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

May 11, 2026 updated by: Centre intégré de santé et de services sociaux de l'Outaouais

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Timed Up and Go (TUG) duration
Time Frame: 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.
Through intervention completion, on average one hour
Changes in 10 meters walk test (10MWT) walking speed
Time Frame: 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.
Through intervention completion, on average one hour
Changes in 5 repetitions sit-to-stand test (5STS) duration
Time Frame: 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.
Through intervention completion, on average one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in gait variability
Time Frame: Through intervention completion, on average one hour
The Mobilise-D algorithm will be used to quantify step length variability during the 1-minute 10MWT.
Through intervention completion, on average one hour
Exoskeleton acceptability (qualitative data, before exoskeleton use)
Time Frame: 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.
Baseline
Changes in exoskeleton acceptability (qualitative data, post exoskeleton use compared to pre)
Time Frame: 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).
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre intégré de santé et de services sociaux de l'Outaouais

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-266

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized quantitative data collected from this study will be published alongside scientific articles and deposited in a recognized public research data repository.

IPD Sharing Time Frame

The anonymized quantitative dataset will become available upon completion of the study and once results have been published in an academic journal (anticipated year of publication: 2027).

IPD Sharing Access Criteria

The anonymized quantitative dataset will be published alongside scientific articles and deposited in a recognized public research data repository. These anonymized data may be accessible without time limit.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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