StrokeNCT06238206
What User-requirements Need to be Considered When Developing a Lower-limb Exoskeleton? A Qualitative Study.
A study testing Focus group discussion in people with Stroke and Sarcopenia, run by Vrije Universiteit Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Sarcopenia
- What is being tested?
- Focus group discussion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jan 2024to 5 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- ≥ 3 months ago stroke diagnosis
- Current difficulties during gait
- > 65 years old
- Difficulties during chair sit to stand
- Current difficulties during gait
- Currently active as a physiotherapist
- Experience in treating people with sarcopenia and/or post-stroke conditions
Who cannot join
- Serious speech disorder
- Lowered cognitive competence
- Older adults with sarcopenia:
- Lowered cognitive competence
- Physiotherapist:
- Can't verbally answer
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Brubotics Rehabilitation Research Center
Jette, Brussels Capital, 1090
About this 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.
- Conditions
- Stroke, Sarcopenia
- Being tested
- Focus group discussion
- Keywords
- Assistive technology, Exoskeleton, User perspective, Stroke, Sarcopenia
- Medical subject headings
- Stroke, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group discussionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| People post-stroke | Experimental | The focus group discussion will assess the needs and requirements of this group. Receives: Other: Focus group discussion |
| Older adults with sarcopenia | Experimental | The focus group discussion will assess the needs and requirements of this group. Receives: Other: Focus group discussion |
| Physiotherapists | Experimental | The focus group discussion will assess the needs and requirements of this group. Receives: Other: Focus group discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start17 Jan 2024
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Swinnen, Vrije Universiteit Brussel
- Investigators
- Eva Swinnen, PhD, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238206
- Sponsor's protocol ID
- RevalEXO1
- Status last verified
- Apr 2024
- First submitted
- 13 Dec 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What User-requirements Need to be Considered When Developing a Lower-limb Exoskeleton? A Qualitative Study.
- ClinicalTrials.gov ID
- NCT06238206
- Acronym / sponsor ID
- RevalEXO1
- Conditions
- Stroke, Sarcopenia
- Keywords
- Assistive technology, Exoskeleton, User perspective, Stroke, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| People post-stroke | Experimental | Other: Focus group discussionThe focus group discussion will assess the needs and requirements of this group. |
| Older adults with sarcopenia | Experimental | Other: Focus group discussionThe focus group discussion will assess the needs and requirements of this group. |
| Physiotherapists | Experimental | Other: Focus group discussionThe focus group discussion will assess the needs and requirements of this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- > 18 years old
- ≥ 3 months ago stroke diagnosis
- Current difficulties during gait
- > 65 years old
- Difficulties during chair sit to stand
Key exclusion criteria (6 listed)
- Serious speech disorder
- Lowered cognitive competence
- Lowered cognitive competence
- Can't verbally answer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus group discussionThe 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. | Other | Older adults with sarcopenia, People post-stroke, Physiotherapists |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Swinnen, PhD principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus group discussion in people with Stroke and Sarcopenia, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Personas (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.