Hypotonia
Conditions
Keywords
osteopathy, hypotonia, children
Brief summary
Interventional study involving the human at risk and minimal constraint (RIPH2), randomized single-blind comparing the impact of osteopathic treatment on the axial tone of the hypotonic infant versus simulation
Detailed description
Children referred to the "Center Broussais" clinic for hypotonia are evaluated in terms of psychomotor development by a pediatrician competent in neuro-pediatrics. It is a cabinet for the care of children from 0 to 16 years. Osteopaths and pediatricians work together in this office of which 50% are children with neurological disorders. If osteopathic care is indicated, and for children with inclusion / non-inclusion criteria, the study will be offered to parents. In case of parental acceptance, children will be randomized in single blind to receive either an osteopathic treatment (osteo group) or a simulation (simulation group). Neither the parents nor the pediatrician will know the randomization group. The osteopathic treatment or simulation will be performed in a standardized way according to a previously established protocol. In both groups, a neurological evaluation of the axial tone will be performed by a pediatrician before randomization, at the end of the first consultation and at the end of the 3rd consultation, ie 3 consultations by a pediatrician. If the child was drawn in the "simulation" group, three additional consultations will be offered at the end of the study to allow him to benefit from optimal osteopathic care
Interventions
OTHERostheopathy
standardized osteopathic treatment
OTHERsimulated osteopathic treatment
standardized simulated osteopathic treatment
Sponsors
Centre Hospitalier Intercommunal Creteil
Centre Broussais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
simulated osteopathic treatment
Eligibility
Sex/Gender
ALL
Age
8 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
Age: 8 months-24 months corrected age Axial hypotonia in the neurological examination * Age (age corrected for prematurity) of motor development evaluated on the Denver II scale below chronological age * Proposal for osteopathic treatment by the pediatrician or treating physician
Exclusion criteria
* • Fever, shock or recent fall (face, skull, spine) not medically investigated, persistent cyanosis, bulging or depressed fontanel, cervical stiffness, fever * Neuromuscular diseases without axial hypotonia * Not affiliated to a social security scheme * Refusal to participate in the study by parents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor development on the Denver II scale | at month 6 | Comparison of the difference between chronological age (in corrected age) and motor development age on the Denver II motor scale in the 2 groups after 3 osteopathy consultations or simulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor development on the Denver II scale | at month 2 | — |
| Satisfaction visual scale (from 0 to 10) | at month 6 | comparison of parents satisfaction with a visual analogic scale in the 2 groups |
Countries
France
Outcome results
None listed