Upright Participation for Learners: Implementation of Flexible Use of roboT-assisted Walking in Schools - PILOT

Официальное название

Upright Participation for Learners: Implementation of Flexible Use of roboT-assisted Walking in Schools

Обзор

Robot-assisted walking offers children who are unable to walk new avenues for participation in their communities in addition to health benefits. Disappointingly, most children cannot access this impactful technology. One of every 1000 children cannot walk due to cerebral palsy,1 and many others cannot walk due to less common neurodevelopmental disorders such as Spina Bifida or Rett Syndrome. The inability to walk impacts most areas of daily life. Despite this large need, there are few, if any, interventions available to facilitate participation and motor function.2-4 Recently, the study team have learned that robot-assisted walking can improve motor function and reduce the health impacts of physical inactivity that these children often experience. Robot assisted walking aids attach to a walker and use robotic legs to power a child's leg movements, allowing them to use their body in new ways from an upright position. When used in home and community settings, it also creates new avenues for participation in daily life that are critical for supporting cognitive, communication and social development. However, this technology is expensive and requires adult support, limiting access to families with adequate resources. The need exists to create equitable opportunities to access robot-assisted walking to improve multidimensional outcomes for children who cannot walk. Many innovative rehabilitation interventions do not cross the chasm from evidence to implementation. Knowing this risk, this program is strategically using implementation science methods to identify and study strategies to support implementation. Through previous studies, school settings have been identified as optimal for facilitating equitable access to robot-assisted walking to promote participation and function-based improvements. The research team conducted a study to identify barriers and facilitators to implementation in a school setting and have subsequently selected strategies to address the barriers and leverage the facilitators. Before confidently launching a planned multisite trial to examine implementation and effectiveness of robot-assisted walking in the school setting, the research team needs to pilot the implementation strategies within the planned study design. The proposed pilot study will optimize research methods to ensure a future multisite trial provides the necessary evidence for sustainable school implementation and equitable access to robot-assisted walking.

Вмешательства

• Устройство Robotic walking
  Use of a robotic walking aid will be provided to participants by qualified school therapists and staff

Первичные конечные точки

• the Consolidated Framework for Implementation Research (CFIR) [Срок оценки: From the date of enrollment until the date of completion of both study arms, up to 12 months.]

Вторичные конечные точки (2)

• Early Clinical Assessment of Balance (ECAB) [Срок оценки: From the date of enrollment until the date of completion of both study arms, up to 12 months.]
• Canadian Occupational Performance Measure (COPM) [Срок оценки: From the date of enrollment until the date of completion of both study arms, up to 12 months.]

Критерии участия

Критерии включения

• Enrolled at a participating study site.
• Fit a robotic walking device.

Критерии исключения

• Does not fit a robotic walking device.
• Displays a contraindication to robotic walking.

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

Двойное слепое

Основная цель

Оценка устройства

Центры проведения

Канада · 1 центр

• University of Calgary — Calgary

Идентификаторы

NCT: NCT07726706 · REB24-0305 · REB24-0305

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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