Use of Surface Electromyography as a Tools to Predict Upper Extremity Recovery Function After Stroke

Recruiting

• Conditions: Upper Extremity Paresis; Muscle Contracture Upper Arm; Stroke

• Registration Number: NCT06574737
• Lead Sponsor: Universitas Padjadjaran

Brief Summary

Hypothesis :

Based on the framework and premises above, the hypothesis is formulated as follows: H0 : surface electromyography parameters cannot predicts upper extremity motor function recovery in stroke patients H1: surface electromyography parameters can predicts upper extremity motor function recovery in stroke patients

Detailed Description

Study design and setting This study is an analytic quantitative observational study, to analyse the quantification of Manual Muscle Test score, Fugl Mayer Assessment-Upper Extremity score and electrical signals of the anterior deltoid, biceps, triceps, wrist flexors and wrist extensors muscles based on contractions, length of contraction and amplitude parameters in patients with acute phase stroke. This study performed at HasanSadikin Hospital between February 2024 - July 2024. Study participants Potential participants will be recruited by the main researcher

Inclusion criteria:

1. Patients who are hospitalized with upper extremity weakness due to stroke on the same side which confirmed with computed tomography scan or structural magnetic resonance imaging, in the acute phase

2. Men and women aged more than 18 years old

3. Willing to participate

Exclusion criteria:

1. Cognitive impairment (MoCA-Ina score less than 26)

2. Impaired consciousness (GCS score less than 15)

3. Unstable medical conditions at time of hospitalization

4. Patients with pacemaker

5. Having other injury or dysfunction in the impaired side of upper extremity that caused restrictions on the range of joint movement and muscle weakness, such as fractures, periarthritis, or moderate-severe pain

6. Diagnosis of other neurological disease or disorders in addition to stroke (e.g., traumatic brain injury, neuropathy or radiculopathy)

7. Get treated in isolation room

8. Hypersensitivity to gel electrodes

Drop out criteria:

1. Unable to do 2 or more follow up session

2. Withdrawn by themselves

Confounding factor:

1. Stroke location

2. Stroke size

3. Spasticity

4. Rehabilitation program

5. Compliance rehabilitation

6. Stroke risk factor

Sampling Technique The method of sampling based on consecutive samplings, that is, all stroke patients who meet the inclusion and exclusion criteria during the duration of the study.

Based on the formula above, the minimum sample size for this research is adequate, so the minimum sample size is 30 samples.

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-24
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-04-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients who are hospitalized with upper extremity weakness due to stroke on the same side which confirmed with computed tomography (CT) scan or structural magnetic resonance imaging (MRI), in the acute phase
2. Men and women aged more than 18 years old
3. Willing to participate

Exclusion Criteria

1. Cognitive impairment (MoCA-Ina score less than 26)
2. Impaired consciousness (GCS score less than 15)
3. Unstable medical conditions at time of hospitalization
4. Patients with pacemaker
5. Having other injury or dysfunction in the impaired side of upper extremity that caused restrictions on the range of joint movement and muscle weakness, such as fractures, periarthritis, or moderate-severe pain
6. Diagnosis of other neurological disease or disorders in addition to stroke (e.g., traumatic brain injury, neuropathy or radiculopathy)
7. Get treated in isolation room
8. Hypersensitivity to gel electrodes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Electrical activity deltoid, biceps, triceps, wrist flexor, wrist extensor muscle	3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset	* Contraction (number/minute). The number of contractions was reported for each participant as a count of the number of contractions divided per minute time (the more the better outcome) windows analyzed for that participant.; * Length of contraction (millisecond) (the longer the better outcome); * Amplitude (mV) (the more the better outcome)

Secondary Outcome Measures

Name	Time	Method
Fugl Mayer Assessment-Upper Extremity score	3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset	≤25 : severe 26-45 : moderate 46-66 : mild; (66 : maximum score for upper extremity score = normal, the more the better outcome)
Manual Muscle Testing score	3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset	5: Normal 4: Good 3: Fair 2: Poor; 1: Trace 0: Zero; (5 : higher end of strength ability, 0 = low-end ability of strength ability) (the more, the better outcome)

Trial Locations

Locations (1)

Berthy Al Mungiza; 🇮🇩 Bandung, West Java, Indonesia