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

Not Applicable

Completed

• Conditions: Sarcopenia; Stroke
• Interventions: Other: Focus group discussion

• Registration Number: NCT06238206
• Lead Sponsor: Vrije Universiteit Brussel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-13
• Study Start: 2024-01-17
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-02-02
• Status Verified: 2024-04
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
People post-stroke	Focus group discussion	The focus group discussion will assess the needs and requirements of this group.
Physiotherapists	Focus group discussion	The focus group discussion will assess the needs and requirements of this group.
Older adults with sarcopenia	Focus group discussion	The focus group discussion will assess the needs and requirements of this group.

Primary Outcome Measures

Name	Time	Method
User Personas	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.
Interface and Design Concept Formulation	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.
Digital Rehabilitation Outcomes	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.
Identification of Activities for Exoskeleton Use	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.

Trial Locations

Locations (1)

Brubotics Rehabilitation Research Center; 🇧🇪 Jette, Brussels, Belgium