Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy

Официальное название

Agilik@Home: Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy

Обзор

The goal of this clinical trial is to learn if a two month training with the Agilik powered orthosis improves the knee extension or the endurance in pediatric patients with Cerebral palsy and a crouch gait. It will also learn about the safety of Agilik. The main questions it aims to answer are: Does the Agilik powered orthosis increase the value of the knee extension during walking? What medical problems do participants have when using the Agilik powered orthosis? Researchers will compare a group of patients using the Agilik powered exoskeleton with a group of patients treated with standard therapy. Participants will: Use Agilik at home or perform standard therapy for 2 months Visit the clinic at the beginning of the study, after 3 months and after 1 additional month.

Вмешательства

• Устройство Powered orthosis
  Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.

Первичные конечные точки

• Endurance [Срок оценки: Baseline, 3 months and 4 months]
• Knee extension in mid stance (KEMS) [Срок оценки: Baseline, 3 months and 4 months]

Вторичные конечные точки (9)

• Measurements of the Joint range of motions (ROMs) and muscle lengths [Срок оценки: Baseline, 3 months and 4 months]
• Level of spasticity in the lower limbs [Срок оценки: Baseline, 3 months and 4 months]
• Walking speed [Срок оценки: Baseline, 3 months and 4 months]
• Postural and motor abilities [Срок оценки: Baseline, 3 months and 4 months]
• Gait pattern [Срок оценки: Baseline, 3 months and 4 months]
• Self-perception of performance in everyday living [Срок оценки: Baseline, 3 months and 4 months]
• Static balance [Срок оценки: Baseline, 3 months and 4 months]
• Usability and acceptability of the powered orthosis [Срок оценки: After the treatment only in the intervention group]
• Behavioural engagement [Срок оценки: After the treatment only in the intervention group]

Критерии участия

Критерии включения

• Diagnosis of CP and a crouch gait
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.
• Body weight between 20 and 125 Kg
• Knee flexion retraction assessed in supine position by less than 10°. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
• Subjects must not have had a tibio-tarsal arthrodesis. In addition, they must have at least 5° of passive dorsi-flexion of the ankle.
• Able to walk at least 3 m without stopping, with or without a walking aid.
• Able to understand and follow simple directions based on parent report and physician observation during historical and physical examination.
• GMFCS level I, II and III
• MAS score ≤ 2

Критерии исключения

• Any severe neurological, musculoskeletal and/or cardiorespiratory involvement preventing the ability to walk;
• A history of uncontrolled seizure in the past year
• Severe spasticity
• Hip and/or knee flexion contracture of more than 20°

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

Открытое

Основная цель

Лечение

Центры проведения

Италия · 6 центров

• IRCCS E. MEDEA - Associazione "La Nostra Famiglia" — Bosisio Parini
• IRCCS Fondazione Stella Maris — Calambrone
• Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente — Milan
• Fondazione Mondino — Pavia
• Fondazione Don Carlo Gnocchi Onlus — Roma
• Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare — Salerno

Публикации

• Nossa R, Storm FA, Diella E, Riboni R, Molteni LE, Chiappini M, Maghini C, Beretta E, Nicotra R, Abbondio S, Ferrante C, Cotardo A, Sgherri G, Germanotta M, Mauro MC, Fasano A, Cordoni C, Ferrarin M, Cavallini A, Signorini SG, Sgandurra G, Aprile I, Iuvone L, Cavalagli A, Biffi E; Agilik@home Study Group. Agilik@home: A randomized controlled trial protocol to evaluate the effects of home-based tra PMID 41880375

Идентификаторы

NCT: NCT06622655 · GIP1122 · PNC0000007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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