Exoskeleton-Assisted Mobility in Aging and in Parkinson's Disease: A Mixed-Methods Study of Effectiveness and Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Participants are blinded to the level of assistance provided by the exoskeleton (i.e., blinded to conditions 2, 3, 4 and 5)
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with Parkinson's disease
- •Inclusion Criteria:
- •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
排除标准
- •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
- •Inclusion Criteria:
- •Ability to walk for at least 30 minutes with or without minimal aid
- •Age ≥ 65 years old
- •Exclusion Criteria:
- •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
研究组 & 干预措施
Conditions
The effect of the exoskeleton on mobility will be evaluated under six different conditions: (1) without the exoskeleton (pre), (2) preferred assistance, (3) low assistance, (4) high assistance, (5) neutral assistance, and (6) without the exoskeleton (post). The order of conditions 2 to 5 will be randomized. All participants will undergo all six conditions.
干预措施: Exoskeleton (Device)
