Osteopathic Treatment on Motor Development of Hypotonic Infants. (HYPOSTEO)
Primary Purpose
Hypotonia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ostheopathy
simulated osteopathic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hypotonia focused on measuring osteopathy, hypotonia, children
Eligibility 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
Sites / Locations
- CHI CreteilRecruiting
- Centre BroussaisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Osteopatic treatment
simulated osteopathic treatment
Arm Description
An osteopatic treatment will be realised by osteopath
A simulated ostepathic treatment will be realised by osteopath
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Motor development on the Denver II scale
Motor development on the Denver II scale
Satisfaction visual scale (from 0 to 10)
comparison of parents satisfaction with a visual analogic scale in the 2 groups
Full Information
NCT ID
NCT03852004
First Posted
February 21, 2019
Last Updated
May 3, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Centre Broussais
1. Study Identification
Unique Protocol Identification Number
NCT03852004
Brief Title
Osteopathic Treatment on Motor Development of Hypotonic Infants.
Acronym
HYPOSTEO
Official Title
Comparison of Osteopathic Treatment Versus Simulation on Motor Development of Hypotonic Infants.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
June 13, 2025 (Anticipated)
Study Completion Date
January 13, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Centre Broussais
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotonia
Keywords
osteopathy, hypotonia, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
simulated osteopathic treatment
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osteopatic treatment
Arm Type
Experimental
Arm Description
An osteopatic treatment will be realised by osteopath
Arm Title
simulated osteopathic treatment
Arm Type
Placebo Comparator
Arm Description
A simulated ostepathic treatment will be realised by osteopath
Intervention Type
Other
Intervention Name(s)
ostheopathy
Intervention Description
standardized osteopathic treatment
Intervention Type
Other
Intervention Name(s)
simulated osteopathic treatment
Intervention Description
standardized simulated osteopathic treatment
Primary Outcome Measure Information:
Title
Motor development on the Denver II scale
Description
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
Time Frame
at month 6
Secondary Outcome Measure Information:
Title
Motor development on the Denver II scale
Time Frame
at month 2
Title
Motor development on the Denver II scale
Time Frame
at month 4
Title
Satisfaction visual scale (from 0 to 10)
Description
comparison of parents satisfaction with a visual analogic scale in the 2 groups
Time Frame
at month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
camille JUNG, MDPhD
Phone
157022268
Ext
+33
Email
camille.jung@chicreteil.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Roselyne LALAUZE-POL
Phone
140540578
Ext
+33
Email
r.lalauze@wanadoo.fr
Facility Information:
Facility Name
CHI Creteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coraline GRISEL
Facility Name
Centre Broussais
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick Aujard, MD PhD
Phone
140032000
Ext
+33
Email
yannick.aujard@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Osteopathic Treatment on Motor Development of Hypotonic Infants.
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