Activities-based Locomotor Training in Children With Cerebral Palsy

Официальное название

Efficacy of Activities-based Locomotor Training in Children With Cerebral Palsy.

Обзор

This project aims to improve the quality of life and functional outcomes for young non-ambulatory children with Cerebral Palsy (CP) by investigating the efficacy of an Activities-Based Locomotor Training (AB-LT) program compared to usual care. By targeting the body structures, activities, and participation components of the World Health Organization's International Classification of Functioning, Disability, and Health (ICF) framework, this study seeks to enhance our understanding of neuroplasticity and motor learning in this population, offering a novel approach to rehabilitation. Results from this research will lead to more effective, individualized therapies that improve motor function, reduce disability, and ultimately lower the long-term healthcare needs associated with CP.

Вмешательства

• Другое Activities-based locomotor training
  Activities-based locomotor training involves placing the child in a partial body-weight supported (PBWS) system over a treadmill. The child is given assistance by trained clinicians to attempt standing and walking on the treadmill for 1 hour. The child then participates in play-based activities aimed to foster independence in an overground (regular) environment for 1 hour. The final hour of the 3-hour session is conducted in the PBWS system with a focus on standing and walking.
• Другое physical therapy
  In this intervention, the child will attend their usual physical therapy sessions.

Первичные конечные точки

• Gross Motor Function Measure (GMFM-66) [Срок оценки: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.]

Вторичные конечные точки (2)

• functional near infrared spectroscopy (fNIRS) [Срок оценки: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.]
• Child Engagement in Daily Life (CEDL) [Срок оценки: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.]

Критерии участия

Inclusion Criteria: To be eligible for this study, the child must be:

• • Able to hold their head upright for 5 seconds when supported at the trunk in sitting (the minimal amount of head control necessary for safe walking on the partial body weight support system during the AB-LT intervention);

• Non-ambulatory or not walking as primary means of mobility;
• Willing to attend the AB-LT intervention at Fortis Therapy Center in Dripping Springs, Texas for 3 hours/ day, 5 days/week, for 3 weeks; and
• Willing to commit to a total of 7 weeks of the study, and to continue their usual care during the time period in which they are not enrolled in the AB-LT intervention.

Exclusion Criteria: The child must not have:

• • Surgery or botulinum toxin injections in the previous 6 months;

• Uncontrolled epilepsy; and
• Uncontrolled cardiovascular disease

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

Лечение

Центры проведения

США · 1 центр

• Fortis Therapy Center — Dripping Springs

Идентификаторы

NCT: NCT07184411 · 2245497 · 1R15HD119622-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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