Use of Surface Electromyography as a Tools to Predict Upper Extremity Recovery Function After Stroke
NCT ID: NCT06574737
Last Updated: 2024-08-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
30 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-05-01
Study Completion Date
2025-07-31
Brief Summary
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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
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Detailed Description
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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.
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.
Conditions
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Upper Extremity Paresis
Muscle Contracture Upper Arm
Stroke
Study Design
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Observational Model Type
OTHER
Study Time Perspective
OTHER
Eligibility Criteria
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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
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
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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Universitas Padjadjaran
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Berthy Al Mungiza
Bandung, West Java, Indonesia
Site Status
RECRUITING
Countries
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Indonesia
Central Contacts
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Facility Contacts
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References
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Fan J, Li X, Yu X, Liu Z, Jiang Y, Fang Y, Zong M, Suo C, Man Q, Xiong L. Global Burden, Risk Factor Analysis, and Prediction Study of Ischemic Stroke, 1990-2030. Neurology. 2023 Jul 11;101(2):e137-e150. doi: 10.1212/WNL.0000000000207387. Epub 2023 May 17.
Reference Type
RESULT
Venketasubramanian N, Yudiarto FL, Tugasworo D. Stroke Burden and Stroke Services in Indonesia. Cerebrovasc Dis Extra. 2022;12(1):53-57. doi: 10.1159/000524161. Epub 2022 Mar 21.
Reference Type
RESULT
Shelton FN, Reding MJ. Effect of lesion location on upper limb motor recovery after stroke. Stroke. 2001 Jan;32(1):107-12. doi: 10.1161/01.str.32.1.107.
Reference Type
RESULT
Lawrence ES, Coshall C, Dundas R, Stewart J, Rudd AG, Howard R, Wolfe CD. Estimates of the prevalence of acute stroke impairments and disability in a multiethnic population. Stroke. 2001 Jun;32(6):1279-84. doi: 10.1161/01.str.32.6.1279.
Reference Type
RESULT
Feldner HA, Papazian C, Peters KM, Creutzfeldt CJ, Steele KM. Clinical Use of Surface Electromyography to Track Acute Upper Extremity Muscle Recovery after Stroke: A Descriptive Case Study of a Single Patient. Appl Syst Innov. 2021 Jun;4(2):32. doi: 10.3390/asi4020032. Epub 2021 May 10.
Reference Type
RESULT
Steele KM, Papazian C, Feldner HA. Muscle Activity After Stroke: Perspectives on Deploying Surface Electromyography in Acute Care. Front Neurol. 2020 Sep 23;11:576757. doi: 10.3389/fneur.2020.576757. eCollection 2020.
Reference Type
RESULT
Alt Murphy M, Al-Shallawi A, Sunnerhagen KS, Pandyan A. Early prediction of upper limb functioning after stroke using clinical bedside assessments: a prospective longitudinal study. Sci Rep. 2022 Dec 21;12(1):22053. doi: 10.1038/s41598-022-26585-1.
Reference Type
RESULT
Papazian C, Baicoianu NA, Peters KM, Feldner HA, Steele KM. Electromyography Recordings Detect Muscle Activity Before Observable Contractions in Acute Stroke Care. Arch Rehabil Res Clin Transl. 2021 Jun 5;3(3):100136. doi: 10.1016/j.arrct.2021.100136. eCollection 2021 Sep.
Reference Type
RESULT
Stinear CM, Smith MC, Byblow WD. Prediction Tools for Stroke Rehabilitation. Stroke. 2019 Nov;50(11):3314-3322. doi: 10.1161/STROKEAHA.119.025696. Epub 2019 Oct 15. No abstract available.
Reference Type
RESULT
Manzur-Valdivia H, Alvarez-Ruf J. Surface Electromyography in Clinical Practice. A Perspective From a Developing Country. Front Neurol. 2020 Oct 15;11:578829. doi: 10.3389/fneur.2020.578829. eCollection 2020.
Reference Type
RESULT
Ueda S, Aoki H, Yasuda Y, Nishiyama A, Hayashi Y, Honaga K, Tanuma A, Takakura T, Kurosu A, Hatori K, Hayashi A, Fujiwara T. The MMT of Elbow Flexion and the AFE Predict Impairment and Disability at 3 Weeks in Patients With Acute Stroke. Front Neurol. 2022 Mar 30;13:831800. doi: 10.3389/fneur.2022.831800. eCollection 2022.
Reference Type
RESULT
Lv W, Liu K, Zhou P, Huang F, Lu Z. Surface EMG analysis of weakness distribution in upper limb muscles post-stroke. Front Neurol. 2023 Apr 25;14:1135564. doi: 10.3389/fneur.2023.1135564. eCollection 2023.
Reference Type
RESULT
Raghavan P. Upper Limb Motor Impairment After Stroke. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):599-610. doi: 10.1016/j.pmr.2015.06.008. Epub 2015 Aug 25.
Reference Type
RESULT
Li S. Stroke Recovery Is a Journey: Prediction and Potentials of Motor Recovery after a Stroke from a Practical Perspective. Life (Basel). 2023 Oct 15;13(10):2061. doi: 10.3390/life13102061.
Reference Type
RESULT
Grefkes C, Fink GR. Recovery from stroke: current concepts and future perspectives. Neurol Res Pract. 2020 Jun 16;2:17. doi: 10.1186/s42466-020-00060-6. eCollection 2020.
Reference Type
RESULT
Pregnolato G, Rimini D, Baldan F, Maistrello L, Salvalaggio S, Celadon N, Ariano P, Pirri CF, Turolla A. Clinical Features to Predict the Use of a sEMG Wearable Device (REMO(R)) for Hand Motor Training of Stroke Patients: A Cross-Sectional Cohort Study. Int J Environ Res Public Health. 2023 Mar 14;20(6):5082. doi: 10.3390/ijerph20065082.
Reference Type
RESULT
Salvalaggio S, Boccuni L, Turolla A. Patient's assessment and prediction of recovery after stroke: a roadmap for clinicians. Arch Physiother. 2023 Jun 19;13(1):13. doi: 10.1186/s40945-023-00167-4.
Reference Type
RESULT
Roman NA, Miclaus RS, Nicolau C, Sechel G. Customized Manual Muscle Testing for Post-Stroke Upper Extremity Assessment. Brain Sci. 2022 Mar 28;12(4):457. doi: 10.3390/brainsci12040457.
Reference Type
RESULT
Kostka J, Niwald M, Guligowska A, Kostka T, Miller E. Muscle power, contraction velocity and functional performance after stroke. Brain Behav. 2019 Apr;9(4):e01243. doi: 10.1002/brb3.1243. Epub 2019 Feb 28.
Reference Type
RESULT
Pandian S, Arya KN. Stroke-related motor outcome measures: do they quantify the neurophysiological aspects of upper extremity recovery? J Bodyw Mov Ther. 2014 Jul;18(3):412-23. doi: 10.1016/j.jbmt.2013.11.006. Epub 2013 Nov 9.
Reference Type
RESULT
McManus L, De Vito G, Lowery MM. Analysis and Biophysics of Surface EMG for Physiotherapists and Kinesiologists: Toward a Common Language With Rehabilitation Engineers. Front Neurol. 2020 Oct 15;11:576729. doi: 10.3389/fneur.2020.576729. eCollection 2020.
Reference Type
RESULT
Hogrel JY. Clinical applications of surface electromyography in neuromuscular disorders. Neurophysiol Clin. 2005 Jul;35(2-3):59-71. doi: 10.1016/j.neucli.2005.03.001.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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IKFR-202408.01
Identifier Type: -
Identifier Source: org_study_id
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