NCT03852004

Osteopathic Treatment on Motor Development of Hypotonic Infants.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 8 Months – 24 Months
• Healthy volunteers: Not accepted

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

Conditions

• Hypotonia

Interventions

Type	Name	Description
OTHER	ostheopathy	standardized osteopathic treatment
OTHER	simulated osteopathic treatment	standardized simulated osteopathic treatment

Timeline

• Start date: 2018-12-13
• Primary completion: 2025-06-13
• Completion: 2026-01-13
• First posted: 2019-02-22
• Last updated: 2023-05-06

Locations

2 sites across 1 country: France