NCT06921031

Brief Summary

The main aim of this study is to investigate the preferences of individual stroke patients for key features of an exoskeleton, intended for lower limb rehabilitation, with a view to its potential integration into the design of future exoskeletons. This will be a multicenter study. Patients will be presented different scenarios of choices about the attributes about gait exoskeleton. Conditional logistic regression models will be used to define the preferences of the subjects.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
active not 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 Start

First participant enrolled

January 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 10, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

March 17, 2025

Last Update Submit

April 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Choices of the participants

    The study will describe the distribution of participants' choices among the scenarios presented in the experiment.

    One hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic stroke patients without any specific characteristics

You may qualify if:

  • years of age or older
  • informed consent to participate in the study
  • motor impairment secondary to stroke
  • ability to answer the questionnaire with or without assistance from a relative or interviewer

You may not qualify if:

  • \- history of lower-limb exoskeleton use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chu Brest

Brest, 29609, France

Location

Centre de rééducation Kerpape

Ploemeur, 56270, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2025

First Posted

April 10, 2025

Study Start

January 15, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations