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Набор скоро начнётся NCT07487857

Intensive Somatosensory Camp for Manual Function and Participation in Children With Unilateral Cerebral Palsy

Без фазы С лечением Cerebral Palsy

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: Somatosensory-Motor Intensive Camp, Motor-Only Intensive Camp.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy. Базовые параметры: 5 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Intensive Somatosensory Camp for Manual Function and Participation in Children With Unilateral Cerebral Palsy: a Randomnized Controlled Trial

Обзор

This study will evaluate whether an intensive day camp that combines somatosensory and motor training for the affected upper limb improves hand function and participation in children with unilateral cerebral palsy more than an intensive motor-only camp of equal duration and intensity. Children aged 5 to 15 years with unilateral spastic cerebral palsy and Manual Ability Classification System (MACS) levels I-III will be randomly assigned to one of two intervention groups. The experimental group will receive an 8-day, 40-hour camp including structured tactile, proprioceptive and vestibular stimulation integrated into meaningful functional tasks for the upper limb. The control group will receive an 8-day, 40-hour camp focused exclusively on intensive motor training without specific somatosensory stimulation. The primary outcome is the change in spontaneous bimanual performance of the affected hand, measured with the Assisting Hand Assessment (AHA). Secondary outcomes include measures of unilateral upper limb function, somatosensory function, hand grip strength, gross motor function, balance, trunk control, participation in daily activities and objective upper limb activity measured with wrist-worn accelerometers. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up visits approximately 2 and 3 months after the camp.

Подробное описание

Unilateral cerebral palsy is a common cause of motor disability in childhood and is frequently associated with somatosensory impairments of the affected upper limb, such as reduced tactile discrimination, impaired proprioception and difficulties with object recognition by touch. These sensory deficits contribute to learned non-use of the affected hand and limited spontaneous bimanual performance in daily activities, even when basic motor abilities are present. Intensive upper limb therapies, such as constraint-induced movement therapy and bimanual training, have shown positive effects on hand function, but most programs focus primarily on motor components and do not systematically target somatosensory function.

This randomized, controlled, single-blind clinical trial will compare two parallel intensive day-camp interventions for children with unilateral spastic cerebral palsy. Both groups will receive 40 hours of therapy over 8 consecutive days (5 hours per day) in a group-based camp format. The experimental group will participate in a structured somatosensory-motor program that integrates tactile, proprioceptive and vestibular stimulation within play-based, goal-oriented upper limb activities and functional workshops. Daily sessions include sensory activation (e.g., tactile massage, exploration of different textures), intensive tactile discrimination and haptic tasks (e.g., object recognition without vision, graded textures, vibration), and integration of somatosensory input into functional tasks and postural control activities (e.g., balance exercises on unstable surfaces, tasks with light weights).

The control group will receive an intensive motor-focused camp with the same total dose, schedule and therapist supervision. Activities will target active range of motion, strength, coordination, and functional use of the affected upper limb through standard manual tasks (such as reaching, grasping, building with blocks, threading, and fine motor games) and gross motor upper limb exercises and circuits, without structured somatosensory stimulation.

The primary objective is to determine whether the somatosensory-motor camp produces greater improvements in spontaneous bimanual performance of the affected hand, assessed by the Assisting Hand Assessment (AHA), compared with the motor-only camp. Secondary objectives include examining changes in unilateral upper limb movement quality (e.g., Melbourne Assessment of Unilateral Upper Limb Function), detailed somatosensory function (e.g., standardized assessments of tactile perception, two-point discrimination, proprioception and stereognosis), grip strength, gross motor function and balance, trunk control, participation and goal attainment, as well as objective upper limb activity recorded by wrist accelerometry in and outside the camp setting. Assessments will be conducted at baseline (T0), immediately after the intervention (T1, after 8 days) and at follow-up visits approximately 2 and 3 months after the camp.

The study is designed as a minimal-risk pediatric rehabilitation trial and follows ethical and data protection regulations. Randomization will be centralized, and outcome assessors and data analysts will be blinded to group allocation.

Вмешательства

  • Поведенческое Somatosensory-Motor Intensive Camp
    Structured 8-day intensive rehabilitation camp (40 hours total, 5 hours/day) for children with unilateral cerebral palsy. Integrates somatosensory stimulation (tactile massage, texture discrimination, vibration therapy, proprioceptive exercises, vestibular/balance activities) within functional upper limb motor tasks, play-based workshops, and bimanual activities targeting spontaneous hand use and participation in daily activities.
  • Поведенческое Motor-Only Intensive Camp
    Structured 8-day intensive rehabilitation camp (40 hours total, 5 hours/day) focused exclusively on upper limb motor training for children with unilateral cerebral palsy. Includes active range of motion exercises, grip strength training, fine motor coordination tasks (grasping, threading, block manipulation), reaching/coordination circuits without structured somatosensory stimulation.

Первичные конечные точки

  • Assisting Hand Assessment (AHA) [Срок оценки: Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)]
Вторичные конечные точки (9)
  • Melbourne Assessment of Unilateral Upper Limb Function Version 2 (MA-2) [Срок оценки: Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)]
  • Somatosensory Function (SWM, 2PD, Stereognosis) [Срок оценки: Baseline (T0), immediately after intervention (T1, 8 days), follow-up at one month (T2)]
  • Hand Grip Strength (Jamar Dynamometer) [Срок оценки: Baseline (T0), immediately after intervention (T1, 8 days), follow-up at one month (T2)]
  • Upper Limb Activity (Wrist Accelerometry) [Срок оценки: Baseline (T0), during daily life in camps days, immediately after intervention (T1, 8 days), follow-up at one month (T2)]
  • Participation (COPM, PEM-CY) [Срок оценки: Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)]
  • GMFM-66 (Gross Motor Function Measure-66 Item Set) [Срок оценки: Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)]
  • Pediatric Balance Scale (PBS) [Срок оценки: Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)]
  • Trunk Control Measurement Scale (TCMS-S) [Срок оценки: Baseline (T0), immediately after intervention (T1, 8 days), follow-up at 1 month (T2)]
  • Children's Hand-use Experience Questionnaire (CHEQ [Срок оценки: Baseline (T0), immediately after intervention (T1, 8 days)]

Критерии участия

Критерии включения

  • diagnosis of spastic CP
  • aged between 5 and 15 years of age
  • able to follow simple verbal instructions and complete all the necessary tests according to their ages
  • MACS level I-III

Критерии исключения

  • uncontrolled epilepsy episodes in the 6 months prior to the start of the study
  • botulinum toxin in the last 6 months
  • orthopedic or neurological surgery in the 12 months prior to the start of the study or scheduled during the intervention development period
  • visual or cognitive disabilities that interfere with treatment
  • unable to actively participate in the activities

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07487857 · CAMPUSENS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗