Using the Movement and Electromyographical Analyses to Assess the Muscle Spasticity

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng-Kung University Hospital
    • Contact: Li-Chieh Kuo, Ph. D.; Phone Number: 5908 886-62353535; Email: jkkuo@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants with stroke will be recruited from the Department of Rehabilitation in National Cheng Kung University Hospital.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stroke group; 20 to 65 years old patients, with the clinical diagnosis of stroke (Mini-mental state examination (MMSE) score of ≥25)	Other: No intervention; no intervention in this study
Healthy group; 20 to 65 years old healthy subjects, without the clinical diagnosis of stroke	Other: No intervention; no intervention in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: March 1, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: spasticity; electromyography; impedance; kinetics; Modified Ashworth Scale (MAS)
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: A-ER-107-317

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No