Osteopathic Treatment on Motor Development of Hypotonic Infants.

Hypotonia Clinical Trial

— HYPOSTEO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03852004
• Other study ID #: HYPOSTEO
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2018
• Est. completion date: January 13, 2026

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: camille JUNG, MDPhD
• Phone: 157022268
• Email: camille.jung[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 13, 2026
• Est. primary completion date: June 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Hypotonia
• Muscle Hypotonia

Intervention

Other:
• ostheopathy
standardized osteopathic treatment
• simulated osteopathic treatment
standardized simulated osteopathic treatment

Locations

Country	Name	City	State
France	CHI Creteil	Créteil
France	Centre Broussais	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Centre Broussais

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Motor development on the Denver II scale		at month 2
Secondary	Motor development on the Denver II scale		at month 4
Secondary	Satisfaction visual scale (from 0 to 10)	comparison of parents satisfaction with a visual analogic scale in the 2 groups	at month 6