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Набор по приглашению NCT07664878

AR-Based Motor Rehabilitation for Children With CP

Без фазы С лечением Cerebral Palsy (CP) Augmented Reality Exercise Program

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: AR-based therapy, Conventional physical therapy.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy (CP), Augmented Reality Exercise Program. Базовые параметры: 6 лет — 15 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
Чехия
Следующий шаг
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Официальное название

Digitalization of Rehabilitation Care for Children With Motor Disorders Using Augmented Reality Technologies

Обзор

The aim of the project is to create a digital system for cognitive-oriented rehabilitation of the central neuromuscular diseases (CND) with the use of augmented reality (AR) technology in children. Solving the project supports the professional-oriented digital literacy of professionals in rehabilitation institutions in the Czech Republic (CR). With the applied research, the software will be developed for the training of fine and gross motor skills, postural control and walking in the AR environment for children with cerebral palsy and verified in the practice of professionals in rehabilitation. The project aims to modernization and increase of the effectiveness of the work of professionals in rehabilitation institutions in the CR. The project is based on an interdisciplinary approach.

Вмешательства

  • Поведенческое AR-based therapy
    The child wore Meta Quest 3 (Meta Platforms, Menlo Park, California, USA) VR/AR goggles during the exercises. Our custom exercise applications were running on the device. They provide brief verbal instructions at the start of each exercise. During the exercise, they also give short cognitive prompts to support focused attention.
  • Поведенческое Conventional physical therapy
    Traditional spa treatment comprising hydrotherapy and physical therapy.

Первичные конечные точки

  • Speed of 10-meter walk test (m/s) [Срок оценки: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Cadence (steps/min) [Срок оценки: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Support phase (% cycle) [Срок оценки: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Swing Phase (% Cycle) [Срок оценки: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Symmetry index of pelvic tilt [Срок оценки: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Symmetry index of pelvic obliquity [Срок оценки: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Symmetry index of pelvic rotation [Срок оценки: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • The Pediatric balance scale (PBS) [Срок оценки: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
Вторичные конечные точки (1)
  • One-Leg Balance (valuated by the time the child is able to maintain the position) [Срок оценки: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]

Критерии участия

Критерии включения

  • Medical diagnosis of spastic hemiparesis or diparesis types cerebral palsy
  • The level of motor skills was at levels I and II according to the Gross Motor Function Classification System (GMFCS)
  • spasticity of grade 2 or less diagnosed with the Modified Ashworth Scale (MAS)
  • Ability to walk at least 10 meters without aids and without the support of a therapist

Критерии исключения

  • no neurological disease other than CP
  • no visual impairment with exception of short-sightedness
  • Children is not able to follow instructions during testing and training
  • Injection treatment of anti-spastic medication in the last 3 months
  • Lower limb surgery within the past 12 months

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

Чехия · 1 центр
  • Palestra — Prague

Идентификаторы

NCT: NCT07664878 · TQ01000031

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗