Osteopathic Treatment on Motor Development of Hypotonic Infants. (HYPOSTEO)

Centre Hospitalier Intercommunal Creteil

Status: Enrolling

Conditions: Hypotonia

Treatments: Other: ostheopathy; Other: simulated osteopathic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03852004

HYPOSTEO

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 8 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Osteopatic treatment

Experimental group

Description:

An osteopatic treatment will be realised by osteopath

Treatment:

Other: ostheopathy

simulated osteopathic treatment

Placebo Comparator group

Description:

A simulated ostepathic treatment will be realised by osteopath

Treatment:

Other: simulated osteopathic treatment