Using the Movement and Electromyographical Analyses to Assess the Muscle Spasticity
- Conditions
- Stroke
- Interventions
- Other: No intervention
- Registration Number
- NCT04294407
- Lead Sponsor
- National Cheng-Kung University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 20 to 65 years old
- with the clinical diagnosis of stroke
- Mini-mental state examination (MMSE) score ≥ 25 points
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy group No intervention 20 to 65 years old healthy subjects, without the clinical diagnosis of stroke Stroke group No intervention 20 to 65 years old patients, with the clinical diagnosis of stroke (Mini-mental state examination (MMSE) score of ≥25)
- Primary Outcome Measures
Name Time Method Surface electromyography device--3 days after baseline 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 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 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 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 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 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 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 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 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 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 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 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 Outcome Measures
Name Time Method Motor Activity Log Baseline 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.
The Fugl-Meyer Upper Extremity Scale Baseline 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.
Box and Block Test Baseline 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.
Action Research Arm Test Baseline 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.
EQ-5D Baseline 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)
Trial Locations
- Locations (1)
National Cheng-Kung University Hospital
🇨🇳Tainan, Taiwan