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Not yet recruiting NCT06552819

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

Observational Chronic Diseases in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Chronic Diseases in Children. Basic parameters: 8 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

"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."

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • Focus group outputs [Time frame: Between the second and third week]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

"Inclusion Criteria for the children:

  • 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
  • IMC superior to the centile IOTF-30 for the children with obesity
  • Functionnal level of 2 to 6 on the Walton scale, or 3 to 7 on the Vignos scale for the children with neuromuscular disease

Inclusion Criteria for the parents:

\- parent of an eligible child

Inclusion Criteria for the therapists:

\- Therapist of at least one eligible child

Inclusion Criteria for all:

  • Able to express oneself and respond to a questionnaire in French
  • Formulate their non-opposition to participate in the research

Exclusion criteria

  • Deprived of liberty by judicial or administrative decision
  • Subject to a legal protection measure"

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU Angers — Angers

Identifiers

NCT: NCT06552819 · 49RC24_0261

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗