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Набор по приглашению NCT07561359

12-Week Strength and Functional Exercise Program for Hereditary Spastic Paraplegia Trial (HSPMOVE)

Без фазы С лечением Hereditary Spastic Paraplegia

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: Individualized Functional and Strength Exercises.
Кому может быть актуально
Состояния в реестре: Hereditary Spastic Paraplegia. Базовые параметры: 16 лет — 70 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
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

12-Week Strength and Functional Exercise Protocol for Treating Motor Symptoms in Individuals With Hereditary Spastic Paraplegia: Adaptive Randomized Crossover Clinical Trial

Обзор

This study aims to evaluate whether a 12-week program of strength and functional exercises can improve movement and daily function in people with Hereditary Spastic Paraplegia (HSP). Participants will take part in supervised exercise sessions twice a week, delivered by videoconference, with guidance from a physiotherapist. The exercises will be tailored to each participant's abilities and goals and will focus on improving muscle strength, balance, and walking. The study is a randomized crossover trial, meaning that all participants will experience both the exercise program and a comparison period without the intervention. Eligible participants are individuals aged 16 to 70 years with a clinical or genetically confirmed diagnosis of HSP, who are able to walk independently (with or without assistive devices) and have stable treatment for spasticity. Researchers will measure changes in walking ability, balance, muscle strength, and quality of life using clinical scales and functional tests. These include walking tests, mobility assessments, and questionnaires about daily activities and confidence in movement. To reduce bias, outcome assessments will be performed by an evaluator who is blinded to the participants' group allocation. The results of this study will help determine whether a structured exercise program is safe, feasible, and effective for improving motor symptoms in people with HSP, and may support its use as part of routine care.

Вмешательства

  • Другое Individualized Functional and Strength Exercises
    Individualized functional and strength exercise intervention delivered via videoconference and supervised by a physiotherapist. Exercises are tailored according to Goal Attainment Scaling (GAS) and baseline physical activity level. The program consists of two sessions per week and follows key training principles (individuality, overload, adaptation, specificity, continuity, reversibility, and variability) with progressive loading. The intervention focuses on improving lower limb strength and fun

Первичные конечные точки

  • Spastic Paraplegia Rating Scale (SPRS) [Срок оценки: Baseline, 12 and 24 weeks]
  • Timed Up and Go Test (TUG) - maximum walking speed [Срок оценки: Baseline, 12 and 24 weeks]
  • Goal Attainment Scaling (GAS) [Срок оценки: Baseline, 12 and 24 weeks]
Вторичные конечные точки (8)
  • 10-Meter Walk Test (10MWT) - self-selected walking speed [Срок оценки: Baseline, 12 and 24 weeks]
  • 10-Meter Walk Test (10MWT) - maximum walking speed [Срок оценки: Baseline, 12 and 24 weeks]
  • Timed Up and Go (TUG) - self-selected walking speed [Срок оценки: Baseline, 12 and 24 weeks]
  • Falls Efficacy scale - International (Brazilian Portuguese) [Срок оценки: Baseline, 12 and 24 weeks]
  • 36-Item Short Form Health Survey (SF-36) - Brazillian Portuguese [Срок оценки: Baseline, 12 and 24 weeks]
  • Medical Research Council (MRC) Muscle Strength Scale [Срок оценки: Baseline, 12 and 24 weeks]
  • Modified Ashworth Scale (MAS) [Срок оценки: Baseline, 12 and 24 weeks]
  • Patient Global Impression of Change (PGI-C) [Срок оценки: Baseline, 12 and 24 weeks]

Критерии участия

Критерии включения

  • Diagnosis of hereditary spastic paraplegia confirmed by genetic testing or clinical diagnosis with a positive family history
  • Age between 16 and 70 years
  • Independent ambulation, with or without assistive devices
  • Access to an electronic device (smartphone, tablet, or computer) with camera and internet connection
  • Stable therapeutic regimen for spasticity management (pharmacological and/or physiotherapy) for at least 6 months prior to enrollment

Критерии исключения

  • Presence of other neurological or systemic conditions causing additional motor impairment or musculoskeletal injury limiting movement
  • Inability to perform performance outcomes even with assistive devices
  • Planned or ongoing botulinum toxin injections or surgical interventions for spasticity reduction during the 12-week intervention period

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • Centro de Pesquisa Clínica do Hospital de Clinicas de Porto Alegre — Porto Alegre

Публикации

  • Cubillos Arcila DM, Dariva Machado G, Martins VF, Leotti VB, Schule R, Peyre-Tartaruga LA, Saute JAM. Long-term progression of clinician-reported and gait performance outcomes in hereditary spastic paraplegias. Front Neurosci. 2023 Sep 22;17:1226479. doi: 10.3389/fnins.2023.1226479. eCollection 2023. PMID 37811319

Идентификаторы

NCT: NCT07561359 · 2023-0040 · CAAE: 67528023.6.0000.5327

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗