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Идёт набор NCT07252713

Complex Rehabilitation Technology Enabled Physical Activity for Children With Motor Delays Via Telehealth in Natural Environments

Без фазы С лечением Cerebral Palsy (CP) Motor Disability Motor Delay

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: Stander Use.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy (CP), Motor Disability, Motor Delay. Базовые параметры: 1 год — 6 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The primary goal of CP-MOVES is to evaluate 1) the preliminary efficacy of a telehealth-delivered, parent coaching intervention in the use of adaptive standers, on physical activity, sleep, and endurance in young children with severe motor delays and 2) on physical activity, sedentary time, resting heart rate, and perceived stress in parents. The main questions the study aims to answer include: 1. Do measures of physiological fitness and sleep in children with severe motor delays (i.e., unable to stand without support) change after a therapist-directed, parent-delivered intervention using telehealth and adaptive standers? 2. Do parents report any changes in their child's endurance, participation, or quality of life OR parent stress following intervention? Children ages 1-6 years old with severe motor delay and one parent will: 1. Complete three 30 minute sessions of standing in an adapted stander per week for 8 weeks. One session per week will be completed with a physical therapist, delivered through telehealth and two sessions per week will be completed as a home program with the parent and child (no therapist or telehealth). 2. Wear activity tracker sensors on the wrist(s) and waist for one-week before and after treatment. 3. Complete questionnaires about the child's endurance, participation, and quality of life and the parent's stress, before and after treatment. 4. Complete an assessment of postural control before and after treatment. 5. Complete an post-treatment interview

Вмешательства

  • Поведенческое Stander Use
    The intervention includes 8 weeks of adaptive standing training delivered via telehealth with PT parent-coaching (1 telehealth session/week + 2 parent-led practice sessions/week). Sessions are 30 minutes, 3x/ week. Participants are provided a stander, sized to their age and body size for use during the study.

Первичные конечные точки

  • Wearable sensor physical activity data: Vector Magnitude [Срок оценки: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.]
  • Wearable sensor physical activity data: Daily Activity Counts [Срок оценки: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.]
  • Wearable sensor physical activity data: Average Resting Heart Rate [Срок оценки: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.]
  • Wearable sensor physical activity data [Срок оценки: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.]
  • Sleep wearable sensor data: total sleep time [Срок оценки: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.]
  • Sleep wearable sensor data: Sleep Latency [Срок оценки: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.]
  • Sleep wearable sensor data: Sleep efficiency [Срок оценки: For 7 days before 8 week intervention begins and 7 days after 8-week intervention ends.]
Вторичные конечные точки (8)
  • Caregiver Priorities and Child Health Index of Life with Disabilities (CP-CHILD) [Срок оценки: before and after 8-week intervention]
  • Young Child-Participation in Environment Measure (YC-PEM) [Срок оценки: Before and after 8-week treatment]
  • The Early Activity Scale for Endurance (EASE) [Срок оценки: Before and after 8 week treatment]
  • Perceived Stress Scale-14 (PSS-14) [Срок оценки: Before and after 8-week treatment period]
  • Segmental Assessment of Trunk Control (SATCO) [Срок оценки: Before and after 8-week intervention]
  • Reaching Assessment [Срок оценки: During treatment weeks 1, 2, 7, 8]
  • Parent Interview [Срок оценки: within 2 weeks of end of 8 week treatment period]
  • Parenting Sense of Competence Scale-Revised [Срок оценки: Before and after 8-week intervention]

Критерии участия

Критерии включения

  • Child age 1-6 years with CP or other severe motor delay (GMFCS IV-V);
  • Unable to stand without external support;
  • Parent willing and able to participate;
  • Internet access for telehealth;
  • Live within 50 miles of lab or willing to travel to OSU for pre and post testing and stander provision
  • One parent is fluent in English.

Критерии исключения

  • Inability to participate in telehealth
  • Parent/caregiver unable to participate

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

США · 1 центр
  • Pediatric Assessment and Rehabilitation Lab — Columbus

Идентификаторы

NCT: NCT07252713 · STUDY20251878

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗