Actively Recruiting

Phase Not Applicable
Age: 6Years - 17Years
All Genders
NCT07021638

EMMVIES : Walking Training at Home in VIrtual Reality for Children With Chronic Illnesses Impacting Physical Health

Led by University Hospital, Angers · Updated on 2025-12-31

30

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Over the past 30 years, the prevalence of congenital or acquired chronic diseases in children has risen, affecting between 10 and 30% of them, or at least 100,000 children in France. Pathologies such as cerebral palsy (CP), neuromuscular diseases (NMD), obesity or congenital heart disease impact physical health by causing musculoskeletal, respiratory or cardiovascular deficiencies. These limitations influence their ability to participate in daily activities, affecting their quality of life and that of their families.To minimize these impacts, motor rehabilitation programs focusing on physical activity are proposed, but their effectiveness requires prolonged practice. However, these specific programs, often delivered in remote specialized centers, are difficult to access. Home programs have been developed to overcome these constraints. They enable children, with the support of their parents, to carry out therapeutic activities at home. Although their feasibility has been demonstrated, their effectiveness is relative. A multitude of protocols and tools have been tested, with no harmonization of practices.To support the implementation of home-based programs for children with CP or obesity, virtual reality has already been used, mainly on the basis of commercial solutions. This solution is therefore feasible and has proved relatively effective.With this in mind, and based on the user experience of children, parents and professionals, the investigators have initially co-developed with the French company EzyGain a connected treadmill specifically adapted to pediatric needs and the requirements of home programs. The AMY treadmill is a compact treadmill with on-board sensors and a safety system, communicating with a tablet application and a virtual reality headset.Taking into account the opportunities offered by this new technology, as well as building on the effects and features already known from home programs, the investigators have developed a new modality for home programs focusing on walking for children with CP, MNM and obesity, the EMMVIES program. The crucial step now is to investigate the feasibility, tolerance and clinical effects of this EMMVIES program.

CONDITIONS

Official Title

EMMVIES : Walking Training at Home in VIrtual Reality for Children With Chronic Illnesses Impacting Physical Health

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 6 to 17 years at date of inclusion
  • Able to walk for 5 minutes on a treadmill with or without body weight support, with or without technical aids
  • Able to understand and play virtual reality games (immersive or non-immersive)
  • Able to answer questionnaires
  • Patient affiliated to or benefiting from a social security scheme
  • Informed consent signed by parents or guardians if minor
  • Included in a care program specific to their chronic condition for at least 6 months
  • For cerebral palsy group: diagnosis of CP, Gross Motor Function Classification System level II or III, rehabilitation goal to improve gait or gross motor function
  • For obesity group: overweight or obese with BMI above IOTF-25 percentile, aim to increase daily physical activity, no history of hip pathology
  • For neuromuscular group: diagnosis of spinal muscular atrophy type 3, Duchenne disease, congenital myopathy or Charcot Marie Tooth, functional level grade 2 to 6 on Walton scale or grade 3 to 7 on Vignos scale, rehabilitation goal to improve walking or gross motor skills
Not Eligible

You will not qualify if you...

  • Patients weighing over 100 kg (technical constraints of the AMY treadmill)
  • For children aged 6 to 11 using immersive virtual reality: problems with stereoscopic vision, unstabilized epilepsy, facial trauma less than 3 months old, hearing or visual impairment, pain, dizziness or nausea from virtual reality use
  • Surgery within the last 3 months
  • Intramuscular botulinum toxin injections in lower limbs or intensive therapy within 3 months prior to inclusion
  • Non-routine therapeutic program planned within 5 months that could interfere with the study
  • Insufficient understanding of French language
  • Opposition to participation by child or adolescent
  • Persons deprived of liberty by judicial or administrative decision
  • Persons under compulsory psychiatric care
  • Persons under legal protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Les Capucins

Angers, France

Actively Recruiting

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Research Team

M

Mickaël DINOMAIS, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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EMMVIES : Walking Training at Home in VIrtual Reality for Children With Chronic Illnesses Impacting Physical Health | DecenTrialz