Osteopathic Treatment on Motor Development of Hypotonic Infants.
NCT ID: NCT03852004
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2018-12-13
2026-01-13
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Osteopatic treatment
An osteopatic treatment will be realised by osteopath
ostheopathy
standardized osteopathic treatment
simulated osteopathic treatment
A simulated ostepathic treatment will be realised by osteopath
simulated osteopathic treatment
standardized simulated osteopathic treatment
Interventions
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ostheopathy
standardized osteopathic treatment
simulated osteopathic treatment
standardized simulated osteopathic treatment
Eligibility Criteria
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Inclusion Criteria
* Proposal for osteopathic treatment by the pediatrician or treating physician
Exclusion Criteria
* Neuromuscular diseases without axial hypotonia
* Not affiliated to a social security scheme
* Refusal to participate in the study by parents
8 Months
24 Months
ALL
No
Sponsors
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Centre Broussais
UNKNOWN
Centre Hospitalier Intercommunal Creteil
OTHER
Responsible Party
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Locations
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CHI Creteil
Créteil, , France
Centre Broussais
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Coraline GRISEL
Role: primary
Other Identifiers
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HYPOSTEO
Identifier Type: -
Identifier Source: org_study_id
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