Clinical trial NCT04294407: Using the Movement and Electromyographical Analyses to Assess the Muscle Spasticity
Official title: Assessment of Upper Extremity Muscle Spasticity and Impedance Using the Movement and Electromyographical Analyses
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: spasticity
Modified Ashworth Scale (MAS)
electromyography
kinetics
impedance
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with stroke will be recruited from the Department of Rehabilitation in 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.

Eligibility criteria: 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

Primary outcomes:
measure: Surface electromyography device--Baseline
timeFrame: Baseline
measure: Surface electromyography device--3 days after baseline
timeFrame: 3 days after baseline
measure: Surface electromyography device--6 days after baseline
timeFrame: 6 days after baseline
measure: Dynamometer device- muscle strength--Baseline
timeFrame: Baseline
measure: Dynamometer device- range of motion--Baseline
timeFrame: Baseline
measure: Dynamometer device- muscle strength--3 days after baseline
timeFrame: 3 days after baseline
measure: Dynamometer device- range of motion--3 days after baseline
timeFrame: 3 days after baseline
measure: Dynamometer device- muscle strength--6 days after baseline
timeFrame: 6 days after baseline
measure: Dynamometer device- range of motion--6 days after baseline
timeFrame: 6 days after baseline
measure: Modified Ashworth Scale--Baseline
timeFrame: Baseline
measure: Modified Ashworth Scale--3 days after baseline
timeFrame: 3 days after baseline
measure: Modified Ashworth Scale--6 days after baseline
timeFrame: 6 days after baseline
Secondary outcomes:
measure: The Fugl-Meyer Upper Extremity Scale
timeFrame: Baseline
measure: Box and Block Test
timeFrame: Baseline
measure: Action Research Arm Test
timeFrame: Baseline
measure: Motor Activity Log
timeFrame: Baseline
measure: EQ-5D
timeFrame: Baseline
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References: