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Идёт набор NCT04997109

Telemedicine in Early Childhood Constraint Therapy in 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: APPLES-tele, Parent-centered Approach (PCA) Support Intervention, Standard of Care.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy. Базовые параметры: 4 мес. — 13 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.

Подробное описание

Cerebral palsy (CP) is a disorder characterized by impairments of sensorimotor function resulting from neural insults in the perinatal period. Every year almost 10,000 children are born with CP in the US. CP incidence ranges from 2 to 3 per 1000 in North America, Australia, and Europe and is difficult to estimate in the developing world. Intervention strategies to promote function of children with CP must be adaptable to settings where resources or access may be limited, yet simultaneously integrate best clinical evidence and neuroscientific principles. Upper extremity (UE) impairments are present in a significant portion of children with CP, some with hemiplegia (\~25% children with CP), and others with quadriplegia, in which one arm and hand may be more affected than the other (another \~25%). UE impairments in CP result from a combination of motor and sensory dysfunctions including a lack of high-quality motor experience, which combined with "noisy" (often faulty) sensory input, challenges the acquisition of new effective motor patterns.

Among the various approaches to improve UE function in infants with CP are constraint-induced movement therapy (the use of constraints on less affected limbs) and bimanual therapy (training of both extremities in coordination). Brief sessions of parent-delivered, infant-initiated, goal-directed, success-motivated and repetitive activity in enriched sensory environments can be effective, while respecting fundamental principles of infant development and home life. Parent administration of the intervention helps preserve the integrity of early parent-child relationships, critical to establishment of infants' sense of self, safety, and independence.

Finally, to take full advantage of neuroplasticity and maximize potential downstream developmental effects, it is essential to intervene as early as possible in children with CP. Promising new treatments such as transcranial magnetic stimulation, robotic-assisted movements and technology enhancements to movement feedback are in development. However, these interventions require substantial investments of highly-skilled therapists, technology, infrastructure and access to academic facilities. While the new interventions advance the cutting-edge of motor intervention development, on another leading edge, parent-delivered therapist-directed telehealth interventions are becoming more widespread, addressing a critical need for lower-resource interventions.

Healthcare systems resources are limited, and can be difficult to access due to geographic and socioeconomic obstacles. While telehealth therapy seems eminently practical, and a natural extension of current interventions for infants with CP, it faces its own scientific challenges. The same essential attributes of physical therapy that make it so effective in person can make it difficult to deliver via telehealth. Telehealth therapy in infants requires a level of parent engagement, knowledge and parenting skills that is sometimes lacking. Feasible telehealth interventions to improve function in infants with CP must also address the challenges faced by their parents in conducting the sessions through effective parenting supports.

In this study, infant participants with CP will be randomized to one of three treatment groups:

1. The APPLES intervention via telehealth (APPLES-tele) followed by a parent-centered approach (PCA) intervention 2. The PCA intervention followed by the APPLES-tele intervention 3. The standard of care

Outcome measures will be standardized assessments of hand/arm function and validated parent-report measures of infant motor activity.

Вмешательства

  • Другое APPLES-tele
    The APPLES-tele intervention is 5 weekly telehealth sessions of therapist-demonstrated tasks, delivered over a 6 week period. Infant participants wear a soft-constraint harness (C-Mitt) on their less affected arm for 6 hours per day, while their parent encourages them to use their more affected arm to complete play-based activities as instructed by the study therapist. As the infant experiences success, heavier objects are provided. During times when the C-Mitt is not worn, parents engage therap
  • Поведенческое Parent-centered Approach (PCA) Support Intervention
    The PCA support intervention is 5 weekly telehealth sessions delivered over a 6 week period. The PCA curriculum includes 5 basic principles of positive parenting from Triple P: ensuring a safe engaging environment, creating a positive learning environment, using assertive discipline, having reasonable expectations, and looking after yourself as a parent. All of these elements, when taught to parents in an individualized manner, can help promote responsivity, structure and expectations that are t
  • Поведенческое Standard of Care
    Participants will receive the usual care from being followed in high-risk infant follow-up (HRIF) programs in the Early Detection and Intervention (EDI) Network.

Первичные конечные точки

  • Change in Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score [Срок оценки: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)]
  • Change in Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score [Срок оценки: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)]
Вторичные конечные точки (5)
  • Change in Infant Motor Activity Log (IMAL) How Often Score [Срок оценки: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)]
  • Change in Hand Assessment in Infants (HAI) Score [Срок оценки: Baseline, Week 6 (after the first intervention)]
  • Change in Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score [Срок оценки: Baseline, Week 6 (after the first intervention)]
  • Change in Welch Emotional Connection Screen (WECS) Score [Срок оценки: Baseline, Week 6 (after the first intervention)]
  • Change in Maternal Confidence Questionnaire (MCQ) Score [Срок оценки: Baseline, Week 6 (after the first intervention)]

Критерии участия

Критерии включения

  • Aged 4 to 13 months, corrected age
  • Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (>95% risk of later CP)
  • Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of greater than or equal to 2 and/or neuroimaging consistent with perinatal involvement
  • Hand Assessment for Infants (HAI) difference between hands ≥2, with an observable and relative difference in quality or amount of movement between hands, as determined by HAI-certified study therapists and/or a unimanual Bayley score difference between hands >1
  • Parent/legal guardian is able to provide informed consent

Критерии исключения

  • Congenital malformation of the brain or musculoskeletal system (MSK)
  • Receipt of botulinum toxin to the affected extremity within 3 months of study entry
  • Any prior long-term hard constraint programs

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 4 центра
  • Emory University — Atlanta
  • Kennedy Krieger Institute — Baltimore
  • Children's Hospital of Philadelphia — Philadelphia
  • The University of Utah — Salt Lake City

Идентификаторы

NCT: NCT04997109 · STUDY00003197 · 2R01HD081120

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗