User Experience of a Gait Training Treadmill for Home Rehabilitation of Children With Chronic Conditions

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-18
SponsorUniversity Hospital, Angers

About this trial

"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)."

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged between 8 and 18 years old

capable of walking during 5 minutes on a treadmill with or without walking aid, and with or without body weight support

diagnosis of one the following pathology: bilateral cerebral palsy, obesity, spinal muscular amiotrophy type 3, Duchenne, congenital myopathy, Charcot Marie Tooth

Gross Motor Function Classification System (GMFCS) I to III for the children with cerebral palsy

Disqualifiers

Deprived of liberty by judicial or administrative decision

Subject to a legal protection measure"

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Children with cerebral palsy, obesity and neuromuscular disease, parents and therapists1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Between the second and third week

Secondary outcomes

1

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.

Time frame
Day 1 and 6 months
2

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"").

Time frame
Day 1 and 6 months
3

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?""

Time frame
Day 1 and 6 months
4

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.

Time frame
Day 1 and 6 months

Other outcomes

Sponsors and contacts

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