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Набор скоро начнётся NCT06552819

User Experience of a Gait Training Treadmill for Home Rehabilitation of Children With Chronic Conditions

— Наблюдательное Chronic Diseases in Children

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: No intervention.
Кому может быть актуально
Состояния в реестре: Chronic Diseases in Children. Базовые параметры: 8 лет — 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

"In the context of limited accessibility to prolonged and efficient rehabilitation programs based on physical activity, this study aims to develop a home program for children with chronic diseases affecting physical health (including cerebral palsy, obesity, and neuromuscular diseases). The French company EzyGain has designed a compact treadmill equipped with sensors and a safety system, which communicates with a tablet application and a virtual reality headset to support at-home rehabilitation. This study seeks to advance the development of this solution into a prolonged and progressive training program, tailored to positively impact children's health. Future users, including children, their parents, and therapists, will be at the heart of the development process. A qualitative methodology will be employed, incorporating focus groups and a series of user experience (UX) questionnaires. The research hypothesis is that user feedbacks will enable the development of an appropriate solution that meets their specific needs and ensures high adoption rates of the device. This study is the first step before assessing the impact of the solution in these 3 groups of children (with cerebral palsy, obesity and neuromuscular disease)."

Подробное описание

"Visit 1: Children, accompanied by one of their parents, will test the treadmill and the associated rehabilitation games on a tablet and in immersive virtual reality in its current version, and UX questionnaires will be administered.

Visit 2: Children, parents, and therapists, in groups of 6 to 8, will participate in focus groups during which they will express their opinions regarding the solution they tested in Visit 1 and discuss areas for improvement.

(several monthsare dedicated to the developpement of the solution by the society, based on the children, parents and therapists' feedbacks)

Visit 3: Children, accompanied by one of their parents, will test the treadmill and the associated rehabilitation games on a tablet and in immersive virtual reality in its new version, and UX questionnaires will be administered."

Вмешательства

  • Другое No intervention
    No intervention

Первичные конечные точки

  • Focus group outputs [Срок оценки: Between the second and third week]
Вторичные конечные точки (6)
  • User Experience Questionnaire (UEQ-S) [Срок оценки: Day 1 and 6 months]
  • Usability Metric for User Experience (UMUX) [Срок оценки: Day 1 and 6 months]
  • Ease with technology [Срок оценки: Day 1 and 6 months]
  • Cybersickness [Срок оценки: Day 1 and 6 months]
  • Children's perception of the games [Срок оценки: Day 1 and 6 months]
  • Acceptability [Срок оценки: Day 1 and 6 months]

Критерии участия

"Inclusion Criteria for the children:

  • aged between 8 and 18 years old
  • capable of walking during 5 minutes on a treadmill with or without walking aid, and with or without body weight support
  • diagnosis of one the following pathology: bilateral cerebral palsy, obesity, spinal muscular amiotrophy type 3, Duchenne, congenital myopathy, Charcot Marie Tooth
  • Gross Motor Function Classification System (GMFCS) I to III for the children with cerebral palsy
  • IMC superior to the centile IOTF-30 for the children with obesity
  • Functionnal level of 2 to 6 on the Walton scale, or 3 to 7 on the Vignos scale for the children with neuromuscular disease

Inclusion Criteria for the parents:

\- parent of an eligible child

Inclusion Criteria for the therapists:

\- Therapist of at least one eligible child

Inclusion Criteria for all:

  • Able to express oneself and respond to a questionnaire in French
  • Formulate their non-opposition to participate in the research

Критерии исключения

  • Deprived of liberty by judicial or administrative decision
  • Subject to a legal protection measure"

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • CHU Angers — Angers

Идентификаторы

NCT: NCT06552819 · 49RC24_0261

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗