Osteopathic Treatment on Motor Development of Hypotonic Infants.

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparison of Osteopathic Treatment Versus Simulation on Motor Development of Hypotonic Infants.

Conditions
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Hypotonia

Intervention / Treatment
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* Other: ostheopathy
* Other: simulated osteopathic treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopatic treatment<br>An osteopatic treatment will be realised by osteopath | Other: ostheopathy<br>* standardized osteopathic treatment<br>|
| Placebo Comparator: simulated osteopathic treatment<br>A simulated ostepathic treatment will be realised by osteopath | Other: simulated osteopathic treatment<br>* standardized simulated osteopathic treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor development on the Denver II scale | 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 | at month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor development on the Denver II scale |  | at month 2 | 
| Motor development on the Denver II scale |  | at month 4 | 
| Satisfaction visual scale (from 0 to 10) | comparison of parents satisfaction with a visual analogic scale in the 2 groups | at month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteopathy, hypotonia, children