Exoskeleton-Assisted Mobility in Aging and in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCentre intégré de santé et de services sociaux de l'Outaouais
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Exoskeleton
DeviceThe 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.
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: ConditionsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Timed Up and Go (TUG) duration
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.
Time frame
Through intervention completion, on average one hour2
Changes in 10 meters walk test (10MWT) walking speed
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.
Time frame
Through intervention completion, on average one hour3
Changes in 5 repetitions sit-to-stand test (5STS) duration
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.
Time frame
Through intervention completion, on average one hourSecondary outcomes
1
Changes in gait variability
The Mobilise-D algorithm will be used to quantify step length variability during the 1-minute 10MWT.
Time frame
Through intervention completion, on average one hour2
Exoskeleton acceptability (qualitative data, before exoskeleton use)
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.
Time frame
Baseline3
Changes in exoskeleton acceptability (qualitative data, post exoskeleton use compared to pre)
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).
Time frame
Immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov