Using the Movement and Electromyographical Analyses to Assess the Muscle Spasticity

NCT04294407 | Unknown

• 1 other identifier: A-ER-107-317
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

spasticity; Modified Ashworth Scale (MAS); electromyography; kinetics; impedance

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (5)

• The Fugl-Meyer Upper Extremity Scale

  Baseline

• Box and Block Test

  Baseline

• Action Research Arm Test

  Baseline

• Motor Activity Log

  Baseline

• EQ-5D

  Baseline

Study Arms (2)

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

No intervention OTHER

no intervention in this study

Healthy group; Stroke group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: March 4, 2020
• Study Start: January 6, 2020
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

TW (1)