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OpenTrials
Completed

NCT Number: NCT06238206

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brubotics Rehabilitation Research Center

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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