The Effect of a Passive Hip Exoskeleton on Daily-life Fatigue in Older Adults
Evaluating and Monitoring Physical Fatigue While Performing Functional Activities
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brussels Capital
-
Jette, Brussels Capital, Belgium, 1090
- Brubotics Rehabilitation Research Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- > 65 years old
- Healthy physical condition
Exclusion Criteria:
- Physical injury or disorder that doesn't allow good physical performance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: David Beckwée, PhD, Vrije Universiteit Brussel
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- RevalExo_Exoband
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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