Osteopathic Treatment on Motor Development of Hypotonic Infants. (HYPOSTEO)

Comparison of Osteopathic Treatment Versus Simulation on Motor Development of Hypotonic Infants.

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

Study Overview

• Status: Recruiting
• Conditions: Hypotonia
• Intervention / Treatment: Other: ostheopathy; Other: simulated osteopathic treatment

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: camille JUNG, MDPhD; Phone Number: +33 157022268; Email: camille.jung@chicreteil.fr
• Study Contact Backup: Name: Roselyne LALAUZE-POL; Phone Number: +33 140540578; Email: r.lalauze@wanadoo.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • CHI Créteil
    • Contact: Coraline GRISEL
  • Paris, France, 75014
    • Recruiting
    • Centre Broussais
    • Contact: Yannick Aujard, MD PhD; Phone Number: +33 140032000; Email: yannick.aujard@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopatic treatment; An osteopatic treatment will be realised by osteopath	Other: ostheopathy; standardized osteopathic treatment
Placebo Comparator: simulated osteopathic treatment; A simulated ostepathic treatment will be realised by osteopath	Other: simulated osteopathic treatment; standardized simulated osteopathic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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)	comparison of parents satisfaction with a visual analogic scale in the 2 groups	at month 6

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Centre Broussais

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Anticipated): June 13, 2025
• Study Completion (Anticipated): January 13, 2026

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: children; hypotonia; osteopathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Muscle Hypotonia
• Other Study ID Numbers: HYPOSTEO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No