Osteopathic Treatment on Motor Development of Hypotonic Infants.

Not Applicable

Recruiting

• Conditions: Hypotonia
• Interventions: Other: simulated osteopathic treatment; Other: ostheopathy

• Registration Number: NCT03852004
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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

Study Timeline

• Study Start: 2018-12-13
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-22
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-06-13
• Study Completion: 2026-01-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
simulated osteopathic treatment	simulated osteopathic treatment	A simulated ostepathic treatment will be realised by osteopath
Osteopatic treatment	ostheopathy	An osteopatic treatment will be realised by osteopath

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Motor development on the Denver II scale	at month 4
Satisfaction visual scale (from 0 to 10)	at month 6	comparison of parents satisfaction with a visual analogic scale in the 2 groups

Trial Locations

Locations (2)

CHI Creteil; 🇫🇷 Créteil, France

Centre Broussais; 🇫🇷 Paris, France