About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
EMMVIES program
Other interventionWalking Training at Home in VIrtual Reality for Children with Chronic Illnesses Impacting Physical Health
Treatment groups
Trial outcomes
Primary outcomes
Home rehabilitation program
The treadmill walking training program comprises a minimum of 3 sessions per week, with one day of rest between each session. Each session comprises around 30 minutes of physical exercise on a mat, alternating between walking and balance exercises.
Secondary outcomes
Assessment of lower limb muscle strength
Muscle strength is measured using a wireless electronic hand dynamometer (DEM) (MicroFET 2) based on a standardized protocol used in clinical routine and performed on an examination table on the following muscle groups: plantar flexors (knee extended and flexed), knee flexors and extensors and hip abductors. The child is asked to contract each muscle group tested for 3 to 5 seconds, three times against the dynamometer held by an assessor. The average of the three peak pressures achieved for each muscle group tested is recorded. The estimated duration of these measurements is 15 minutes.
10-meter walk test
Patients' gait quality is assessed using a minimal version of the Quantified Gait Analysis (QGA), which simply includes spatiotemporal, kinematic and electromyographic gait parameters. To this end, 10-meter barefoot walking tests at spontaneous (2 trials), fast (2 trials) and double-task speeds, i.e. walking and listing animal names (1 trial) and fruit names (1 trial), and finally with usual shoes and orthoses, are carried out. Walking tests are performed in comfortable clothing, as close to the body as possible, with uncovered legs (shorts). A walking frame is authorized for children who cannot walk 10 meters without one. The total duration of the assessment for the child is 20 minutes.
6-minute walk test
Walking endurance is assessed by the 6-minute walking test (TDM6). According to the instructions for this test, the distance covered in 6 minutes is observed. Children are asked to walk as far as possible in 6 minutes on a 60-meter marked track in corridors. Children are fitted with shoes, orthoses and/or walking aids, depending on their habits. Footwear and technical aids must be identical between the 3 evaluation times T0, T1 and T2. An indication of the remaining test time is given to the children every minute by the investigator. The duration of the test for the child is estimated at 10 minutes.
Motion control assessment
Somatosensory function is measured by the cortico-cinematic coherence (CKC) index, which reflects the correlation between electrical activity in the primary sensorimotor cortex (measured by conventional low-density electroencephalogram (EEG)) and displacement of the center of pressure (CoP) in standing static equilibrium for 2 minutes (measured by a force platform). This exploratory index will enable us to estimate the cortical processing of proprioceptive afferents in the lower limbs. The estimated duration of this measurement is 10 minutes.
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