Clinical trial NCT07021638: EMMVIES : Walking Training at Home in VIrtual Reality for Children With Chronic Illnesses Impacting Physical Health
Official title: EMMVIES : Walking Training at Home in VIrtual Reality for Children With Chronic Illnesses Impacting Physical Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Home-based Programs
EzyGain
AMY Treadmill
Cerebral Palsy
Neuromuscular Diseases (NMD)
Obesity
Virtual Reality
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2025-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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;
* Be able to understand and play virtual reality games (immersive or non-immersive);
* Be able to answer questionnaires;
* Patient affiliated to or benefiting from a social security scheme;
* Informed consent, dated and signed by parents or guardians (if minors), to participate in the study;
* Included in a care program specific to their chronic condition for at least 6 months;
* Meet the following criteria depending on the group:

PC group:

* Diagnosis of CP
* Functional level classified II or III according to the Gross Motor Function Classification System (GMFCS)
* Rehabilitation goal: improvement of gait and/or gross motor function

OB group:

* Overweight or obese, defined by a BMI above the IOTF-25 percentile
* Aim to increase daily physical activity
* No history of hip pathology

Group NM:

* Diagnosis of one of the following neuromuscular pathologies: spinal muscular atrophy type 3, Duchenne disease, congenital myopathy or Charcot Marie Tooth.
* Functional level of grade 2 to 6 on the Walton scale, or grade 3 to 7 on the Vignos scale
* Rehabilitation goal: improvement of walking and/or gross motor skills

Exclusion Criteria:

* Patients weighing over 100 kg (due to the technical constraints of using the AMY mat).
* For children aged 6 to 11: in connection with the immersive virtual reality device: problems with stereoscopic vision (perception of images in 3 dimensions), unstabilized epilepsy, facial trauma \< 3 months, hearing or visual impairment, pain, dizziness or nausea caused by using immersive virtual reality.
* Patients who have undergone surgery in the last 3 months;
* Patients who have received intramuscular botulinum toxin injections in the lower limbs or intensive therapy in the 3 months prior to inclusion;
* Patient with a non-routine therapeutic program planned within 5 months that could lead to confusion with the tested program;
* Patient with insufficient understanding of the French language;
* Patient opposition (child or adolescent);
* Persons deprived of liberty by judicial or administrative decision;
* Persons under compulsory psychiatric care;
* Persons under legal protection;

Primary outcomes:
measure: Home rehabilitation program
timeFrame: 3 x 30-minute sessions over 10 weeks
Secondary outcomes:
measure: Assessment of lower limb muscle strength
timeFrame: Inclusion, 10 weeks and 20 weeks
measure: 10-meter walk test
timeFrame: Inclusion, 10 weeks and 20 weeks
measure: 6-minute walk test
timeFrame: Inclusion, 10 weeks and 20 weeks
measure: Motion control assessment
timeFrame: Inclusion, 10 weeks and 20 weeks
measure: Balance assessment
timeFrame: Inclusion, 10 weeks and 20 weeks
measure: Assessment of gross motor functions for children with CP
timeFrame: Inclusion, 10 weeks and 20 weeks
measure: Assessment of gross motor functions for children with MNM
timeFrame: Inclusion, 10 weeks and 20 weeks
measure: Quality of life assessment
timeFrame: Inclusion, 10 weeks and 20 weeks
measure: Assessment of daily activities and mobility
timeFrame: Inclusion, 10 weeks and 20 weeks
measure: Actimetry
timeFrame: Inclusion, 10 weeks and 20 weeks
measure: User experience - User Experience Questionnaire
timeFrame: once at 20 weeks
measure: User experience - Usability Metric for User Experience
timeFrame: once at 20 weeks
measure: User experience - Mobile Applications Rating Scale version utilisateur
timeFrame: once at 20 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University hospital
Study officials:
References: