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New treatment option for Home-based Programs
Official title EMMVIES : Walking Training at Home in VIrtual Reality for Children With Chronic Illnesses Impacting Physical Health
ClinicalTrials.gov ID: NCT07021638
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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;
You likely can't join if
- 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...
- 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;
See the full eligibility 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
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.