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Идёт набор NCT07134049

Sensory Integration Therapy in Children With Congenital Brachial Plexus Injury: Developmental Outcomes

Без фазы С лечением Obstetric Brachial Plexus Injury

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: sensory integration therapy.
Кому может быть актуально
Состояния в реестре: Obstetric Brachial Plexus Injury. Базовые параметры: 7 мес. — 35 мес. · 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Investigation of the Effects of Sensory Integration Therapy on Sensory, Motor, and Cognitive Development in Children With Congenital Brachial Plexus Injury

Обзор

The purpose of this study is to investigate the effectiveness of sensory integration therapy in reducing sensory, motor, and cognitive developmental impairments following Congenital Brachial Plexus Injury (CBPI), and to support the overall developmental processes of affected children.

Подробное описание

Detailed Description:

Congenital Brachial Plexus Injury (CBPI) is a peripheral nerve injury occurring during childbirth that can lead to varying degrees of sensory, motor, and functional impairments. These impairments may adversely affect not only motor skills but also sensory processing and cognitive development, particularly in early childhood when neurodevelopment is highly plastic. Sensory integration therapy is a child-centered, play-based intervention designed to improve the brain's ability to process and integrate sensory information from the tactile, vestibular, proprioceptive, visual, and auditory systems. By providing enriched and graded sensory experiences, this therapeutic approach aims to promote adaptive responses, improve motor planning, enhance self-regulation, and support overall developmental progress.

The purpose of this study is to evaluate the effectiveness of sensory integration therapy in reducing sensory, motor, and cognitive developmental impairments in children with CBPI aged 7 to 35 months. Participants in the intervention group will receive individualized sensory integration therapy sessions once a week for 8 weeks, in addition to their routine physiotherapy programs. Developmental outcomes will be assessed using standardized assessment tools before and after the intervention. The findings of this study are expected to contribute to evidence-based rehabilitation approaches for children with CBPI and to inform early intervention strategies aimed at optimizing sensory, motor, and cognitive development.

Вмешательства

  • Другое sensory integration therapy
    Sensory Integration Therapy (SIT) is a client-centered rehabilitation approach aimed at improving adaptive and functional responses to sensory stimuli in changing environments. It is based on structured, individualized activities conducted in enriched sensory environments. These environments are designed to be engaging and motivating for children through the use of interactive and playful tasks that match their sensory processing profiles. Sensory integration plays a key role in motor planning,

Первичные конечные точки

  • Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) [Срок оценки: The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.]
Вторичные конечные точки (3)
  • Dunn Infant/Toddler Sensory Profile (7-35 months) [Срок оценки: The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.]
  • Active Movement Scale (AMS) [Срок оценки: The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period]
  • Modified Mallet Grading System (MMGS) [Срок оценки: he assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.]

Критерии участия

Критерии включения

Confirmed diagnosis of obstetric brachial plexus injury (OBPI) Age between 7 and 35 months No additional diagnosed neurological, psychiatric, and/or muscular disorders No diagnosed mental retardation or cognitive disorder that would prevent participation in assessments Written informed consent from parents or legal guardians

Критерии исключения

Severe visual or hearing impairment preventing participation in assessments Participation in another experimental rehabilitation program within the last 3 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
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Hacettepe Univeristy — Ankara

Идентификаторы

NCT: NCT07134049 · E-68552689-000-00004173157 · Hacettepe University

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗