Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574737
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Use of Surface Electromyography as a Tools to Predict Upper Extremity Recovery Function After Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Surface Electromyography as a Tools to Predict Upper Extremity Recovery Function After Stroke
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None