Recruiting

Exoskeleton

Sponsor:

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

Code:

NCT07567482

Conditions

Parkinson's Disease (PD)

Healthy Aging

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Exoskeleton

Study Details

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

Study ID

NCT07567482

Start date

Apr 30, 2026

Status verified date

May, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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 Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Changes in Timed Up and Go (TUG) duration [ Time Frame: 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 ]
  • Changes in 5 repetitions sit-to-stand test (5STS) duration [ Time Frame: Through intervention completion, on average one hour ]

Central Contacts and Locations

Central contacts

Alexandra Potvin-Desrochers, PhD

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

Lucas Michaud, PhD

819-966-620007.labotechsoins@ssss.gouv.qc.ca

Locations

TechCare Research Lab - CISSS de l'Outaouais

Recruiting

Gatineau, Quebec, Canada, J9H 3Z1

Contacts

Alexandra Potvin-Desrochers, PhD

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

Lucas Michaud, PhD

819-966-620007.labotechsoins@ssss.gouv.qc.ca

Principal Investigator:

Alexandra Potvin-Desrochers, PhD

More Information

Sponsor

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

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre intégré de santé et de services sociaux de l'Outaouais on 2026-05-13.