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Идёт набор NCT07567482

Exoskeleton-Assisted Mobility in Aging and in Parkinson's Disease

Без фазы С лечением Parkinson's Disease (PD) Healthy Aging

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: Exoskeleton.
Кому может быть актуально
Состояния в реестре: Parkinson's Disease (PD), Healthy Aging. Базовые параметры: от 50 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Exoskeleton-Assisted Mobility in Aging and in Parkinson's Disease: A Mixed-Methods Study of Effectiveness and Acceptability

Обзор

This study will evaluate whether a wearable robotic exoskeleton can improve mobility, balance, and walking in healthy older adults and in individuals living with Parkinson's disease, populations at high risk of falls and mobility limitations. Participants will attend two laboratory sessions. The first session includes clinical assessments, fitting and familiarization with the exoskeleton, and interviews to explore user perceptions. The second session involves performing functional mobility tasks (e.g., walking, standing, turning) with and without the exoskeleton and under different assistance levels, while movement is measured using wearable sensors. The study will assess the immediate effects of the exoskeleton on mobility, compare assistance levels, identify which participants benefit most, and explore user experience and acceptability. Findings will help inform the development and implementation of assistive technologies to support mobility in healthy aging and in individuals with Parkinson's disease.

Подробное описание

Age-related declines in balance and walking ability increase the risk of falls, a leading cause of injury, loss of independence, and reduced quality of life among older adults. These challenges are even more pronounced in people living with Parkinson's disease, a neurological condition that affects movement and further impairs gait and postural stability. Although medications and rehabilitation can provide some benefit, mobility limitations often persist. Wearable exoskeletons have emerged as a promising approach to improve walking and reduce effort; however, their effectiveness and acceptability in individuals with Parkinson's disease remain insufficiently understood, particularly in real-world functional tasks.

The primary objective of this study is to determine the immediate effect of using a mobility-assistive exoskeleton on objective measures of balance and gait in healthy older adults and in individuals living with Parkinson's disease, and to explore user experience and acceptability.

The specific objectives are to: 1) Identify participant profiles (e.g., sex, age, severity of balance and gait impairments, severity of Parkinson's disease) that benefit the most from exoskeleton use, 2) Compare the effects of different levels of exoskeleton assistance on objective mobility measures relative to each participant's preferred assistance level, in order to determine whether this preferred level corresponds to the most effective level of assistance, 3) Determine whether the use of the exoskeleton improves balance and gait parameters, 4) Describe the perceptions of healthy older adults and in individuals with Parkinson's disease regarding the use of an exoskeleton in daily life, with particular attention to their interest, perceived benefits, barriers, and concerns related to its use, and 5) Explore how perceptions of exoskeleton use in daily life may change following a supervised exoskeleton use experience.

The study will be conducted in a laboratory setting and will take place over two separate sessions spaced at least two days and no more than four days apart. The first session will involve fitting and familiarizing participants with the exoskeleton, as well as conducting baseline clinical assessments (general health, mobility, balance, physical activity level, fatigue, mood, and cognitive function). During this session, participants will also undergo two semi-structured interviews, one before and one after using the exoskeleton, to share their perceptions, expectations, and concerns about using an exoskeleton.

During the second session, participants will perform a series of functional mobility tests both with and without the exoskeleton. When testing mobility with the exoskeleton, levels of assistance will manipulated to determine whether more or less support leads to better performance, and whether a participant's preferred level of assistance is also the most effective. Kinematics data will be collected using accelerometers to measure detailed aspects of walking, such as speed, step length, and variability.

For participants with Parkinson's disease, data collection will be conducted during the optimal effect of their usual dopaminergic medication, corresponding to the "ON" state.

The findings from this study will help determine whether exoskeletons are a useful and acceptable tool to support mobility in older adults and people with Parkinson's disease. In the long term, this research could contribute to the development of new strategies to reduce fall risk, improve independence, and enhance quality of life. It may also help guide healthcare professionals and technology developers in designing and implementing mobility aids that better meet the needs of these populations.

Вмешательства

  • Устройство Exoskeleton
    The exoskeleton assistance in condition 2 will correspond to the preferred assistance level determined during the first session using an iterative approach. For conditions 3 and 4, four exoskeleton parameters will be adjusted: eccentric load assistance, concentric load assistance, assistance during lower-limb flexion in the swing phase, and assistance during lower-limb extension in the swing phase. The increased and decreased assistance conditions will correspond to an increase and a decrease of

Первичные конечные точки

  • Changes in Timed Up and Go (TUG) duration [Срок оценки: Through intervention completion, on average one hour]
  • Changes in 10 meters walk test (10MWT) walking speed [Срок оценки: Through intervention completion, on average one hour]
  • Changes in 5 repetitions sit-to-stand test (5STS) duration [Срок оценки: Through intervention completion, on average one hour]
Вторичные конечные точки (3)
  • Changes in gait variability [Срок оценки: Through intervention completion, on average one hour]
  • Exoskeleton acceptability (qualitative data, before exoskeleton use) [Срок оценки: Baseline]
  • Changes in exoskeleton acceptability (qualitative data, post exoskeleton use compared to pre) [Срок оценки: Immediately after the intervention]

Критерии участия

Participants with Parkinson's disease

Критерии включения

  • Ability to walk for at least 30 minutes with or without minimal aid
  • Diagnosis of idiopathic Parkinson's disease
  • Hoehn and Yahr stage 1 to 4

Критерии исключения

  • Height smaller than 152 cm
  • Severe vascular conditions of the lower limbs that may limit mobility or pose a risk.
  • Presence of any implantable or external life-sustaining medical device such as a pacemaker
  • Severe osteoporosis or high risk of fractures
  • Contra-indication to the required physical effort
  • Severe cognitive impairment (MoCA < 21)
  • Presence of neurological disorders, lower-limb injuries, or other conditions interfering with mobility, other than Parkinson's disease.

Healthy elderly participants without Parkinson's disease

Критерии включения

  • Ability to walk for at least 30 minutes with or without minimal aid
  • Age ≥ 65 years old

Критерии исключения

  • Height smaller than 152 cm
  • Severe vascular conditions of the lower limbs that may limit mobility or pose a risk.
  • Presence of any implantable or external life-sustaining medical device such as a pacemaker
  • Severe osteoporosis or high risk of fractures
  • Contra-indication to the required physical effort
  • Severe cognitive impairment (MoCA < 21)
  • Presence of neurological disorders, lower-limb injuries, or other conditions interfering with mobility

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
Поддерживающая терапия

Центры проведения

Канада · 1 центр
  • TechCare Research Lab - CISSS de l'Outaouais — Gatineau

Идентификаторы

NCT: NCT07567482 · 2026-266

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗