Parkinson's Disease (PD), Healthy Aging
Conditions
Keywords
Exoskeleton, Mobility, Rehabilitation, Parkinson's Disease, Walking, Balance, Risk of falls
Brief summary
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.
Detailed description
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.
Interventions
DEVICEExoskeleton
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 3 Nm, respectively, for each of these parameters. A minimum assistance of 1 Nm per parameter will be maintained when the baseline preferred assistance level is low. During condition 5, the exoskeleton will be set to free mode, meaning that no assistance will be provided, but motor resistance will be eliminated.
Sponsors
Centre intégré de santé et de services sociaux de l'Outaouais
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Participants are blinded to the level of assistance provided by the exoskeleton (i.e., blinded to conditions 2, 3, 4 and 5)
Intervention model description
A group of healthy older adults and a group of individuals with Parkinson's disease will each undergo this single trial arm of this study which consists of 6 conditions, each corresponding to a different exoskeleton assistance level (without x2, preferred assistance, low assistance, high assistance, free assistance).
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
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, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Timed Up and Go (TUG) duration | Through intervention completion, on average one hour | Participants will be required to stand up from a chair, walk 3 meters, turn around, return to the chair, and sit down. The time will be measured between the starting signal ("go") and the moment the participant is seated again. TUG is a reliable test to assess fall risk. |
| Changes in 10 meters walk test (10MWT) walking speed | Through intervention completion, on average one hour | This test involves walking at a natural pace along a 10-meter segment, continuously for a duration of 1 minute. The first and last meters of the segment are used to allow for the 180° turn and are not included in the analysis. The choice of a continuous 1-minute protocol was made in accordance with current recommendations to ensure the validity and reliability of gait measurements using accelerometers. |
| Changes in 5 repetitions sit-to-stand test (5STS) duration | Through intervention completion, on average one hour | The sit-to-stand test assesses the participant's ability to rise from a chair without using the arms. The participant sits with feet flat on the floor and legs shoulder-width apart, then stands up while keeping the arms crossed over the chest. The time required to complete five repetitions is recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in gait variability | Through intervention completion, on average one hour | The Mobilise-D algorithm will be used to quantify step length variability during the 1-minute 10MWT. |
| Exoskeleton acceptability (qualitative data, before exoskeleton use) | Baseline | A descriptive qualitative thematic analysis will be conducted following Braun and Clarke approach on qualitative data obtained during the first semi-structured interview (before exoskeleton use). A coding tree will be developed in which each unit of meaning will be assigned a label (i.e., a code). These codes will then be grouped into categories from which the key themes will emerge. This is a semi-inductive analytic process in which themes from the interview guide will serve as the basis for the initial coding, with additional codes added as they emerge from the interview content. Categories and themes will be discussed within the research team until consensus is reached. |
| Changes in exoskeleton acceptability (qualitative data, post exoskeleton use compared to pre) | Immediately after the intervention | A descriptive qualitative thematic analysis will be conducted following Braun and Clarke approach on qualitative data obtained during the second semi-structured interview (after exoskeleton use). A coding tree will be developed in which each unit of meaning will be assigned a label (i.e., a code). These codes will then be grouped into categories from which the key themes will emerge. This is a semi-inductive analytic process in which themes from the interview guide will serve as the basis for the initial coding, with additional codes added as they emerge from the interview content. Categories and themes will be discussed within the research team until consensus is reached, and will be compared to those obtained following the first semi-structured interview (pre exoskeleton use). |
Countries
Canada
Contacts
CONTACTAlexandra Potvin-Desrochers, PhD
CONTACTLucas Michaud, PhD
Outcome results
None listed