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

NCT06238206 | Completed

• 1 other identifier: RevalEXO1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Sarcopenia

Keywords

Assistive technology; Exoskeleton; User perspective; Stroke; Sarcopenia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

People post-stroke

EXPERIMENTAL

The focus group discussion will assess the needs and requirements of this group.

Other: Focus group discussion

Older adults with sarcopenia

EXPERIMENTAL

The focus group discussion will assess the needs and requirements of this group.

Other: Focus group discussion

Physiotherapists

EXPERIMENTAL

The focus group discussion will assess the needs and requirements of this group.

Other: Focus group discussion

Interventions

Focus group discussion OTHER

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.

Older adults with sarcopenia; People post-stroke; Physiotherapists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Serious speech disorder
• Lowered cognitive competence
• Older adults with sarcopenia:
• \> 65 years old
• Difficulties during chair sit to stand
• Current difficulties during gait
• Lowered cognitive competence
• Physiotherapist:
• Currently active as a physiotherapist
• Experience in treating people with sarcopenia and/or post-stroke conditions
• Can't verbally answer

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Brubotics Rehabilitation Research Center

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Stroke; Sarcopenia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Eva Swinnen, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: February 2, 2024
• Study Start: January 17, 2024
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

BE (1)