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Clinical Trials/NCT04294407
NCT04294407
Recruiting
N/A

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

National Cheng-Kung University Hospital1 site in 1 country100 target enrollmentJanuary 6, 2020
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
National Cheng-Kung University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Surface electromyography device--3 days after baseline
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 6, 2020
End Date
July 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Surface electromyography device--3 days after baseline

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Secondary Outcomes

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

Study Sites (1)

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