Osteopathic Treatment on Motor Development of Hypotonic Infants.
HYPOSTEO
Comparison of Osteopathic Treatment Versus Simulation on Motor Development of Hypotonic Infants.
1 other identifier
interventional
40
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2018
CompletedFirst Submitted
Initial submission to the registry
February 21, 2019
CompletedFirst Posted
Study publicly available on registry
February 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2026
CompletedMay 6, 2023
May 1, 2023
6.5 years
February 21, 2019
May 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Motor development on the Denver II scale
at month 2
Motor development on the Denver II scale
at month 4
Satisfaction visual scale (from 0 to 10)
at month 6
Study Arms (2)
Osteopatic treatment
EXPERIMENTALAn osteopatic treatment will be realised by osteopath
simulated osteopathic treatment
PLACEBO COMPARATORA simulated ostepathic treatment will be realised by osteopath
Interventions
standardized simulated osteopathic treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Intercommunal Creteillead
- Centre Broussaiscollaborator
Study Sites (2)
CHI Creteil
Créteil, 94000, France
Centre Broussais
Paris, 75014, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- simulated osteopathic treatment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2019
First Posted
February 22, 2019
Study Start
December 13, 2018
Primary Completion
June 13, 2025
Study Completion
January 13, 2026
Last Updated
May 6, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share