Меню
Идёт набор NCT06574737

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

— Наблюдательное Upper Extremity Paresis Muscle Contracture Upper Arm Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Upper Extremity Paresis, Muscle Contracture Upper Arm, Stroke. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индонезия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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

Подробное описание

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.

Первичные конечные точки

  • Electrical activity deltoid, biceps, triceps, wrist flexor, wrist extensor muscle [Срок оценки: 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset]
Вторичные конечные точки (2)
  • Manual Muscle Testing score [Срок оценки: 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 [Срок оценки: 3 days of stroke onset, 5 days of stroke onset, 1 months, 2 months and 3 months after stroke onset]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Индонезия · 1 центр
  • Berthy Al Mungiza — Bandung

Публикации

  • 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

Идентификаторы

NCT: NCT06574737 · IKFR-202408.01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗