NCT07359573

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Dec 2025Jun 2026

First Submitted

Initial submission to the registry

December 10, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 10, 2025

Last Update Submit

January 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in the Ratings of Perceived Exertion throughout the protocol execution

    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 Outcomes (6)

  • Changes in muscle activity (surface EMG) throughout the protocol execution

    Through study completion, an average of 1-2 weeks.

  • Changes in heart rate (variability) (ECG sensors) throughout the protocol execution

    Through study completion, an average of 1-2 weeks.

  • Changes in muscle oxygen saturation (Moxy Monitor) throughout the protocol execution

    Through study completion, an average of 1-2 weeks.

  • Changes in electrodermal activity (Galvanic Skin Response - finger electrodes) throughout the protocol execution

    Through study completion, an average of 1-2 weeks.

  • Changes in motion data (IMU sensors) throughout the protocol execution

    Through study completion, an average of 1-2 weeks.

  • +1 more secondary outcomes

Study Arms (2)

Exoband ON

ACTIVE COMPARATOR

The participants execute the fatigue protocol while wearing the passive hip exoskeletons (Exoband).

Other: Performance testDevice: Exoband

Exoband OFF

PLACEBO COMPARATOR

The participants execute the fatigue protocol without wearing the passive hip exoskeletons (Exoband).

Other: Performance test

Interventions

ExobandDEVICE

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.

Exoband ON

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.

Exoband OFFExoband ON

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • \> 65 years old
  • Healthy physical condition

You may not qualify if:

  • Physical injury or disorder that doesn't allow good physical performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brubotics Rehabilitation Research Center

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Beckwée, PhD

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 10, 2025

First Posted

January 22, 2026

Study Start

December 11, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations