HypotoniaHYPOSTEONCT03852004
Osteopathic Treatment on Motor Development of Hypotonic Infants.
A study testing ostheopathy and simulated osteopathic treatment in people with Hypotonia, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 8 to 24 months
- Conditions the study is for
- Hypotonia
- What is being tested?
- ostheopathy and simulated osteopathic treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Dec 2018to 13 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- • 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Hypotonia
- Being tested
- ostheopathy, simulated osteopathic treatment
- Keywords
- osteopathy, hypotonia, children
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ostheopathyOther
standardized osteopathic treatment
simulated osteopathic treatmentOther
standardized simulated osteopathic treatment
| Study group | Role | What they receive |
|---|---|---|
| Osteopatic treatment | Experimental | An osteopatic treatment will be realised by osteopath Receives: Other: ostheopathy |
| simulated osteopathic treatment | Placebo comparator | A simulated ostepathic treatment will be realised by osteopath Receives: Other: simulated osteopathic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at month 6
Secondary outcomes (3)
Motor development on the Denver II scale
Measured: at month 2
Motor development on the Denver II scale
Measured: at month 4
Satisfaction visual scale (from 0 to 10)
comparison of parents satisfaction with a visual analogic scale in the 2 groups
Measured: at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start13 Dec 2018
- Primary completion13 Jun 2025
- Study completion13 Jan 2026
Why it stopped: Not enouge inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Broussais
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852004
- Sponsor's protocol ID
- HYPOSTEO
- Acronym
- HYPOSTEO
- Status last verified
- Jun 2026
- First submitted
- 21 Feb 2019
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Osteopathic Treatment Versus Simulation on Motor Development of Hypotonic Infants.
- ClinicalTrials.gov ID
- NCT03852004
- Acronym / sponsor ID
- HYPOSTEO / HYPOSTEO
- Conditions
- Hypotonia
- Keywords
- osteopathy, hypotonia, children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enouge inclusions
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Centre Broussais
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopatic treatment | Experimental | Other: ostheopathyAn osteopatic treatment will be realised by osteopath |
| simulated osteopathic treatment | Placebo comparator | Other: simulated osteopathic treatmentA simulated ostepathic treatment will be realised by osteopath |
Who may qualify
- Ages
- 8 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- • Fever, shock or recent fall (face, skull, spine) not medically investigated, persistent cyanosis, bulging or depressed fontanel, cervical stiffness, fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ostheopathystandardized osteopathic treatment | Other | Osteopatic treatment |
| simulated osteopathic treatmentstandardized simulated osteopathic treatment | Other | simulated osteopathic treatment |
Primary outcome
Motor development on the Denver II scale
Time frame: at month 6
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
3 secondary outcomes
Motor development on the Denver II scale
Time frame: at month 2
Motor development on the Denver II scale
Time frame: at month 4
Satisfaction visual scale (from 0 to 10)
Time frame: at month 6
Results and safety
The study was stopped early (reason given: Not enouge inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ostheopathy and simulated osteopathic treatment in people with Hypotonia, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enouge inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor development on the Denver II scale (time frame: at month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.