- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359573
The Effect of a Passive Hip Exoskeleton on Daily-life Fatigue in Older Adults
January 21, 2026 updated by: David Beckwee, Vrije Universiteit Brussel
Evaluating and Monitoring Physical Fatigue While Performing Functional Activities
This crossover study investigates whether a passive lower-limb exoskeleton (Exoband) can reduce perceived exertion during everyday mobility tasks in older adults.
Participants complete the fatigue protocol- a structured sequence of daily challenging tasks (e.g., overground walking, stair and slope walking, obstacle avoidance)-once with the Exoband and once without it, in randomized order and separated by a one-week washout period.
During each session, distance covered until fatigue, rate of perceived exertion, physiological and gait parameters are recorded.
The aim is to determine whether exoskeleton assistance enhances mobility performance and reduces functional fatigue across older adults.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
15
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 Locations
-
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Brussels Capital
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Jette, Brussels Capital, Belgium, 1090
- Brubotics Rehabilitation Research Center
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-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- > 65 years old
- Healthy physical condition
Exclusion Criteria:
- Physical injury or disorder that doesn't allow good physical performance
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exoband ON
The participants execute the fatigue protocol while wearing the passive hip exoskeletons (Exoband).
|
The participant will be asked to execute a protocol in the movement lab that induces progressive feelings of fatigue.
This protocol includes a sequence of relevant functional activities, such as stair walking, slope walking, crouching, walking different path shapes.
During this execution the Ratings of Perceived Exertion will be questioned, and simultaneously physiological and movement data will be collected.
The participant will wear the Exoband (Moveo), which is a lightweight, soft wearable exoskeleton designed to assist walking by providing elastic support to the hip during gait.
It uses passive elastic elements to store and release energy in sync with the user's movement, reducing muscular effort without motors or batteries.
The system is unobtrusive and aims to support mobility while preserving natural movement patterns.
|
|
Placebo Comparator: Exoband OFF
The participants execute the fatigue protocol without wearing the passive hip exoskeletons (Exoband).
|
The participant will be asked to execute a protocol in the movement lab that induces progressive feelings of fatigue.
This protocol includes a sequence of relevant functional activities, such as stair walking, slope walking, crouching, walking different path shapes.
During this execution the Ratings of Perceived Exertion will be questioned, and simultaneously physiological and movement data will be collected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the Ratings of Perceived Exertion throughout the protocol execution
Time Frame: Through study completion, an average of 1-2 weeks.
|
The subjective feelings of fatigue will be evaluated through the Ratings of Perceived Exertion, using the modified Borg Scale (score ranging from 0 'no exertion' to 10 'maximal exertion').
This will be expressed verbally by the participant throughout the execution of the protocol.
|
Through study completion, an average of 1-2 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in muscle activity (surface EMG) throughout the protocol execution
Time Frame: Through study completion, an average of 1-2 weeks.
|
Muscle activity data will be collected continuously throughout the protocol execution.
Data acquisition will occur in a synchronized manner.
|
Through study completion, an average of 1-2 weeks.
|
|
Changes in heart rate (variability) (ECG sensors) throughout the protocol execution
Time Frame: Through study completion, an average of 1-2 weeks.
|
Cardiorespiratory data (Heart rate) will be collected continuously throughout the protocol execution.
Data acquisition will occur in a synchronized manner.
|
Through study completion, an average of 1-2 weeks.
|
|
Changes in muscle oxygen saturation (Moxy Monitor) throughout the protocol execution
Time Frame: Through study completion, an average of 1-2 weeks.
|
Oxygen saturation data will be collected continuously throughout the protocol execution.
Data acquisition will occur in a synchronized manner.
|
Through study completion, an average of 1-2 weeks.
|
|
Changes in electrodermal activity (Galvanic Skin Response - finger electrodes) throughout the protocol execution
Time Frame: Through study completion, an average of 1-2 weeks.
|
Electrodermal activity data will be collected continuously throughout the protocol execution.
Data acquisition will occur in a synchronized manner.
|
Through study completion, an average of 1-2 weeks.
|
|
Changes in motion data (IMU sensors) throughout the protocol execution
Time Frame: Through study completion, an average of 1-2 weeks.
|
Inertial Measurement Unit (IMU) data will be collected continuously throughout the protocol execution.
Data acquisition will occur in a synchronized manner.
|
Through study completion, an average of 1-2 weeks.
|
|
Changes in respiratory rate (respiratory chest band) throughout the protocol execution
Time Frame: Through study completion, an average of 1-2 weeks.
|
Respiratory data will be collected continuously throughout the protocol execution.
Data acquisition will occur in a synchronized manner.
|
Through study completion, an average of 1-2 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Beckwée, PhD, Vrije Universiteit Brussel
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)
December 11, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
December 10, 2025
First Submitted That Met QC Criteria
January 21, 2026
First Posted (Actual)
January 22, 2026
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 21, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RevalExo_Exoband
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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