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Идёт набор NCT06229626

Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast

Без фазы С лечением Hereditary Spastic Paraparesis

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: intensive reeducation.
Кому может быть актуально
Состояния в реестре: Hereditary Spastic Paraparesis. 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
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Обзор

Hereditary spastic paraparesis is a group of inherited neurological diseases. Only symptomatic treatments exist for the moment. The Modifspa study (cf citation) carried out by the team showed that patients perceived a feeling of effectiveness of physiotherapy on lower limb spasticity. The aim of the Walk-up study is to objectivize this feeling of efficacy on gait disorders in these patients. This is an interventional study using physical training. The study is prospective, open, randomized in 2 parallel groups, one of which is a control group. Analyses will be comparative between the 2 groups during the course of the study.

Подробное описание

Following an initial study carried out by the team (cf citation), physiotherapy appeared to be the most useful therapy for coping with spasticity, particularly when practised at least 3 times a week. The hypothesis is that this feeling experienced by patients is accurate, and that more frequent physiotherapy (3 additional sessions/week) significantly improves patients' walking speed, with a functional objective.

The main aim of the WALK-UP study is to evaluate the efficacy of a 6-week intensive physical rehabilitation program on walking speed in patients with SPG4 / SPAST-HSP. This is the most frequent genotype in Hereditary Spastic Paraparesis. All patients included in the study will receive at least one physiotherapy session per week in a liberal practice.

Вмешательства

  • Другое intensive reeducation
    * 1 group physiotherapy session per week at the ICM or by videoconference from home for 6 weeks * 2 sessions per week at home with video support sent by e-mail for 6 weeks

Первичные конечные точки

  • to compare the before-and-after variation in distance covered in 6 minutes between the intensive physical rehabilitation group and the control group. [Срок оценки: 6 weeks]
Вторичные конечные точки (12)
  • compare the before-after variation in distance covered in 6 minutes [Срок оценки: 18 weeks]
  • compare the before-after variation in walking speed over a 10-meters test [Срок оценки: 18 weeks]
  • compare the clinical evolution of spasticity [Срок оценки: 18 weeks]
  • compare the lower-limb joint amplitudes [Срок оценки: 18 weeks]
  • compare the patients' mood evolution [Срок оценки: 18 weeks]
  • compare the evolution of cognitive disorders [Срок оценки: 18 weeks]
  • compare the before-after variation in the daily number of steps [Срок оценки: 18 weeks]
  • compare the before-after variation in heart rate [Срок оценки: 18 weeks]
  • compare the frequency and intensity of vesico-sphincter disorders [Срок оценки: 18 weeks]
  • compare the anorectal disorders [Срок оценки: 18 weeks]
  • compare the quality of life [Срок оценки: 18 weeks]
  • compare the fatigue [Срок оценки: 18 weeks]

Критерии участия

Критерии включения

  • Patient with molecular diagnosis of hereditary spastic paraparesis based on pathogenic variant of SPAST gene,
  • Walking possible for 6 minutes without human assistance (one or more technical aids are authorized: e.g. cane, walker, orthoses),
  • At least 1 physiotherapy session per week already in place.
  • Understanding of the protocol
  • Possibility of connecting to the Internet from home to access video material provided as part of the protocol.

Критерии исключения

  • Botulinum toxin injection within 2 months of protocol inclusion
  • Discontinuation of private physiotherapy,
  • Refusal to participate in the protocol,
  • Participation in another interventional clinical trial evaluating a health product or in a randomized clinical trial
  • Pregnant women
  • Not affiliated to a social security scheme or beneficiary of such a scheme
  • Patient under guardianship or trusteeship

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • ICM, Hôpital Pitié-Salpêtrière — Paris

Идентификаторы

NCT: NCT06229626 · APHP230987

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗