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Идёт набор NCT07357181

Influence of Handedness on Upper Limb Recovery

Наблюдательное 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
В протоколе указаны: evaluation.
Кому может быть актуально
Состояния в реестре: 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Impact of Manual Preference on Motor Deficits After Stroke

Обзор

This prospective, single-center observational study evaluates whether handedness is associated with upper-limb motor recovery after a recent unilateral stroke. Adults admitted to the stroke unit with a confirmed unilateral stroke within 5 days are included if they do not object to participation. Upper-limb impairment is assessed early after stroke and at 6 months using standardized clinical scales. Handedness is determined by self-report, and the Edinburgh Handedness Inventory is administered when feasible. The main hypothesis is that left-handed participants may show better upper-limb motor recovery at 6 months than right-handed participants, potentially due to differences in brain motor network lateralization.

Подробное описание

Participants hospitalized in the stroke unit with a confirmed unilateral stroke are recruited consecutively. After eligibility verification and absence of objection, baseline data are collected within 5 days post-stroke. Baseline assessments include the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), the Shoulder Abduction and Finger Extension (SAFE) score, and the National Institutes of Health Stroke Scale (NIHSS) score (post-acute treatment if thrombolysis or thrombectomy was performed). Handedness is recorded after the motor assessments to maintain assessor blinding regarding group membership; the Edinburgh Handedness Inventory is administered when cognitive status allows. A 6-month follow-up is performed during routine post-stroke consultation at the study site, with repeat FMA-UE and SAFE assessments. The primary analysis compares FMA-UE at 6 months between left-handed and right-handed participants among those with baseline FMA-UE less than 66, using propensity score matching (3:1 right-handed to left-handed) accounting for age, baseline motor deficit, lesion side relative to dominance (dominant vs non-dominant hemisphere), and stroke type (ischemic vs hemorrhagic).

Вмешательства

  • Другое evaluation
    Patients will be evaluated at baseline for Edinburgh Handedness Inventory Laterality Quotient. Patients will be seen again at 6 months as part of their standard post-stroke consultation at Orléans University Hospital by a neurologist from the neurology department. In conjunction with this consultation, an assessment specific to this research study of the FMA-UE and SAFE scores will be carried out by a physiotherapist from the department.

Первичные конечные точки

  • Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score [Срок оценки: month 6]
Вторичные конечные точки (6)
  • Mean Fugl-Meyer Assessment for Upper Extremity (FMA-UE) Score [Срок оценки: Baseline]
  • Proportion of Left-Handed Participants [Срок оценки: Baseline]
  • Mean National Institutes of Health Stroke Scale (NIHSS) Score [Срок оценки: Baseline]
  • Number of Participants With Upper-Limb Weakness [Срок оценки: Baseline]
  • Correlation Between Edinburgh Handedness Inventory Laterality Quotient and Baseline FMA-UE Score [Срок оценки: Baseline]
  • Mean Shoulder Abduction and Finger Extension (SAFE) Score [Срок оценки: Month 6]

Критерии участия

Критерии включения

  • Confirmed unilateral recent stroke (less than 5 days).
  • Age 18 years and older.
  • Participant or proxy does not object to participation

Критерии исключения

  • Prior stroke with residual motor sequelae.
  • Pre-stroke upper-limb deficit.
  • Follow-up at 6 months not planned at Orléans.
  • Protected adult (guardianship/curatorship), person under legal protection, or deprived of liberty.
  • Pregnant or breastfeeding woman.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • CHU Orléans — Orléans

Публикации

  • Harris JE, Eng JJ. Individuals with the dominant hand affected following stroke demonstrate less impairment than those with the nondominant hand affected. Neurorehabil Neural Repair. 2006 Sep;20(3):380-9. doi: 10.1177/1545968305284528. PMID 16885424
  • Papadatou-Pastou M, Ntolka E, Schmitz J, Martin M, Munafo MR, Ocklenburg S, Paracchini S. Human handedness: A meta-analysis. Psychol Bull. 2020 Jun;146(6):481-524. doi: 10.1037/bul0000229. Epub 2020 Apr 2. PMID 32237881
  • Bonnal J, Pila O, Papin C, Lebkowski L, Sarrazin M, Bravo R, Prieur F. Handedness and task demands modulate motor cortex lateralization: A cross-sectional fNIRS study. Neuroimage. 2025 Dec 1;323:121578. doi: 10.1016/j.neuroimage.2025.121578. Epub 2025 Nov 9. PMID 41218702
  • Tzourio-Mazoyer N, Petit L, Zago L, Crivello F, Vinuesa N, Joliot M, Jobard G, Mellet E, Mazoyer B. Between-hand difference in ipsilateral deactivation is associated with hand lateralization: fMRI mapping of 284 volunteers balanced for handedness. Front Hum Neurosci. 2015 Feb 6;9:5. doi: 10.3389/fnhum.2015.00005. eCollection 2015. PMID 25705184
  • Darling WG, Helle N, Pizzimenti MA, Rotella DL, Hynes SM, Ge J, Stilwell-Morecraft KS, Morecraft RJ. Laterality affects spontaneous recovery of contralateral hand motor function following motor cortex injury in rhesus monkeys. Exp Brain Res. 2013 Jul;228(1):9-24. doi: 10.1007/s00221-013-3533-1. Epub 2013 May 8. PMID 23652723
  • Solodkin A, Hlustik P, Noll DC, Small SL. Lateralization of motor circuits and handedness during finger movements. Eur J Neurol. 2001 Sep;8(5):425-34. doi: 10.1046/j.1468-1331.2001.00242.x. PMID 11554905

Идентификаторы

NCT: NCT07357181 · CHUO-2025-19

Первоисточники (государственные реестры)

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