Osteopathic Treatment on Motor Development of Hypotonic I... | NCT03852004

Studies
Osteopathic Treatment on Motor Development of Hypotonic Infants.

NCT03852004

Sponsor

Centre Hospitalier Intercommunal Creteil

Status

Terminated

Last Update Posted

Jun 29, 2026Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Hypotonia

Interventions

ostheopathy
simulated osteopathic treatment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enouge inclusions

Expanded Access Info

Start Date

Dec 13, 2018Actual

Primary Completion Date

Jun 13, 2025Actual

Completion Date

Jan 13, 2026Actual

First Submitted Date

Feb 21, 2019

First Submission Date that Met QC Criteria

Feb 21, 2019

First Posted Date

Feb 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2026

Last Update Posted Date

Jun 29, 2026Actual

Name	Class
Centre Broussais	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Osteopatic treatment	Experimental	An osteopatic treatment will be realised by osteopath	Other: ostheopathy
simulated osteopathic treatment	Placebo Comparator	A simulated ostepathic treatment will be realised by osteopath	Other: simulated osteopathic treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ostheopathy	Other	standardized osteopathic treatment	Osteopatic treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Months

Maximum Age

24 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHI Creteil		Créteil		94000	France
Centre Broussais

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009123	Muscle Hypotonia

Ancestor Terms

ID	Term
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided