Osteopathic treatment for infants with low muscle tone
Comparison of Osteopathic Treatment Versus Simulation on Motor Development of Hypotonic Infants.
This study tests if osteopathic treatment can help improve muscle tone and motor skills in infants aged 8 to 24 months who have low muscle tone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 8 Months to 24 Months |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 2 sites (Créteil and 1 other locations) |
| Trial ID | NCT03852004 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the effects of osteopathic treatment on the axial tone of hypotonic infants aged 8 to 24 months. Children referred to the 'Center Broussais' clinic for hypotonia will be assessed by a pediatrician and randomized into either an osteopathy group or a simulation group. The study involves three consultations where a neurological evaluation will be conducted to measure changes in motor development. If a child is in the simulation group, they will receive osteopathic treatment after the study concludes.
Who should consider this trial
Good fit: Ideal candidates are infants aged 8 to 24 months with axial hypotonia as determined by a pediatric neurological examination.
Not a fit: Patients with neuromuscular diseases that do not present with axial hypotonia or those with acute medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve motor development outcomes for hypotonic infants through targeted osteopathic interventions.
How similar studies have performed: While there is limited data on the effectiveness of osteopathy for hypotonia, similar studies in pediatric care have shown promising results with osteopathic interventions.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Créteil and 1 other locations
- CHI Creteil — Créteil, France (Recruiting)
- Centre Broussais — Paris, France (Recruiting)
Study contacts
- Study coordinator: camille JUNG, MDPhD
- Email: camille.jung@chicreteil.fr
- Phone: 157022268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.