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

NCT07567482 | Not Yet Recruiting

• 1 other identifier: 2026-266
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease (PD); Healthy Aging

Keywords

Exoskeleton; Mobility; Rehabilitation; Parkinson's Disease; Walking; Balance; Risk of falls

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Through intervention completion, on average one hour

Secondary Outcomes (3)

• Changes in gait variability

  Through intervention completion, on average one hour

• Exoskeleton acceptability (qualitative data, before exoskeleton use)

  Baseline

• Changes in exoskeleton acceptability (qualitative data, post exoskeleton use compared to pre)

  Immediately after the intervention

Study Arms (1)

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.

Device: Exoskeleton

Interventions

Exoskeleton DEVICE

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.

Conditions

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Ability to walk for at least 30 minutes with or without minimal aid
• Age ≥ 65 years old
• 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

Sponsors & Collaborators

• Centre intégré de santé et de services sociaux de l'Outaouais: lead

Study Sites (1)

TechCare Research Lab - CISSS de l'Outaouais

Gatineau, Quebec, J9H 3Z1, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Alexandra Potvin-Desrochers, PhD

CONTACT

819-966-6200; alexandra.potvin-desrochers@ssss.gouv.qc.ca

Lucas Michaud, PhD

CONTACT

819-966-6200; 07.labotechsoins@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are blinded to the level of assistance provided by the exoskeleton (i.e., blinded to conditions 2, 3, 4 and 5)
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 5, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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).
• 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.

Locations

CA (1)