Intensive Physiotherapy in Children Affected by Posterior Fossa Tumors
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: intensive physiotherapy.
- Кому может быть актуально
- Состояния в реестре: Posterior Fossa Tumor. Базовые параметры: 0 лет — 25 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 →
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Официальное название
Intensive Physiotherapy Intervention in Children Affected by Tumors Located in Posterior Cranial Fossa
Обзор
The objective of the current study is to describe the effectiveness of conventional and intensive physiotherapeutic intervention in improving gross motor skills (i.e. postural changes, walking and balance skills) in children affected by posterior fossa tumors
Подробное описание
The surgery aimed to remove tumors located in the cranial posterior fossa can lead, as a consequence, to a clinical condition of ataxia.
Children affected by this condition are commonly referred to physiotherapy treatment, even though the level of scientific evidence in the field of motor rehabilitation is still lacking.
The objective of the current study is to describe the effectiveness of conventional and intensive physiotherapeutic intervention in improving gross motor skills (i.e. postural changes, walking and balance skills) in children affected by posterior fossa tumors.
By conventional physiotherapy intervention we mean a therapeutic path with a 1:1 operator-patient ratio and which does not make use of robotic or virtual reality devices.
By intensive we mean that it occurs twice a day, 5 days a week, for a duration of four weeks.
Given the high variability in the severity of the clinical pictures, the primary objective will be the patient's improvement in gross motor skills as a whole, which will be identified with the Gross Motor Function Measurment (GMFM) scale.
Changes will also be monitored with respect to the autonomy and assistive care in the daily life of the recruited patients (scored through WeeFIM or FIM), the risk of fall (scored through the Pediatric Balance Scale) and with a sign-specific scale on ataxia (Scale for Assessment and Rating of Ataxia) Finally, for walking patients, walking resistance will be assessed through the 6 minute walking test (6MWT)
Вмешательства
- Процедура intensive physiotherapy
the dosing of the intensive physiotherapy is of 2 sessions a day, lasting 45 minutes each, administered 5 days a week, for a period of 4 weeks. the physiotherapy is mainly addressed to the improvement of gross motor movement and balance and the training is designed according to the specific need of the subject recruited. it is not allowed the use of technological devices, excepted treadmill training.
Первичные конечные точки
- Gross Motor Function Measure (GMFM) [Срок оценки: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
Вторичные конечные точки (5)
- Six minutes walking test (6MWT) [Срок оценки: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
- Scale for the Assessment and Rating of Ataxia (SARA) [Срок оценки: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
- Pediatric Balance Scale (PBS) [Срок оценки: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
- WeeFIM [Срок оценки: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
- gait analysis [Срок оценки: A first assessment is provided at the enrollment and the second assessment is administered at the end of the treatment, after 4 weeks]
Критерии участия
Критерии включения
- subjects who underwent to surgical resection of tumors located in posterior fossa, age between 0 and 25 years
Критерии исключения
- Subjects that are currently addressed to rehabilitative protocols availing of technological devices
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 3 центра
- IRCCS E. Medea — Brindisi
- IRCCS E. Medea — Bosisio Parini
- IRCCS E. Medea — Conegliano
Идентификаторы
NCT: NCT06832384 · 21.2022 Oss