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Идёт набор NCT06454656

A Motor Learning Intervention to Target Walking Performance in Ambulant Children With Cerebral Palsy

Без фазы С лечением Cerebral Palsy Walking, Difficulty Spastic Diplegia Hemiplegic Cerebral Palsy

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: MOBILE.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy, Walking, Difficulty, Spastic Diplegia, Hemiplegic Cerebral Palsy. Базовые параметры: 6 лет — 17 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
Ирландия
Следующий шаг
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Официальное название

A "MOtor Learning Based Intervention for Lower Extremities (MOBILE)" to Target Walking Performance in Ambulant Children With Cerebral Palsy: A Feasibility Study

Обзор

The goal of this clinical trial is to learn if a new therapy approach to improve walking ability in children with Cerebral Palsy is acceptable to the children and the families in a community setting. The main questions we look to answer are: 1. Do the children/teens tolerate the therapy and feel that it is helpful? 2. Do the parents/ families feel the therapy helps and is easy to commit to? 3. Do the children/teens complete all their therapy sessions and assessments as planned? The participants will trial the therapy for 30 hours over 6 weeks and will perform assessments before and after to see if they meet their goals. They will also be interviewed to see how they felt about the therapy when they finish.

Подробное описание

The therapy being trialed in this study uses motor learning theory to try and improve or change walking patterns to improve the child/teen's walking goal.

Therapy will target their own walking goal and they can choose the format of their therapy as long as they complete 30 hours of which 24 hours must be in the clinic within a 6 week period.

Вмешательства

  • Другое MOBILE
    Intensive motor learning based intervention to target specific walking goals as identified using the Gait Outcome Assessment List. Full Protocol outlining strategies available on request. Three key principles underpin the intervention: Principle 1: The type of task Principle 2: The type of practice Principle 3: The type of Feedback

Первичные конечные точки

  • Recruitment Rate [Срок оценки: rolling recruitment over 1.5 years]
  • Adherence to Intervention [Срок оценки: Duration of study 2 years]
  • Retention [Срок оценки: Duration of study 2 years]
  • Adverse Events [Срок оценки: Duration of study 2 years]
  • Fidelity to Intervention Protocol [Срок оценки: Duration of study 2 years]
  • Feasibility of Outcome Measures (Participant) [Срок оценки: Duration of study 2 years]
  • Feasibility of Outcome Measures (Assessor) [Срок оценки: Duration of study 2 years]
  • Acceptability of Intervention [Срок оценки: Duration of study 2 years]
  • Time taken to complete Outcome Measures [Срок оценки: Duration of study 2 years]
Вторичные конечные точки (6)
  • Gait Outcome Assessment List [Срок оценки: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years]
  • 6 minute walk test [Срок оценки: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years]
  • 10 meter self-selected walking speed [Срок оценки: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years]
  • Modified timed up and go [Срок оценки: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years]
  • ankle and knee Range of motion [Срок оценки: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years]
  • Child Health Utilities Index CHU-9D [Срок оценки: baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years]

Критерии участия

Критерии включения

  • Primary diagnosis of Cerebral Palsy (GMFCS Levels I-III)
  • Has a specific walking related goal
  • Has capacity to follow instruction
  • Has a primary caregiver who can support a home program

Критерии исключения

  • Has had surgery within 6 months of intervention start date
  • Has had botox/ baclofen within 3 months of intervention start date
  • Has a dual diagnosis that impacts ability to follow instruction
  • Has a significant cognitive impairment

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
Лечение

Центры проведения

Ирландия · 1 центр
  • Enable Ireland Bangla Therapy Centre — Balrath

Идентификаторы

NCT: NCT06454656 · 23-163

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗