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Набор скоро начнётся NCT06643923

Effects of Lumbopelvic Stabilization-based Physiotherapy and Rehabilitation Training in Duchenne Muscular Dystrophy

Без фазы С лечением Duchenne Muscular Dystrophy (DMD) Lower Urinary Track Symptoms

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: Exercise, Urotherapy.
Кому может быть актуально
Состояния в реестре: Duchenne Muscular Dystrophy (DMD), Lower Urinary Track Symptoms. Базовые параметры: 8 лет — 12 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Investigation of the Effects of Lumbopelvic Stabilization-based Physiotherapy and Rehabilitation Training on Lower Urinary Tract Symptoms in Children With Duchenne Muscular Dystrophy and Lower Urinary Tract Dysfunction

Обзор

This study aims to examine the effectiveness of supervised lumbopelvic stabilization in relation to factors associated with lower urinary tract symptoms in children diagnosed with Duchenne Muscular Dystrophy (DMD) who have lower urinary tract dysfunction. Children aged between 8 and 12 years, at stages 1-4 according to the Vignos scale, and who have a score of 8.5 or higher on the Dysfunctional Voiding Symptom Score (DVSS), will be included in the study. Demographic information will be collected through a general assessment form, while lower urinary tract symptoms will be assessed using the DVSS, a researcher-developed evaluation form, and a three-day bladder diary. Bowel symptoms will be evaluated using the Rome IV criteria and a seven-day bowel diary. Physical performance will be assessed via the Timed Up and Go Test and Gower's Test, muscle strength using the microFET2 hand dynamometer, lumbar lordosis angle with a Bubble inclinometer, participation in daily living activities via the Barthel Index, and perceived well-being of both the child and the parent will be assessed using the Faces Rating Scale. Participants will be randomly assigned to two groups (Treatment and Active Control) using a block randomization method. In the Active Control group, children will receive only urotherapy education. In the Treatment group, children will receive supervised, online, lumbopelvic exercise-based physiotherapy and rehabilitation sessions, in addition to urotherapy, conducted by a physiotherapist. The sessions will last eight weeks, with a total of 24 sessions. At the end of the eight-week period, both groups will be re-evaluated using the same assessment methods. Intra-group and inter-group comparisons will be completed using appropriate analytical methods.

Вмешательства

  • Другое Exercise
    F (Frequency): 3 days per week, with a total of 24 sessions. I (Intensity): Low to moderate intensity exercises with progression, ensuring no fatigue is induced. T (Time): Each session will last 30 minutes, over a total period of 8 weeks. T (Type): Warm-up exercises Core stabilization exercises: Aimed at improving core stability. Cool-down exercises E (Enjoyment): Gamified exercises, with sessions conducted to music. A (Adherence): A follow-up system will be implemented, including reminder no
  • Поведенческое Urotherapy
    The urotherapy education program was developed by an expert physiotherapist and was piloted with the families of children with DMD (16 parents) prior to the study. Pre-test and post-test assessments demonstrated that the knowledge level of DMD families increased after the training. Additionally, results from the satisfaction survey indicated a high level of satisfaction among the families regarding the urotherapy education (Mean satisfaction score: 33.875/35.000, Minimum=28, Maximum=35). Therefo

Первичные конечные точки

  • Lower urinary tract symptoms assessment [Срок оценки: 8 weeks]
Вторичные конечные точки (7)
  • Bowel symptom assessment [Срок оценки: 8 weeks]
  • Physical performance assessment [Срок оценки: 8 weeks]
  • Muscle strength assessment [Срок оценки: 8 weeks]
  • Lumbar lordosis angle assessment [Срок оценки: 8 weeks]
  • Evaluation of participation in daily living activities [Срок оценки: 8 weeks]
  • Perceived well-being assessment [Срок оценки: 8 weeks]
  • Physical performance assessment [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • Having been diagnosed with DMD by a specialist physician,
  • Having received a score of 8.5 or higher on the Voiding Disorders Symptom Score (VMSS),
  • Being between the ages of 8-12,
  • Continuing ambulation (Vignos Scale Stage 1-4),
  • Volunteering to participate in the study by parents and reading and signing the informed consent form.

Критерии исключения

  • Having another neuromuscular disease diagnosed other than DMD and/or accompanying DMD,
  • Having family and/or child having cooperation problems in completing the evaluations for any reason,
  • Lack of internet infrastructure or technical infrastructure that may cause difficulty in continuing distance education/follow-up,
  • Having difficulty in understanding and speaking the Turkish language.

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

Turkey (Türkiye) · 1 центр
  • Lokman Hekim University — Ankara

Идентификаторы

NCT: NCT06643923 · 2024232 · Lokman hekim university

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗