Em-power: Maximizing Functional Independence for Children With Severe Cerebral Palsy

Обзор

For children with severe cerebral palsy, a powered wheelchair (PWC) may provide their only option for functional mobility and independence. PWC use is often restricted to a small percentage of children who can quickly demonstrate proficient PWC skills within a single 30-minute PWC trial. This 2-arm, parallel group, single blinded, pre-test-post-test randomized controlled trial will test our hypothesis that an 8-week PWC skills training intervention will produce greater improvements in children's PWC skills capacity immediately after the intervention and at an 8-week follow-up assessment.

Вмешательства

• Другое Power wheelchair skills training using the IndieTrainer system
  The IndieTrainer system will be used to provide the power wheelchair (PWC) skills training sessions. The IndieTrainer is comprised of a mobility device and an array of video-based gamified training modules designed to facilitate PWC training. The IndieTrainer mobility device temporarily converts a manual wheelchair into a powered wheelchair, thereby allowing children to remain in their own manual wheelchair and use their own custom seating system during power wheelchair skills training activitie

Первичные конечные точки

• Change in understanding how to use a power wheelchair [Срок оценки: Baseline (T0) pre-intervention, immediately after the conclusion of the 8-week intervention period (T1), and at the single session retention trial 8 weeks after the end of the intervention period (T2)]
• Change in power wheelchair skill performance [Срок оценки: Baseline (T0) pre-intervention, immediately after the conclusion of the 8-week intervention period (T1), and at the single session retention trial 8 weeks after the end of the intervention period (T2)]

Вторичные конечные точки (2)

• Change in parental/caregiver perceptions of changes in their children's performance of power wheelchair skill performance [Срок оценки: Baseline (T0) pre-intervention and immediately after the conclusion of the 8-week intervention period (T1)]
• Change in children's perceptions of changes in their performance of power wheelchair skill performance [Срок оценки: Baseline (T0) pre-intervention and immediately after the conclusion of the 8-week intervention period (T1)]

Критерии участия

Критерии включения

• Diagnosis of severe CP (Gross Motor Function Classification System Level IV or V)
• Inability to functionally walk or functionally propel a manual wheelchair as assessed by the Principal Investigator a licensed physical therapist
• Demonstrate cause and effect skills in the IndieTrainer consistent with an Assessment of Learning Powered mobility use (ALP Assessment) Phase 4 or higher (i.e., understand that they are moving the IndieTrainer using the switch(es) or joystick) as assessed by the Principal Investigator, a licensed physical therapist.
• In addition, one parent/caregiver must be conversant in English and be able to provide their child's medical and health history and be willing to take on the parent participant role.

Критерии исключения

• The inability to sit in their own manual wheelchair or adaptive stroller for 60 minutes (as this would preclude them safely using the IndieTrainer System for the 60-minute intervention sessions)
• Their manual wheelchair or adaptive stroller cannot be safely used with the IndieTrainer System
• They already have an individually prescribed power wheelchair
• If the Principal Investigator, a licensed physical therapist, determines that based on the child's medical and health history, that they cannot safely participate in power wheelchair skills training.

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Grand Valley State University — Grand Rapids

Идентификаторы

NCT: NCT06347432 · 24-119-H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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