Chronic Diseases in ChildrenEMMVIES-UXNCT06552819
User Experience of a Gait Training Treadmill for Home Rehabilitation of Children With Chronic Conditions
An observational study of Chronic Diseases in Children, run by University Hospital, Angers at 1 site in France.
Trial summary
"In the context of limited accessibility to prolonged and efficient rehabilitation programs based on physical activity, this study aims to develop a home program for children with chronic diseases affecting physical health (including cerebral palsy, obesity, and neuromuscular diseases). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Chronic Diseases in Children
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2024to May 2025
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients and parents from the active lists of medical doctors of the structures involved in the project. Therapists of the structures involved in the project.
Who may be able to join
- parent of an eligible child
- Therapist of at least one eligible child
- Able to express oneself and respond to a questionnaire in French
- Formulate their non-opposition to participate in the research
Who cannot join
- Deprived of liberty by judicial or administrative decision
- Subject to a legal protection measure"
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Angers
Angers, Maine Et Loire, 49100
Lena CARCREFF, + 33 2 41 35 50 30, lena.carcreff@chu-angers.fr
Baptiste CHUPIN, + 33 6 62 80 56 40, baptiste.chupin@chu-angers.fr
About this study
"In the context of limited accessibility to prolonged and efficient rehabilitation programs based on physical activity, this study aims to develop a home program for children with chronic diseases affecting physical health (including cerebral palsy, obesity, and neuromuscular diseases). The French company EzyGain has designed a compact treadmill equipped with sensors and a safety system, which communicates with a tablet application and a virtual reality headset to support at-home rehabilitation. This study seeks to advance the development of this solution into a prolonged and progressive training program, tailored to positively impact children's health. Future users, including children, their parents, and therapists, will be at the heart of the development process. A qualitative methodology will be employed, incorporating focus groups and a series of user experience (UX) questionnaires. The research hypothesis is that user feedbacks will enable the development of an appropriate solution that meets their specific needs and ensures high adoption rates of the device.
This study is the first step before assessing the impact of the solution in these 3 groups of children (with cerebral palsy, obesity and neuromuscular disease)."
Read the detailed description
"Visit 1: Children, accompanied by one of their parents, will test the treadmill and the associated rehabilitation games on a tablet and in immersive virtual reality in its current version, and UX questionnaires will be administered.
Visit 2: Children, parents, and therapists, in groups of 6 to 8, will participate in focus groups during which they will express their opinions regarding the solution they tested in Visit 1 and discuss areas for improvement.
(several monthsare dedicated to the developpement of the solution by the society, based on the children, parents and therapists' feedbacks)
Visit 3: Children, accompanied by one of their parents, will test the treadmill and the associated rehabilitation games on a tablet and in immersive virtual reality in its new version, and UX questionnaires will be administered."
- Conditions
- Chronic Diseases in Children
- Being tested
- No intervention
- Keywords
- User experience, home program, treadmill, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy, obesity and neuromuscular disease, parents and therapists | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focus group outputs
List of topics addressed during the focus groups by patients, parents, and therapists. The topics will include: the needs and expectations of an at-home rehabilitation tool including virtual reality, perceived barriers and facilitators, and acceptability related to certain features of the solution.
Measured: Between the second and third week
Secondary outcomes (6)
User Experience Questionnaire (UEQ-S)
UX will be evaluated using the French short version of the User Experience Questionnaire (UEQ-S). It contains 8 items grouped into two scales: pragmatic qualities (efficiency, clarity, dependability) and hedonic qualities (stimulation, novelty). The format of the items is a semantic differential (e.g., Complicated - Simple) with a 7-point Likert scale.
Measured: Day 1 and 6 months
Usability Metric for User Experience (UMUX)
Usability will be evaluated using the French version of the Usability Metric for User Experience (UMUX). The UMUX is a short 4-item questionnaire. The items are statements regarding ease of use and usefulness, with which respondents express their agreement on a 7-point Likert scale. Scores obtained from the UMUX will allow positioning the usability of the solution on the SUS interpretation scale (""worst imaginable"", ""poor"", ""acceptable"", ""good"", ""excellent"", or ""best imaginable"").
Measured: Day 1 and 6 months
Ease with technology
Ease with technology will be assessed by the following question: ""On a scale of 1 to 10, how do you rate your ease with technologies?""
Measured: Day 1 and 6 months
Cybersickness
Cybersickness will be evaluated using the Virtual Reality Sickness Questionnaire (VRSQ) which measures motion sickness-like sensations resulting from the use of virtual reality headsets. Participants rate the severity of each of the 9 VRSQ items from 0 to 3 (none, mild, moderate, severe). The total score reflects the average of the oculomotor discomfort and disorientation scores on a scale of 100. An internal questionnaire covering aspects of comfort, enjoyment, presence in the virtual environment (VE), and immersion will be used to inquire about participants' experiences with the VE and the VR headset. Participants respond on a visual analog scale from 0 to 10.
Measured: Day 1 and 6 months
Children's perception of the games
Children's perception of the games will be assessed using an internal questionnaire inspired by the Game User Experience Satisfaction Scale (GUESS). The items are statements with which respondents express their agreement on a 7-point Likert scale. The scores for the various items will be summed and will allow the company to identify the most appreciated games and the weaknesses of others.
Measured: Day 1 and 6 months
Acceptability
The acceptability from the perspective of the therapist or parent will be assessed using an internal questionnaire . The questions include their evaluations of the child's movement behavior, the level of support needed, engagement during the session, and their opinion on the use of virtual reality on a 5-point Likert scale."
Measured: Day 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diseases in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552819
- Sponsor's protocol ID
- 49RC24_0261
- Acronym
- EMMVIES-UX
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Experience of a Gait Training Treadmill for Home Rehabilitation of Children With Chronic Conditions
- ClinicalTrials.gov ID
- NCT06552819
- Acronym / sponsor ID
- EMMVIES-UX / 49RC24_0261
- Conditions
- Chronic Diseases in Children
- Keywords
- User experience, home program, treadmill, virtual reality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Sep 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 14 Aug 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.
"In the context of limited accessibility to prolonged and efficient rehabilitation programs based on physical activity, this study aims to develop a home program for children with chronic diseases affecting physical health (including cerebral palsy, obesity, and neuromuscular diseases). The French company EzyGain has designed a compact treadmill equipped with sensors and a safety system, which communicates with a tablet application and a virtual reality headset to support at-home rehabilitation. This study seeks to advance the development of this solution into a prolonged and progressive training program, tailored to positively impact children's health. Future users, including children, their parents, and therapists, will be at the heart of the development process. A qualitative methodology will be employed, incorporating focus groups and a series of user experience (UX) questionnaires. The research hypothesis is that user feedbacks will enable the development of an appropriate solution that meets their specific needs and ensures high adoption rates of the device.
This study is the first step before assessing the impact of the solution in these 3 groups of children (with cerebral palsy, obesity and neuromuscular disease)."
Detailed description
"Visit 1: Children, accompanied by one of their parents, will test the treadmill and the associated rehabilitation games on a tablet and in immersive virtual reality in its current version, and UX questionnaires will be administered.
Visit 2: Children, parents, and therapists, in groups of 6 to 8, will participate in focus groups during which they will express their opinions regarding the solution they tested in Visit 1 and discuss areas for improvement.
(several monthsare dedicated to the developpement of the solution by the society, based on the children, parents and therapists' feedbacks)
Visit 3: Children, accompanied by one of their parents, will test the treadmill and the associated rehabilitation games on a tablet and in immersive virtual reality in its new version, and UX questionnaires will be administered."
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy, obesity and neuromuscular disease, parents and therapists | – | Other: No intervention |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients and parents from the active lists of medical doctors of the structures involved in the project. Therapists of the structures involved in the project.
Key inclusion criteria (4 listed)
- parent of an eligible child
- Therapist of at least one eligible child
- Able to express oneself and respond to a questionnaire in French
- Formulate their non-opposition to participate in the research
Key exclusion criteria (2 listed)
- Deprived of liberty by judicial or administrative decision
- Subject to a legal protection measure"
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 |
|---|---|---|
| No interventionNo intervention | Other | Children with cerebral palsy, obesity and neuromuscular disease, parents and therapists |
Primary outcome
Focus group outputs
Time frame: Between the second and third week
List of topics addressed during the focus groups by patients, parents, and therapists. The topics will include: the needs and expectations of an at-home rehabilitation tool including virtual reality, perceived barriers and facilitators, and acceptability related to certain features of the solution.
6 secondary outcomes
User Experience Questionnaire (UEQ-S)
Time frame: Day 1 and 6 months
Usability Metric for User Experience (UMUX)
Time frame: Day 1 and 6 months
Ease with technology
Time frame: Day 1 and 6 months
Cybersickness
Time frame: Day 1 and 6 months
Children's perception of the games
Time frame: Day 1 and 6 months
Acceptability
Time frame: Day 1 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Diseases in Children, run by University Hospital, Angers at 1 site in France.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Aug 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lena CARCREFF (+ 33 2 41 35 50 30, lena.carcreff@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focus group outputs (time frame: Between the second and third week). 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 14 Aug 2024.