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Идёт набор NCT06449495

Virtual Reality for Pediatric Motor Rehabilitation.

Без фазы С лечением Coordination and Balance Disturbances

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: NIRVANA.
Кому может быть актуально
Состояния в реестре: Coordination and Balance Disturbances. Базовые параметры: 4 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Treatment of Balance and Coordination Disorders in the Pediatric Population With the Virtual Reality System Nirvana.

Обзор

Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living in pediatric population. There are several systems that can be used to treat balance and coordination disorders and those that use virtual reality, such as NIRVANA, are becoming increasingly popular. The primary objective of this post-market clinical investigation is to evaluate the efficacy of the semi-immersive virtual reality platform NIRVANA (BTS Bioengineering), in accordance with the protocol defined at IRCCS Medea in Bosisio Parini, in children with balance and coordination disorders on both motor function and cognitive processes that are indirectly stimulated.

Подробное описание

Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living.

Among the various conditions commonly associated with balance and gait deficits in the pediatric population, neurological diseases represent an important subgroup, as do neurodevelopmental disorders. Children with balance and coordination problems typically have difficulty walking independently and manifest a gait characterized by an enlarged base of support and are generally prone to frequent falls.

Coordination deficits also result in a reduction in the fluidity of functional gestures with a consequent negative impact on quality of life.

Not only that, in the presence of the above-mentioned problems, psycho-motor retardation is also often evident in children, consequently presenting cognitive, relational and learning problems as well.

There are several systems that can be used to treat balance and coordination disorders; in particular, those that use virtual reality systems such as NIRVANA are becoming increasingly popular. This device has been used in subjects with neurological disorders (Stroke, Parkinson's, and Multiple Sclerosis) with good results in both motor and visuocognitive areas. To date there are still few studies of this device in the pediatric setting, although its effectiveness in both autism spectrum disorders and global developmental delays is beginning to be explored.

The primary objective of this post-market clinical investigation is to evaluate the efficacy, in the context of its intended use, of the semi-immersive virtual reality platform NIRVANA (BTS Bioengineering), in accordance with the protocol defined at IRCCS Medea in Bosisio Parini, in children with balance and coordination disorders on both motor function and cognitive processes that are indirectly stimulated. Additional objective is to confirm the safety of the device, with the possibility of detecting any emerging risks with respect to expected performance. Secondary objective is to identify guidelines for use in clinical practice of the NIRVANA device with respect to pediatric populations undergoing treatment. Patients undergo a combined rehabilitation treatment consisting of 20 sessions with Nirvana and 20 sessions of physiotherapy (age \>7aa) or psychomotor therapy (age \<=7aa) over four weeks for a total of 40 sessions. The same subjects undergo clinical-functional assessments before and at the end of treatment:

* Stabilometry to assess balance with defined protocol on GAIT (BTS) platforms * GMFM-88 o PBerg * Continuous Performance Test (CPT or KCPT) sustained attention assessment test.

Вмешательства

  • Устройство NIRVANA
    NIRVANA is a medical device using semi-immersive virtual reality for motor and cognitive neuro-rehabilitation. NIRVANA creates a "sensory room" where the patient can have an immersive and stimulating experience by interacting directly with different realistic scenarios. The system creates different scenarios on the wall or floor, and the patient interacts with the stimuli provided. A motion-analysis device detects the patient's behavior and based on the projected environment provides highly sti

Первичные конечные точки

  • Stabilometry with force platforms [Срок оценки: T0(pre-training),T1 (after 4 weeks of training)]
  • Gross Motor Function Measure-88 (GMFM-88) [Срок оценки: T0(pre-training),T1 (after 4 weeks of training)]
  • Pediatric Berg Balance Scale (PBBS) [Срок оценки: T0(pre-training),T1 (after 4 weeks of training)]
Вторичные конечные точки (1)
  • Continuous Performance Test (CPT or KCPT) [Срок оценки: T0(pre-training),T1 (after 4 weeks of training)]

Критерии участия

Критерии включения

  • balance or coordination disorders of different etiology: tumor, post-traumatic, neurodegenerative, syndromic, congenital, or associated with neurodevelopmental delay. - - - age between 4 and 17 years
  • independent ambulation
  • ability to understand simple verbal instructions.

Критерии исключения

  • adult
  • wheelchair-bound
  • major cognitive and behavioural problems.

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

Италия · 3 центра
  • Irccs Eugenio Medea — Bosisio Parini
  • Irccs Eugenio Medea — Conegliano
  • Associazione "La Nostra Famiglia" - Polo Ospedaliero di Neuroriabilitazione, Piazza Di Sum — Brindisi

Идентификаторы

NCT: NCT06449495 · GIP 1061

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗