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Набор скоро начнётся NCT06894160

Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases

Без фазы С лечением Neuromuscular Disorders

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: Adults EXPLORER.
Кому может быть актуально
Состояния в реестре: Neuromuscular Disorders. Базовые параметры: 18 лет — 85 лет · 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
Испания
Следующий шаг
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Официальное название

Safety and Usability of Adults EXPLORER Exoskeleton in With Neuromuscular Diseases

Обзор

Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. EXPLORER is a robotic exoskeleton for gait rehabilitation, specifically designed for adults aged 18 to 85 with motor disabilities.The aim of this study is to evaluate the safety and usability of the EXPLORER for adults with motor disability.

Подробное описание

Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. EXPLORER is a robotic exoskeleton for gait rehabilitation, specifically designed for adults aged 18 to 85 with motor disabilities. The aim of this study is to evaluate the safety and usability of the EXPLORER for adults with motor disability.

This study will involve testing the gait-assistance exoskeleton in healthy patients during the first phase, and in patients with stroke (ACV), acquired brain injury (DCA), multiple sclerosis (EM), and muscular dystrophy (LM) during the second phase. The study will consist of two phases:

Phase 1: One visit with the device in healthy patients to assess the initial safety and comfort of the device.

Phase 2: A screening visit (S0) followed by two treatment visits with the device (V1-V2) in patients with ACV, DCA, EM, and LM to determine the effectiveness of the device in treating motor impairments caused by these conditions.

The goal of the study is to evaluate the safety and usability of the device in patients with ACV, DCA, EM, and LM, in order to identify potential benefits in improving gait, muscle strength, and overall functionality in this patient group.

Вмешательства

  • Устройство Adults EXPLORER
    Two sessions with the robotic gait device in patients with neuromuscular diseases.

Первичные конечные точки

  • Serious Adverse Events [Срок оценки: Through study completion, an average of 1 month]
  • Falls prevalence [Срок оценки: Through study completion, an average of 1 month]
  • Heart Rate [Срок оценки: Through study completion, an average of 1 month]
  • Skin integrity [Срок оценки: Through study completion, an average of 1 month]
  • Device usage time [Срок оценки: Through study completion, an average of 1 month]
  • Level of Spasticity [Срок оценки: Through study completion, an average of 1 month]
  • Level of fatigue [Срок оценки: Through study completion, an average of 1 month]
  • Donning and doffing time [Срок оценки: Through study completion, an average of 1 month]
  • Level of assistance a participant requires for walking [Срок оценки: Through study completion, an average of 1 month]
  • Walking ability of individuals with spinal cord injuries [Срок оценки: Through study completion, an average of 1 month]

Критерии участия

Inclusion criteria related to the device characteristics:

  • Weight < 100 kg.
  • Hip width between 30 - 45 cm.
  • Distance from the hip joint center to the knee joint center: 36 cm - 50 cm.
  • Distance from the knee joint center to the floor: 43.5 cm - 59.5 cm.
  • Patients must be able to follow simple instructions.
  • MAS < 3 in lower limbs.
  • EU shoe size between 36 and 45.
  • Absence of pathology affecting movement (only valid for phase 1 of the current study).

Inclusion criteria related to the study:

  • Age 18-85 years.
  • Diagnosis of stroke (ACV), acquired brain injury (DCA), multiple sclerosis (EM), muscular dystrophy (LM), or cerebral palsy (PC).
  • Gait difficulty: those who require assistance to walk using technical aids, assistance, or supervision from others.
  • FAC score in participants with DCA, stroke, or MS < 4.
  • WISCI II score in participants with MD < 20.

Критерии исключения

  • Spasticity (MAS) = 3 in lower limbs.
  • Skin alterations in the areas of contact with the device.
  • Planned surgical intervention during the study duration.
  • Two or more osteoporotic fractures in the lower limbs in the last 2 years.
  • Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe lung disease).
  • Surgical operation in the 3 months prior to the start of the study on the limbs and/or spine.
  • Psychiatric disorders that interfere with proper use of the device or participation in the study, such as impulsivity or inability to understand simple instructions.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Hospital Universitario La Paz — Madrid

Идентификаторы

NCT: NCT06894160 · EXP-A-US

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗