Меню
Идёт набор NCT04640584

C-Brace Prospective Registry

— Наблюдательное Pareses Lower Extremity

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: C-Brace.
Кому может быть актуально
Состояния в реестре: Pareses, Lower Extremity. Базовые параметры: Без ограничений · 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, Австралия, Германия, Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Prospective Registry of Patients Fitted With a Microprocessor-controlled Knee Ankle Foot Orthosis

Обзор

To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.

Подробное описание

The purpose of the C-Brace Prospective Registry is to gather prospective baseline and follow-up data to characterize the safety and effectiveness of the C Brace. Patients casted for C-Brace fitting and willing to provide informed consent at participating clinics will be enrolled in the registry. All patients will be followed in accordance with the standard of care for a C-Brace, which will include, at a minimum, baseline evaluation, fitting, patient training/therapy sessions, follow-up at 6 months, 12 months, 24 months and 36 months after the definitive fitting of the C-Brace.

Вмешательства

  • Устройство C-Brace
    The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.

Первичные конечные точки

  • Primary Efficacy: Timed Walk Test [Срок оценки: Change in walking speed with the C-Brace measured either by a 25-ft or 10-m walk test compared to baseline measurements when assessed 12 months after initial fitting]
  • Primary Efficacy: Timed Up and Go (TUG) Test [Срок оценки: Changes in mobility, balance, risk of falling, and walking ability as measured by TUG test with the C-Brace system compared to baseline when assessed 12 months after the initial fitting.]
  • Primary Efficacy: Activities-specific Balance Confidence (ABC) [Срок оценки: Changes in perceived balance confidence as assessed by the ABC score with the C-Brace system compared to baseline when assessed 12 months after the initial fitting.]
  • Primary Safety: Frequency and severity of falling [Срок оценки: Changes in numbers of device-related adverse events experienced by C Brace users by frequency and severity compared to baseline measurement when assessed 12 months after the initial fitting]
Вторичные конечные точки (3)
  • Patient Specific Functional Scale (PSFS) [Срок оценки: Changes in patient-centered activities and in the defined activity performance with C-Brace by the PSFS compared to baseline when assessed 12 months after the initial fitting.]
  • Activity Tracker [Срок оценки: Changes of C-Brace utilization at 12 months compared to baseline measurement estimated by the activity tracker]
  • Berg Balance Scale (BBS) [Срок оценки: Changes in static and dynamic balance abilities as measured by the BBS compared to baseline when assessed 12 months after initial fitting with C-Brace.]

Критерии участия

Критерии включения

  • Patient has been evaluated and successfully tested with the Trial Tool, and has been casted for a C-Brace.
  • Patient is able to communicate, provide feedback, understand and follow instructions during the course of the registry.
  • Patient is willing to provide informed consent.

Критерии исключения

  • Patient is geographically inaccessible to comply and participate in the registry.
  • Patient has not been casted for a C-Brace fitting.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 70 центров
  • Jonesboro P&O x Ottobock.care — Harrison
  • Jonesboro P&O x Ottobock.care — Rogers
  • Bionics Orthotics & Prosthetics — San Diego
  • ABI P&O — San Diego
  • West Coast Brace & Limb - Palm Harbor — Palm Harbor
  • Hanger - Sarasota — Sarasota
  • West Coast Brace & Limb - Tampa — Tampa
  • ProCare Prosthetics x Ottobock.care — Buford
  • … и ещё 62 центра
Германия · 4 центра
  • Pohlig BmbH — Traunstein
  • Ottobock Göttingen — Göttingen
  • John+Bamberg GmbH & Co. KG — Hanover
  • Katholisches Klinikum Koblenz-Montabaur — Koblenz
Австралия · 1 центр
  • Neuromuscular-orthotics.com.au — Clayton
Япония · 1 центр
  • Hyogo Rehabilitation Hospital — Kobe

Публикации

  • Lundstrom RL, Klenow TD, Morris A, Pobatschnig B, Hibler KD, Kannenberg AH. The C-Brace(R) microprocessor controlled stance and swing orthosis improves safety, mobility, and quality of life at one year: Interim results from a prospective registry. J Rehabil Assist Technol Eng. 2024 Aug 9;11:20556683241269539. doi: 10.1177/20556683241269539. eCollection 2024 Jan-Dec. PMID 39132469

Идентификаторы

NCT: NCT04640584 · PD-PS00120018A-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗