What User-requirements Need to be Considered When Developing a Lower-limb Exoskeleton? A Qualitative Study.

April 16, 2024 updated by: Eva Swinnen, Vrije Universiteit Brussel

The goal of this study is to identify the needs and requirements of end-users regarding the implementation of a lower-limb exoskeleton in a remote home setting. The end-users include older adults with sarcopenia, post-stroke individuals and physiotherapists. The main question it aims to answer is:

• What are the needs and requirements of the end-user population when developing a lower-limb exoskeleton that can be implemented in a remote home setting?

Participants will engage in three separate focus group sessions, in which they will discuss the predetermined topics. Interactions between the participants will be guided by open questions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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

  • Belgium
    • Brussels
      • Jette, Brussels, Belgium, 1090
        • Brubotics Rehabilitation Research Center

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

People post-stroke:

Inclusion Criteria:

  • > 18 years old
  • ≥ 3 months ago stroke diagnosis
  • Current difficulties during gait

Exclusion Criteria:

  • Serious speech disorder
  • Lowered cognitive competence

Older adults with sarcopenia:

Inclusion Criteria:

  • > 65 years old
  • Difficulties during chair sit to stand
  • Current difficulties during gait

Exclusion Criteria:

  • Lowered cognitive competence

Physiotherapist:

Inclusion Criteria:

  • Currently active as a physiotherapist
  • Experience in treating people with sarcopenia and/or post-stroke conditions

Exclusion criteria:

  • Can't verbally answer

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: People post-stroke
The focus group discussion will assess the needs and requirements of this group.
Other: Focus group discussion
The participant will be asked to take part in three separate focus group discussions implementing the co-design principle. Following the co-design principle the participants will actively contribute towards the primary outcomes. Open questions will be asked to guide the discussion. Interaction between participants will be encouraged.
Experimental: Older adults with sarcopenia
The focus group discussion will assess the needs and requirements of this group.
Other: Focus group discussion
The participant will be asked to take part in three separate focus group discussions implementing the co-design principle. Following the co-design principle the participants will actively contribute towards the primary outcomes. Open questions will be asked to guide the discussion. Interaction between participants will be encouraged.
Experimental: Physiotherapists
The focus group discussion will assess the needs and requirements of this group.
Other: Focus group discussion
The participant will be asked to take part in three separate focus group discussions implementing the co-design principle. Following the co-design principle the participants will actively contribute towards the primary outcomes. Open questions will be asked to guide the discussion. Interaction between participants will be encouraged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User Personas
Time Frame: 8 weeks
A set of personas (=representation of a group of individuals with common characteristics) will be defined for both the older adults with sarcopenia and the stroke survivors. This is identified through the qualitative analysis of the answers on predefined open questions during the focus group discussion.
8 weeks
Identification of Activities for Exoskeleton Use
Time Frame: 8 weeks
Specific activities where exoskeletons demonstrate added value will be defined. This is identified through the qualitive analysis of the answers on predefined open questions during the focus group discussion.
8 weeks
Interface and Design Concept Formulation
Time Frame: 8 weeks
Key elements on the interface and design concept of exoskeletons will be described. This is identified through the qualitive analysis of the answers on predefined open questions during the focus group discussion.
8 weeks
Digital Rehabilitation Outcomes
Time Frame: 8 weeks
Key elements of rehabilitation measures that an exoskeletons should be able to assess will be described. This is identified through the qualitive analysis of the answers on predefined open questions during the focus group discussion.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vrije Universiteit Brussel

Investigators

  • Principal Investigator: Eva Swinnen, 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)

January 17, 2024

Primary Completion (Actual)

April 5, 2024

Study Completion (Actual)

April 5, 2024

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RevalEXO1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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