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RecruitingNCT04294407Updated Jun 26, 2023

Using the Movement and Electromyographical Analyses to Assess the Muscle Spasticity

An observational study in Stroke, sponsored by National Cheng-Kung University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-26.

Sponsored by National Cheng-Kung University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2020; still recruiting 6 years 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • spasticity
  • Modified Ashworth Scale (MAS)
  • electromyography
  • kinetics
  • impedance
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Healthy group

    20 to 65 years old healthy subjects, without the clinical diagnosis of stroke

    Other: No intervention

Interventions

  • OtherNo intervention

    no intervention in this study

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline

  2. 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)

    Time frame: 3 days after baseline

  3. 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)

    Time frame: 6 days after baseline

  4. 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)

    Time frame: Baseline

  5. 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)

    Time frame: Baseline

  6. 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)

    Time frame: 3 days after baseline

  7. 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)

    Time frame: 3 days after baseline

  8. 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)

    Time frame: 6 days after baseline

  9. 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)

    Time frame: 6 days after baseline

  10. 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)

    Time frame: Baseline

  11. 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)

    Time frame: 3 days after baseline

  12. 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)

    Time frame: 6 days after baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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)

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • National Cheng-Kung University Hospital
    Tainan, 704, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04294407
Lead sponsor
National Cheng-Kung University Hospital
Responsible party
Sponsor
First posted
Mar 4, 2020
Start date
Jan 6, 2020
Primary completion
Dec 31, 2024 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Jun 26, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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