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Can gentle touch help babies with low muscle tone reach milestones?

NCT ID NCT03852004

Symptom relief Sponsor: Centre Hospitalier Intercommunal Creteil Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study compares osteopathic treatment to a simulated (sham) treatment in infants aged 8 to 24 months who have low muscle tone (hypotonia). The goal is to see if real osteopathy improves motor development, such as sitting and crawling, better than the simulation. Forty infants will be randomly assigned to receive either real or simulated osteopathy sessions, and their progress will be measured using the Denver II developmental scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
osteopathic manipulation
What this could lead to
If effective, osteopathy could offer a gentle, drug-free way to help infants with hypotonia reach motor milestones like sitting and crawling.
What could go wrong
This is a small, early-stage study with only 40 infants. The simulated treatment may also show benefits, and results may not apply to all children with hypotonia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Dec 2018

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 24 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Muscle Hypotonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypotonia

Contacts and locations

Locations

  • CHI Creteil

    Créteil, 94000, France

  • Centre Broussais

    Paris, 75014, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.