Arthrogenic TorticollisCROMinfantsNCT04981782
Passive Cervical Range of Motion in Infants
An observational study of Arthrogenic Torticollis, run by Balgrist University Hospital at 2 sites in Switzerland.
Trial summary
Infants with and without torticollis will be measured at different time points to assess their passive cervical spine range of motion (pCROM). Read more about this study
- Who is it for?
- Ages 2 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Arthrogenic Torticollis
- What is being tested?
- No study specific intervention, regular care.
- How many people
- 74 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Nov 2021to 1 Aug 2024
- Phase
- Observational
- 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 2 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants with torticollis
Who may be able to join
- age 2-12 month
- signed informed consent
- diagnosed with torticollis
Who cannot join
- defense reaction e.g. crying, screaming
- other illnesses
- neck trauma
- neck surgery
- developmental delay
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Balgrist University Hospital
Zurich, 8008
About this study
Official title: Passive Cervical Range of Motion in Infants With and Without Torticollis, Before, During and After Chiropractic Treatment
Infants with and without torticollis will be measured at different time points to assess their passive cervical spine range of motion (pCROM).
Read the detailed description
Infants at the age of 2 to 12 month will be measured at several time points to assess their passive cervical range of motion. One group will include healthy subjects, the other group infants with a diagnosed torticollis. Healthy subjects will be measured at the age of 3, 4, 6 and 9 months. Infants diagnosed with torticollis, at their visit at a Chiropractor and one week later.
- Conditions
- Arthrogenic Torticollis
- Being tested
- No study specific intervention, regular care.
- Keywords
- arthrogenic Torticollis, cervical range of motion, infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study specific intervention, regular care.Other
Also called chiropractic treatment
Chiropractic care (regular care)
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | No intervention
Infants will be measured at different time points. At the age of 3,4,6 and 9 months. Receives: Other: No study specific intervention, regular care. | |
| torticollis group | No intervention
Infants will be measured at their visit to a Chiropractor. Before and after treatment. Receives: Other: No study specific intervention, regular care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
passive cervical range of motion (pCROM)
The ability of passive movement of the cervical spine will be assessed
Measured: baseline
passive cervical range of motion (pCROM)
The ability of passive movement of the cervical spine will be assessed
Measured: three months
passive cervical range of motion (pCROM)
The ability of passive movement of the cervical spine will be assessed
Measured: six months
passive cervical range of motion (pCROM)
The ability of passive movement of the cervical spine will be assessed
Measured: four months
passive cervical range of motion (pCROM)
The ability of passive movement of the cervical spine will be assessed
Measured: nine months
Secondary outcomes (2)
Demographic data child
specific data of the child is gathered
Measured: baseline
Demographic data mother
specific data of the mother is collected
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Nov 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthrogenic TorticollisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra Schweinhardt, PhD, Study chair, University of Zurich and Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981782
- Sponsor's protocol ID
- 2020-02328
- Acronym
- CROMinfants
- Status last verified
- Aug 2024
- First submitted
- 20 Jul 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peter J, Csato M, Paravicini I, Wehrli M, Schweinhardt P, Langenfeld A. Correlation of examiner judgement and radiological digital pictures in infants with upper cervical spine dysfunction: a cross-sectional study. Pediatr Radiol. 2026 Jul 11. doi: 10.1007/s00247-026-06718-8. Online ahead of print.
PubMed 42435062Langenfeld A, Paravicini I, Hobaek Siegenthaler M, Wehrli M, Hausler M, Bergander T, Schweinhardt P. Subjective and Objective Assessment of the Preferred Rotational Cervical Spine Position in Infants with an Upper Cervical Spine Dysfunction: A Cross-Sectional Study. Children (Basel). 2024 Dec 13;11(12):1515. doi: 10.3390/children11121515.
PubMed 39767944
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Cervical Range of Motion in Infants With and Without Torticollis, Before, During and After Chiropractic Treatment
- ClinicalTrials.gov ID
- NCT04981782
- Acronym / sponsor ID
- CROMinfants / 2020-02328
- Conditions
- Arthrogenic Torticollis
- Keywords
- arthrogenic Torticollis, cervical range of motion, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 29 Jul 2021 (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.
Infants with and without torticollis will be measured at different time points to assess their passive cervical spine range of motion (pCROM).
Detailed description
Infants at the age of 2 to 12 month will be measured at several time points to assess their passive cervical range of motion. One group will include healthy subjects, the other group infants with a diagnosed torticollis. Healthy subjects will be measured at the age of 3, 4, 6 and 9 months. Infants diagnosed with torticollis, at their visit at a Chiropractor and one week later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | – | Other: No study specific intervention, regular care.No intervention Infants will be measured at different time points. At the age of 3,4,6 and 9 months. |
| torticollis group | – | Other: No study specific intervention, regular care.No intervention Infants will be measured at their visit to a Chiropractor. Before and after treatment. |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants with torticollis
Key inclusion criteria (3 listed)
- age 2-12 month
- signed informed consent
- diagnosed with torticollis
Key exclusion criteria (5 listed)
- defense reaction e.g. crying, screaming
- other illnesses
- neck trauma
- neck surgery
- developmental delay
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 |
|---|---|---|
| No study specific intervention, regular care.Also: chiropractic treatmentChiropractic care (regular care) | Other | healthy subjects, torticollis group |
Primary outcome
passive cervical range of motion (pCROM)
Time frame: baseline
The ability of passive movement of the cervical spine will be assessed
passive cervical range of motion (pCROM)
Time frame: three months
The ability of passive movement of the cervical spine will be assessed
passive cervical range of motion (pCROM)
Time frame: six months
The ability of passive movement of the cervical spine will be assessed
passive cervical range of motion (pCROM)
Time frame: four months
The ability of passive movement of the cervical spine will be assessed
passive cervical range of motion (pCROM)
Time frame: nine months
The ability of passive movement of the cervical spine will be assessed
2 secondary outcomes
Demographic data child
Time frame: baseline
Demographic data mother
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 42435062Peter J, Csato M, Paravicini I, Wehrli M, Schweinhardt P, Langenfeld A. Correlation of examiner judgement and radiological digital pictures in infants with upper cervical spine dysfunction: a cross-sectional study. Pediatr Radiol. 2026 Jul 11. doi: 10.1007/s00247-026-06718-8. Online ahead of print.
- Derived from this study: PubMed 39767944Langenfeld A, Paravicini I, Hobaek Siegenthaler M, Wehrli M, Hausler M, Bergander T, Schweinhardt P. Subjective and Objective Assessment of the Preferred Rotational Cervical Spine Position in Infants with an Upper Cervical Spine Dysfunction: A Cross-Sectional Study. Children (Basel). 2024 Dec 13;11(12):1515. doi: 10.3390/children11121515.
- Individual participant dataSharing planned: No
Related trials for Arthrogenic Torticollis
Not yet recruitingObservational study
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
Torticollis (Arthrogenic)
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.
Petra Schweinhardt, PhD study chair
University of Zurich and Balgrist University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthrogenic Torticollis, run by Balgrist University Hospital at 2 sites in Switzerland.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 Aug 2024. 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 Switzerland. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
passive cervical range of motion (pCROM) (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981782, which also lists 2 linked publications.
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 22 Aug 2024.