User Experience of a Gait Training Treadmill for Home Rehabilitation of Children With Chronic Conditions
NCT Number: NCT06552819
Acronym: EMMVIES-UX
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Diseases in Children
Interventions: OTHER: No intervention
Sponsor: University Hospital, Angers
Sex: ALL
Age: CHILD, ADULT
Enrollment: 75
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-05
Locations: CHU Angers, Angers, Maine Et Loire, 49100, France

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). 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)."

Primary Outcome Measures: 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., Between the second and third week
Secondary Outcome Measures: 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., 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"")., 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?"", 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., 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., 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.", Day 1 and 6 months