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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06238206
• Other study ID #: RevalEXO1
• Status: Completed
• Phase: N/A
• Start date: January 17, 2024
• Est. completion date: April 5, 2024

Study information

• Verified date: April 2024
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 5, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Belgium	Brubotics Rehabilitation Research Center	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User Personas	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
Primary	Identification of Activities for Exoskeleton Use	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
Primary	Interface and Design Concept Formulation	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
Primary	Digital Rehabilitation Outcomes	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