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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04294407
Other study ID # A-ER-107-317
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 6, 2020
Est. completion date July 1, 2025

Study information

Verified date June 2023
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
no intervention in this study

Locations

Country Name City State
Taiwan National Cheng-Kung University Hospital Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surface electromyography device--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) Baseline
Primary Surface electromyography device--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) 3 days after baseline
Primary Surface electromyography device--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) 6 days after baseline
Primary Dynamometer device- muscle strength--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) Baseline
Primary Dynamometer device- range of motion--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) Baseline
Primary Dynamometer device- muscle strength--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) 3 days after baseline
Primary Dynamometer device- range of motion--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) 3 days after baseline
Primary Dynamometer device- muscle strength--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) 6 days after baseline
Primary Dynamometer device- range of motion--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) 6 days after baseline
Primary Modified Ashworth Scale--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) Baseline
Primary Modified Ashworth Scale--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) 3 days after baseline
Primary Modified Ashworth Scale--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) 6 days after baseline
Secondary The Fugl-Meyer Upper Extremity Scale The Fugl-Meyer Upper Extremity Scale is an assessment scale for upper limb function of stroke patients. The scale has 33 movements, which can be rated as 0 to 2 points, of which 0 is impossible and 1 is achievable. 2 points can be completely achieved. FMUE scale has good reliability and validity. Baseline
Secondary Box and Block Test The main purpose of the BBT test is to measure the function of the hand. The test method is to calculate the number of blocks that can be moved from one side of the box across the partition to the other side with one hand in one minute. Baseline
Secondary Action Research Arm Test ARAT is a tool used to evaluate the function of upper limbs of stroke patients. The main test content is to reach out and grasp different objects in a standardized environment, and score the action based on the time to complete the action. There are 19 test items, each of which is scored 4 levels (0 ~ 3). The higher the score, the better the movement performance. Baseline
Secondary Motor Activity Log It is mainly used to evaluate daily life functions, including the frequency of use of motion and the evaluation of motion quality. It is a five-point questionnaire with a total of about 30 questions. The average score of the two items of frequency of use and motion quality will be calculated separately. Baseline
Secondary EQ-5D It is mainly used to assess the quality of life. It is a questionnaire-type scale with a total of six questions. Check the descriptions that match your condition (for example, I cannot perform my daily activities) and score my health status today. 0 to 100 points (100 points: best state; 0 points: worst state of health) Baseline
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