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Идёт набор NCT07419087

Trunk Impairment Scale - Adaptation and Validation in French

Без фазы С лечением Stroke (CVA) or Transient Ischemic Attack Stroke (CVA) or TIA

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 by the TIS.
Кому может быть актуально
Состояния в реестре: Stroke (CVA) or Transient Ischemic Attack, Stroke (CVA) or TIA. Базовые параметры: 18 лет — 85 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 →

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Обзор

The objective of this project is to verify the validity and determine the clinimetric properties after translation and adaptation into French of the Trunk Impairment Scale (TIS), a scale for measuring trunk control and seated balance.

Подробное описание

The research will be conducted in two distinct phases :

* Phase 1: Translation will follow the methodology of translation/back-translation, structural validation of the produced version, and cognitive interview, as recommended by McKown for Performance Outcome Measures. * Phase 2: This involves the metrological study, or validity/reliability study. This phase will be conducted at a single center. It follows a cross-sectional design.

The role of the evaluators (between D2 and D3) will be divided so that the TIS assessments and those related to construct validity are carried out by three different therapists in order to maintain the evaluators' "blindness" regarding the patient's functional level.

Вмешательства

  • Другое Evaluation by the TIS
    The participant will be evaluated using the TIS on two consecutive days. An evaluation will be conducted by two different evaluators.

Первичные конечные точки

  • Content validity [Срок оценки: Through Phase 1 completion (up to 6 months)]
Вторичные конечные точки (10)
  • intra-examiner reliability [Срок оценки: Through Phase 2 completion (up to 21 months)]
  • inter-examiner reliability [Срок оценки: Through Phase 2 completion (up to 21 months)]
  • Internal Consistency [Срок оценки: Through Phase 2 completion (up to 21 months)]
  • Standard Error of Measurement [Срок оценки: Through Phase 2 completion (up to 21 months)]
  • Minimum Detectable Change [Срок оценки: Through Phase 2 completion (up to 21 months)]
  • Convergent validity [Срок оценки: Through Phase 2 completion (up to 21 months)]
  • Known-groups discrimination [Срок оценки: Through Phase 2 completion (up to 21 months)]
  • Concurrent validity [Срок оценки: Through Phase 2 completion (up to 21 months)]
  • Ceiling and Floor Effects [Срок оценки: Through Phase 2 completion (up to 21 months)]
  • Missing data [Срок оценки: Through Phase 2 completion (up to 21 months)]

Критерии участия

Inclusion criteria (Phase 1):

  • Patients over 18 years of age
  • Patients who have had a stroke
  • Full understanding of the French language
  • No cognitive disorders
  • No prior exposure to the TIS scale
  • Covered by a social security system
  • Having been informed, having agreed to participate in the study, and having signed the free and informed consent form.

Inclusion criteria (Phase 2):

  • Patients aged over 18 and under 85 years
  • Having had a stroke, with no time-since-onset limitation
  • Able to sit for 10 seconds without hand support
  • Able to provide informed consent
  • With an NIHSS score between 2 and 26
  • Covered by a social security system
  • Having been informed, having agreed to participate in the study, and having signed the free and informed consent form

Exclusion Criteria (Phase 1):

  • Insufficient command of the French language
  • Inability to understand instructions
  • Persons deprived of liberty (by judicial or administrative decision)
  • Adults under legal protection or unable to express their consent
  • Pregnant or breastfeeding women

Exclusion Criteria (Phase 2):

  • Contraindication to the sitting position or to hip adduction (hip prosthesis)
  • History of orthopedic or neurological disorders affecting sitting balance
  • Insufficient command of the French language
  • Inability to understand instructions
  • Person deprived of liberty (by judicial or administrative decision)
  • Adult under legal protection or unable to express consent
  • Pregnant or breastfeeding woman

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Centre de Kerpape — Ploemeur

Идентификаторы

NCT: NCT07419087 · 2024-A01762-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗