with the clinical diagnosis of stroke
  • Mini-mental state examination (MMSE) score ≥ 25 points

排除标准

  • pain, subluxation or related medical history of shoulder, elbow, and wrist joints within six months
  • surgery on shoulder, elbow or wrist
  • with muscle or nerve disorders or diseases that significantly affect the performance of the upper extremities

结局指标

主要结局

Surface electromyography device--3 days after baseline

时间窗: 3 days after baseline

The wireless EMG system will be used to record muscle activity of biceps brachii, triceps brachii, anterior deltoid, and brachioradialis during the hand circular motion activity. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Dynamometer device- muscle strength--Baseline

时间窗: Baseline

A digital dynamometer will be used to measure the maximum elbow flexion/extension force as muscle strength. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Dynamometer device- muscle strength--3 days after baseline

时间窗: 3 days after baseline

A digital dynamometer will be used to measure the maximum elbow flexion/extension force as muscle strength. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Modified Ashworth Scale--6 days after baseline

时间窗: 6 days after baseline

Modified Ashworth Scale (MAS) is a useful assessment tool to classify spasticity.The testing procedure of the MAS is to passively move the joint by the examiner and to feel the resistance during the movements. The scoring of the MAS included 6 level (0, 1, 1+, 2, 3, 4), where no increase muscle tone was score as 0 and rigid joint was score as 4. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Surface electromyography device--Baseline

时间窗: Baseline

The wireless EMG system will be used to record muscle activity of biceps brachii, triceps brachii, anterior deltoid, and brachioradialis during the hand circular motion activity. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Dynamometer device- range of motion--Baseline

时间窗: Baseline

A digital dynamometer will be used to measure the range of motion of elbow flexion/extension. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Dynamometer device- range of motion--6 days after baseline

时间窗: 6 days after baseline

A digital dynamometer will be used to measure the range of motion of elbow flexion/extension. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Modified Ashworth Scale--3 days after baseline

时间窗: 3 days after baseline

Modified Ashworth Scale (MAS) is a useful assessment tool to classify spasticity.The testing procedure of the MAS is to passively move the joint by the examiner and to feel the resistance during the movements. The scoring of the MAS included 6 level (0, 1, 1+, 2, 3, 4), where no increase muscle tone was score as 0 and rigid joint was score as 4. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Surface electromyography device--6 days after baseline

时间窗: 6 days after baseline

The wireless EMG system will be used to record muscle activity of biceps brachii, triceps brachii, anterior deltoid, and brachioradialis during the hand circular motion activity. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Dynamometer device- range of motion--3 days after baseline

时间窗: 3 days after baseline

A digital dynamometer will be used to measure the range of motion of elbow flexion/extension. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Dynamometer device- muscle strength--6 days after baseline

时间窗: 6 days after baseline

A digital dynamometer will be used to measure the maximum elbow flexion/extension force as muscle strength. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

Modified Ashworth Scale--Baseline

时间窗: Baseline

Modified Ashworth Scale (MAS) is a useful assessment tool to classify spasticity.The testing procedure of the MAS is to passively move the joint by the examiner and to feel the resistance during the movements. The scoring of the MAS included 6 level (0, 1, 1+, 2, 3, 4), where no increase muscle tone was score as 0 and rigid joint was score as 4. These data would be collected three times. (Baseline, 3 days after baseline, 6 days after baseline)

次要结局

  • Motor Activity Log(Baseline)
  • The Fugl-Meyer Upper Extremity Scale(Baseline)
  • Box and Block Test(Baseline)
  • Action Research Arm Test(Baseline)
  • EQ-5D(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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