Clinical trial NCT03852004: Osteopathic Treatment on Motor Development of Hypotonic Infants.
Official title: Comparison of Osteopathic Treatment Versus Simulation on Motor Development of Hypotonic Infants.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypotonia
Keywords: osteopathy
hypotonia
children
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Centre Broussais
First posted: 2019-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Motor development on the Denver II scale
timeFrame: at month 6
Secondary outcomes:
measure: Motor development on the Denver II scale
timeFrame: at month 2
measure: Motor development on the Denver II scale
timeFrame: at month 4
measure: Satisfaction visual scale (from 0 to 10)
timeFrame: at month 6
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Creteil
city: Paris
country: France
facility: Centre Broussais
Study officials:
References: