Parkinson's Disease (PD)NCT07567482
Exoskeleton-Assisted Mobility in Aging and in Parkinson's Disease
A study testing Exoskeleton in people with Parkinson's Disease (PD) and Healthy Aging, run by Centre intégré de santé et de services sociaux de l'Outaouais at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease (PD), Healthy Aging
- What is being tested?
- Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 30 Apr 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Ability to walk for at least 30 minutes with or without minimal aid
- Age ≥ 65 years old
Who cannot join
- 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)
Show all 15Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandra Potvin-Desrochers, PhD contact
Canada1 site, 1 recruiting
- Recruiting
TechCare Research Lab - CISSS de l'Outaouais
Gatineau, Quebec, J9H 3Z1
Alexandra Potvin-Desrochers, PhD, 819-966-6200 ext. 335671, alexandra.potvin-desrochers@ssss.gouv.qc.ca
Lucas Michaud, PhD, 819-966-6200 ext. 338067, 07.labotechsoins@ssss.gouv.qc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson's Disease (PD), Healthy Aging
- Being tested
- Exoskeleton
- Keywords
- Exoskeleton, Mobility, Rehabilitation, Parkinson's Disease, Walking, Balance, Risk of falls
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoskeletonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conditions | Experimental | 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. Receives: Device: Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through intervention completion, on average one hour
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.
Measured: Through intervention completion, on average one hour
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.
Measured: Through intervention completion, on average one hour
Secondary outcomes (3)
Changes in gait variability
The Mobilise-D algorithm will be used to quantify step length variability during the 1-minute 10MWT.
Measured: Through intervention completion, on average one hour
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.
Measured: Baseline
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).
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start30 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre intégré de santé et de services sociaux de l'Outaouais
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567482
- Sponsor's protocol ID
- 2026-266
- Status last verified
- May 2026
- First submitted
- 17 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized quantitative data collected from this study will be published alongside scientific articles and deposited in a recognized public research data repository.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exoskeleton-Assisted Mobility in Aging and in Parkinson's Disease: A Mixed-Methods Study of Effectiveness and Acceptability
- ClinicalTrials.gov ID
- NCT07567482
- Acronym / sponsor ID
- 2026-266
- Conditions
- Parkinson's Disease (PD), Healthy Aging
- Keywords
- Exoskeleton, Mobility, Rehabilitation, Parkinson's Disease, Walking, Balance, Risk of falls
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Centre intégré de santé et de services sociaux de l'OutaouaisOther government
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Conditions | Experimental | Device: ExoskeletonThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Ability to walk for at least 30 minutes with or without minimal aid
- Age ≥ 65 years old
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExoskeletonThe 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. | Device | Conditions |
Primary outcome
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.
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.
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.
3 secondary outcomes
Changes in gait variability
Time frame: Through intervention completion, on average one hour
Exoskeleton acceptability (qualitative data, before exoskeleton use)
Time frame: Baseline
Changes in exoskeleton acceptability (qualitative data, post exoskeleton use compared to pre)
Time frame: Immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. Anonymized quantitative data collected from this study will be published alongside scientific articles and deposited in a recognized public research data repository.
Related trials for Parkinson's Disease (PD)
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingObservational study
Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation
Parkinson Disease
Not yet recruiting
Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Potvin-Desrochers, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton in people with Parkinson's Disease (PD) and Healthy Aging, run by Centre intégré de santé et de services sociaux de l'Outaouais at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Potvin-Desrochers, PhD (819-966-6200 ext. 335671, alexandra.potvin-desrochers@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Timed Up and Go (TUG) duration (time frame: Through intervention completion, on average one hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.