Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population

Обзор

In 2019, approximately 2.4 billion people worldwide required rehabilitation for various health pathologies, a 63% increase since 1990. It has been suggested that current rehabilitation frameworks (inpatient, outpatient, and community-based) are insufficient to meet local population needs due to issues like long waiting times, lack of facilities, prioritization, funding, and accessibility.Patients with lower limb weaknesses, resulting from various conditions (for example stroke, traumatic brain injury, spinal cord injury and others) require long-term management and motivation for engagement, which are crucial for functional outcomes. This highlights the need for sustainable gait and balance rehabilitation. New technologies like exoskeletons have shown promising results in short-term inpatient programs, improving gait, balance, and quality of life, however, long-term follow-up data are still needed. The present clinical investigation is a national, prospective, open-label interventional trial, proposing a 12-month outpatient rehabilitation program with the Atalante X exoskeleton to treat lower limb weakness and/or impairments in 100 participants. The rehabilitation program consists of at least one exoskeleton rehabilitation session per week. At the end of the first-year experimental phase, participants can continue for an additional year in the voluntary phase. The program aims to explore the potential long-term effects of supervised robotic rehabilitation on motor, cognitive, bowel, bladder functions, quality of life, and well-being. Assessments are conducted at baseline, after 4 and 12 months of exoskeleton rehabilitation, and at 16 and 24 months for participants in the voluntary phase.

Вмешательства

• Устройство Hands-free exoskeleton
  During the one-year intervention period, participants will complete at least one exoskeleton session per week (≥36 sessions) with the Atalante X. The additional voluntary year follows the same design. During sessions with the exoskeleton, the patients will perform ambulatory exercises with the device, with a gradual increase of intensity through the sessions.

Первичные конечные точки

• Function in Sitting Test [Срок оценки: At baseline, at 4 and 12 months; at 16 and 24 months]

Вторичные конечные точки (12)

• 10-meter walk test [Срок оценки: At baseline, at 4 and 12 months; at 16 and 24 months]
• Modified Clinical Test of Sensory Integration in Balance [Срок оценки: At baseline, at 4 and 12 months; at 16 and 24 months]
• Timed Up and Go [Срок оценки: At baseline, at 4 and 12 months; at 16 and 24 months]
• Functional Independence Measure [Срок оценки: At baseline, at 4 and 12 months; at 16 and 24 months]
• 6-minute walk test [Срок оценки: At baseline, at 4 and 12 months; at 16 and 24 months]
• A five-step clinical assessment of spasticity [Срок оценки: At baseline, at 4 and 12 months; at 16 and 24 months]
• Biering-Sorensen test [Срок оценки: At baseline, at 4 and 12 months; at 16 and 24 months]
• Muscle strength [Срок оценки: At baseline, at 4 and 12 months, at 16 and 24 months]
• Montreal Cognitive Assessment [Срок оценки: At baseline, at 4 and 12 months; at 16 and 24 months]
• Adverse events monitoring [Срок оценки: Through study completion, up to 24 months for each participant]
• Modified Borg Rating of Perceived Exertion [Срок оценки: At baseline, at 4 and 12 months, at 16 and 24 months]
• System Usability Scale [Срок оценки: At baseline, at 4 and 12 months; at 16 and 24 months]

Критерии участия

Критерии включения

• Patient suffering from lower limb weaknesses and / or deficiencies regardless of the cause
• Adult patient ≥18 years old
• Patient able to read and write in French and who have signed an informed consent form
• Patient affiliated to a social security system.

Критерии исключения

• Individual with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score of 4 on the modified Ashworth scale
• Pregnant woman
• Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis
• Pressure Ulcer of Grade I or higher according to the NPUAP International Pressure Ulcer Classification System- EPUAP, in areas of contact with the Atalante X system
• Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
• Patient with a cardiac or respiratory contraindication to physical exertion, at discretion of the physician
• Patient unable to deliver his/her consent
• Patient under legal protection
• Patient participating at the same time in another study
• Patients with morphological contraindications to the use of the Atalante X exoskeleton (as per user's manual) with exceptions as follows: knee flessum of 20° authorized if sensibility is present; equinus of the ankle of 20° allowed regardless of presence or absence of sensibility, hip flessum of 20° allowed regardless of presence or absence of sensibility.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Wandercraft — Paris

Публикации

• Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1. PMID 33275908
• Eldar R, Kullmann L, Marincek C, Sekelj-Kauzlaric K, Svestkova O, Palat M. Rehabilitation medicine in countries of Central/Eastern Europe. Disabil Rehabil. 2008;30(2):134-41. doi: 10.1080/09638280701191776. PMID 17852214
• Kamenov K, Mills JA, Chatterji S, Cieza A. Needs and unmet needs for rehabilitation services: a scoping review. Disabil Rehabil. 2019 May;41(10):1227-1237. doi: 10.1080/09638288.2017.1422036. Epub 2018 Jan 5. PMID 29303004

Идентификаторы

NCT: NCT06538974 · CIP005 ALERT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗