NCT07840872

Brief Summary

The goal of this clinical trial is to learn how wearing the Hypershell lower-limb exoskeleton affects perceived fatigue during everyday mobility activities in adults aged 65 years and older. The main questions it aims to answer are:

  • Does active assistance from the Hypershell reduce the development of perceived fatigue during repeated everyday mobility tasks?
  • Does wearing the Hypershell affect how long participants can perform the protocol and how many tasks they can complete before reaching a high level of fatigue?
  • How do participants perceive the usability, comfort, and overall experience of using the Hypershell?
  • What are the biomechanical and physiological responses from wearing the Hypershell? Researchers will compare two conditions: performing the mobility protocol without the Hypershell and wearing the Hypershell with active assistance. Participants will:
  • Attend one baseline session including questionnaires, physical tests, and familiarization with the Hypershell and study procedures.
  • Attend two experimental sessions in a randomized order, with at least one week between sessions.
  • Complete a laboratory-based mobility protocol including daily activities such as standing up from a chair, walking, stair climbing, slope walking, walking on uneven surfaces, carrying an object, and performing a cognitive task while walking.
  • Report their perceived fatigue throughout the protocol using the Borg CR10 scale.
  • Wear non-invasive sensors that measure physiological responses and movement during the experimental sessions.
  • Provide feedback about their experience using the HyperShell.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress1%
Oct 2026Jun 2027

First Submitted

Initial submission to the registry

September 10, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

8 months

First QC Date

September 10, 2026

Last Update Submit

September 18, 2026

Conditions

FatigueOlder Adults (65 Years and Older)Exoskeleton Device

Outcome Measures

Primary Outcomes (3)

  • Rate of Perceived Fatigue Progression

    Rating of Perceived Fatigue (RPF) will be assessed verbally using the Borg Category-Ratio 10 (CR10) scale after each task of the FATIG'AGE protocol. The Borg CR10 ranges from 0 (no exertion) to 10 (maximal exertion). The rate of increase in RPE across consecutive task executions will be determined for each experimental condition, with a lower rate indicating a slower development of perceived exertion.

    During each experimental session, up to 60 minutes

  • Protocol Duration Until Termination

    Total time, in minutes, that the participant performs the FATIG'AGE protocol before reaching a predefined termination criterion: Borg CR10 greater or equal to two consecutive score of 8, or the maximum protocol duration of 60 minutes. Longer duration indicates that the participant was able to perform the protocol for longer before termination.

    During each experimental session, up to 60 minutes

  • Number of Executed Tasks Until Protocol Termination

    Total number of individual FATIG'AGE task executions completed before reaching a predefined termination criterion: Borg CR10 equal or greater to two consecutive scores of 8, or the maximum protocol duration of 60 minutes. A higher number indicates that more functional mobility tasks were completed before protocol termination.

    During each experimental session, up to 60 minutes

Secondary Outcomes (9)

  • Global Perceived Effect of the Hypershell

    Immediately after each applicable experimental session

  • Usability of the HyperShell Assessed With the System Usability Scale

    Immediately after the Hypershell active-assistance experimental session

  • User Experience With the Hypershell Assessed With the User Experience Questionnaire

    Immediately after the Hypershell active-assistance experimental session

  • Lower-Limb Muscle Activity

    Continuously during each experimental session, up to 60 minutes

  • Heart Rate

    Continuously during each experimental session, up to 60 minutes.

  • +4 more secondary outcomes

Study Arms (2)

EXO-OFF → EXO-ON Actuation

EXPERIMENTAL

Participants complete the FATIG'AGE protocol under two conditions in the following order: without wearing the Hypershell and wearing the Hypershell with active assistance. Experimental sessions are separated by a washout period of at least one week.

Other: Performance testDevice: Hypershell assistance (EXO-ON Actuation)

EXO-ON Actuation → EXO-OFF

EXPERIMENTAL

Participants complete the FATIG'AGE protocol under two conditions in the following order: wearing the Hypershell with active assistance and without wearing the Hypershell. Experimental sessions are separated by a washout period of at least one week.

Other: Performance testDevice: Hypershell assistance (EXO-ON Actuation)

Interventions

Performance testOTHER

Participants will perform the FATIG'AGE multi-task functional mobility protocol. The protocol includes a fixed sequence of daily activities such as walking, sit-to-stand transitions, stair ascent and descent, slope walking, walking on uneven surfaces, carrying an object, and dual-task walking.

Also known as: FATIG'AGE protocol
EXO-OFF → EXO-ON ActuationEXO-ON Actuation → EXO-OFF
Hypershell assistance (EXO-ON Actuation)DEVICE

Participants wear the Hypershell hip exoskeleton with active assistance. In the active-assistance condition, the device uses motion sensors to detect the user's movements and provides powered assistance to support hip movement during functional mobility tasks

EXO-OFF → EXO-ON ActuationEXO-ON Actuation → EXO-OFF

Eligibility Criteria

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

You may qualify if:

  • Aged 65 years or older
  • Good mobility according to the International Classification of Functioning, Disability and Health (ICF) mobility classification

You may not qualify if:

  • Physical injury or disorder that does not allow good physical performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brubotics Rehabilitation Research Center

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eva Swinnen, Prof

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reinhard Claeys

CONTACT

02 477 44 89reinhard.claeys@vub.be

Eva Swinnen

CONTACT

eva.swinnen@vub.be

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
Professor

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 25, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

There is currently no plan to make individual participant data (IPD) available to researchers outside the study team. Study data will be securely retained for planned in-house follow-up analyses and to protect participant privacy and confidentiality in accordance with applicable data protection requirements. Aggregate study results will be disseminated through scientific publications and presentations.

Locations

BE(1)