Recruiting NCT06574737

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

— Observational Upper Extremity Paresis Muscle Contracture Upper Arm Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Upper Extremity Paresis, Muscle Contracture Upper Arm, Stroke. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Indonesia
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

Electrical activity deltoid, biceps, triceps, wrist flexor, wrist extensor muscle [Time frame: 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset]

Secondary outcome measures (2)

Manual Muscle Testing score [Time frame: 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset]
Fugl Mayer Assessment-Upper Extremity score [Time frame: 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset]

Eligibility criteria

Inclusion criteria

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
Men and women aged more than 18 years old
Willing to participate

Exclusion criteria

Cognitive impairment (MoCA-Ina score less than 26)
Impaired consciousness (GCS score less than 15)
Unstable medical conditions at time of hospitalization
Patients with pacemaker
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
Diagnosis of other neurological disease or disorders in addition to stroke (e.g., traumatic brain injury, neuropathy or radiculopathy)
Get treated in isolation room
Hypersensitivity to gel electrodes

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Other

Study locations

Indonesia · 1 center

Berthy Al Mungiza — Bandung

Publications

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. PMID 37197995
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. PMID 35313314
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. PMID 11136923
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. PMID 11387487
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. PMID 34778722
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. PMID 33071953
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. PMID 36543863
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. PMID 34589686

Identifiers

NCT: NCT06574737 · IKFR-202408.01

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗