Torticollis (Arthrogenic)NCT07855731
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
An observational study of Torticollis (Arthrogenic), run by Balgrist University Hospital.
Trial summary
Babies with torticollis (a tilted or twisted neck) have difficulty turning their head fully to the side. Small movement sensors = Inertial Measurement Units (IMUs) can be used to measure how far they can turn their head. In an earlier study, these measurements were carried out by a trained professional. Read more about this study
- Who is it for?
- Ages 3 to 8 months
- Conditions the study is for
- Torticollis (Arthrogenic)
- What is being tested?
- Mobilisation of the upper cervical spine (but the effectiveness of the investigation is not part of the study evaluation)
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2026to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 8 months
- All sexes
- No healthy volunteers
- Child
Study population: The study population includes infants aged 3 to 8 months with arthrogenic torticollis (AT) or suspected dysfunction of the upper cervical spine who have been referred for chiropractic treatment.
Who may be able to join
- Age between 3 and 8 months at the time of the measurements
- Referral for chiropractic treatment with suspected AT or suspected dysfunction of the upper cervical spine
- Written informed consent signed by the parents after they have received sufficient information about the study-
Who cannot join
- Previous surgery or injury to the cervical spine
- Other systemic health conditions, e.g. cerebral palsy
- Developmental delay of the infant
- Insufficient German language skills of the parents to understand the informed consent form and to carry out the measurements independently
- Excessive distress or resistance by the infant, such as crying, screaming, or similar reactions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Babies with torticollis (a tilted or twisted neck) have difficulty turning their head fully to the side. Small movement sensors = Inertial Measurement Units (IMUs) can be used to measure how far they can turn their head. In an earlier study, these measurements were carried out by a trained professional. We now want to find out whether parents can do the measurements themselves at home and whether this works well in everyday practice.
Read the detailed description
Your child will wear a baby hat with a small movement sensor (IMU, approximately, 10 g) and a soft chest strap with a second sensor during the first appointment (with a member of the study team). The measurements will take place at home on 5 consecutive days.
Procedure: On the first day of measurement, a member of the study team will be present. They will explain exactly how the measurements should be carried out. You will also receive written instructions (Standard Operating Procedure). On the following four days, you will carry out the measurements yourself. You will encourage your child to turn their head using a rattle. This will take approximately 7-10 minutes. If you are unsure about anything or have any questions, the study team will be available by phone or online.
Duration: Five consecutive days. On day 5, you will complete a short questionnaire about how easy the instructions were to understand, how well the movement sensors were accepted, how the measurements went, and the amount of effort involved.
Time and effort required: 1 appointment with a member of the study team at your home (approximately 30-45 minutes) + 4 measurements carried out by yourself (approximately 7-10 minutes each) and, additionally, a questionnaire on day 5 (approximately 5 minutes).
Benefits: Your child will not benefit directly from taking part in the study. In the future, the study may help to provide children with arthrogenic torticollis with a more accurate diagnosis and better monitoring of their treatment through improved measurement methods.
Risks and burden: The risk is very low (Category A). The movement sensor is attached to a baby hat and does not come into direct contact with the skin. Your child will turn their head actively, and the movement will not be forced from the outside. If your child shows any signs of discomfort or resistance, the measurement can be stopped.
- Conditions
- Torticollis (Arthrogenic)
- Being tested
- Mobilisation of the upper cervical spine (but the effectiveness of the investigation is not part of the study evaluation)
- Keywords
- Infant, Cervical range of motion, arthrogenic torticollis, feasibility, Intertial measurement unit
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilisation of the upper cervical spine (but the effectiveness of the investigation is not part of the study evaluation)Other
Mobilisation of the upper cervical spine (C1/C2).
| Study group | Role | What they receive |
|---|---|---|
| Infants with athrogenic torticollis | Infants aged 3 to 8 months with arthrogenic torticollis (AT) or suspected dysfunction of the upper cervical spine who have been referred for chiropractic treatment. The study includes infants of both biological sexes.
Inclusion criteria:
Age between 3 and 8 months at the time of the measurements Referral for chiropractic treatment with suspected AT or suspected dysfunction of the upper cervical spine Written informed consent signed by the parents after they have received sufficient information about the study
Exclusion criteria:
Previous surgery or injury to the cervical spine Other systemic health conditions, e.g. cerebral palsy Developmental delay of the infant Insufficient German language skills of the parents to understand the informed consent form and to carry out the measure Excessive distress or resistance by the infant, such as crying, screaming, or similar reactions Receives: Other: Mobilisation of the upper cervical spine (but the effectiveness of the investigation is not part of the study evaluation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Data completeness 2) Recruitment rate and dropout 3) Graph quality 4) Parent questionnaire 5) Time and logistical effort required by the study team
Data completeness: ≥80% of measurements successfully recorded, i.e. at least 4 out of 5 measurements per infant. Measured based on the number of successfully saved IMU datasets per participant.
Recruitment rate and dropout rate
Graph quality: Visual inspection by two persons based on the following criteria: initial line, continuous measurement line, unphysiological peaks, and clearly identifiable rotational movement. Target: ≥80% rated as good.
Parent questionnaire using a Likert scale: Comprehensibility of the SOP: ≥80% rated as "good/very good"; feasibility: ≥80% rated as "easy/very easy"; acceptance of the IMUs by the child: ≥80% rated as "good/very good."
Time and logistical effort required by the study team: Documented and considered feasible if no delays occur.
Measured: From enrollment to end of data collection = 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start7 Oct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Torticollis (Arthrogenic)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Schweinhardt Petra, Balgrist University Hospital
- Investigators
- Petra Schweinhardt, PhD, Study chair, Balgrist University Hospital and University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855731
- Sponsor's protocol ID
- 2026-01419
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 8 Oct 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
- ClinicalTrials.gov ID
- NCT07855731
- Acronym / sponsor ID
- 2026-01419
- Conditions
- Torticollis (Arthrogenic)
- Keywords
- Infant, Cervical range of motion, arthrogenic torticollis, feasibility, Intertial measurement unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 7 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Oct 2026 (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.
Babies with torticollis (a tilted or twisted neck) have difficulty turning their head fully to the side. Small movement sensors = Inertial Measurement Units (IMUs) can be used to measure how far they can turn their head. In an earlier study, these measurements were carried out by a trained professional. We now want to find out whether parents can do the measurements themselves at home and whether this works well in everyday practice.
Detailed description
Your child will wear a baby hat with a small movement sensor (IMU, approximately, 10 g) and a soft chest strap with a second sensor during the first appointment (with a member of the study team). The measurements will take place at home on 5 consecutive days.
Procedure: On the first day of measurement, a member of the study team will be present. They will explain exactly how the measurements should be carried out. You will also receive written instructions (Standard Operating Procedure). On the following four days, you will carry out the measurements yourself. You will encourage your child to turn their head using a rattle. This will take approximately 7-10 minutes. If you are unsure about anything or have any questions, the study team will be available by phone or online.
Duration: Five consecutive days. On day 5, you will complete a short questionnaire about how easy the instructions were to understand, how well the movement sensors were accepted, how the measurements went, and the amount of effort involved.
Time and effort required: 1 appointment with a member of the study team at your home (approximately 30-45 minutes) + 4 measurements carried out by yourself (approximately 7-10 minutes each) and, additionally, a questionnaire on day 5 (approximately 5 minutes).
Benefits: Your child will not benefit directly from taking part in the study. In the future, the study may help to provide children with arthrogenic torticollis with a more accurate diagnosis and better monitoring of their treatment through improved measurement methods.
Risks and burden: The risk is very low (Category A). The movement sensor is attached to a baby hat and does not come into direct contact with the skin. Your child will turn their head actively, and the movement will not be forced from the outside. If your child shows any signs of discomfort or resistance, the measurement can be stopped.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with athrogenic torticollis | – | Other: Mobilisation of the upper cervical spine (but the effectiveness of the investigation is not part of the study evaluation)Infants aged 3 to 8 months with arthrogenic torticollis (AT) or suspected dysfunction of the upper cervical spine who have been referred for chiropractic treatment. The study includes infants of both biological sexes. Inclusion criteria: Age between 3 and 8 months at the time of the measurements Referral for chiropractic treatment with suspected AT or suspected dysfunction of the upper cervical spine Written informed consent signed by the parents after they have received sufficient information about the study Exclusion criteria: Previous surgery or injury to the cervical spine Other systemic health conditions, e.g. cerebral palsy Developmental delay of the infant Insufficient German language skills of the parents to understand the informed consent form and to carry out the measure Excessive distress or resistance by the infant, such as crying, screaming, or similar reactions |
Who may qualify
- Ages
- 3 to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population includes infants aged 3 to 8 months with arthrogenic torticollis (AT) or suspected dysfunction of the upper cervical spine who have been referred for chiropractic treatment.
Key inclusion criteria (3 listed)
- Age between 3 and 8 months at the time of the measurements
- Referral for chiropractic treatment with suspected AT or suspected dysfunction of the upper cervical spine
- Written informed consent signed by the parents after they have received sufficient information about the study-
Key exclusion criteria (5 listed)
- Previous surgery or injury to the cervical spine
- Other systemic health conditions, e.g. cerebral palsy
- Developmental delay of the infant
- Insufficient German language skills of the parents to understand the informed consent form and to carry out the measurements independently
- Excessive distress or resistance by the infant, such as crying, screaming, or similar reactions
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 |
|---|---|---|
| Mobilisation of the upper cervical spine (but the effectiveness of the investigation is not part of the study evaluation)Mobilisation of the upper cervical spine (C1/C2). | Other | Infants with athrogenic torticollis |
Primary outcome
1) Data completeness 2) Recruitment rate and dropout 3) Graph quality 4) Parent questionnaire 5) Time and logistical effort required by the study team
Time frame: From enrollment to end of data collection = 5 days
Data completeness: ≥80% of measurements successfully recorded, i.e. at least 4 out of 5 measurements per infant. Measured based on the number of successfully saved IMU datasets per participant. Recruitment rate and dropout rate Graph quality: Visual inspection by two persons based on the following criteria: initial line, continuous measurement line, unphysiological peaks, and clearly identifiable rotational movement. Target: ≥80% rated as good. Parent questionnaire using a Likert scale: Comprehensibility of the SOP: ≥80% rated as "good/very good"; feasibility: ≥80% rated as "easy/very easy"; acceptance of the IMUs by the child: ≥80% rated as "good/very good." Time and logistical effort required by the study team: Documented and considered feasible if no delays occur.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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.
Petra Schweinhardt, PhD study chair
Balgrist University Hospital and University of Zurich
Questions about this trial
What is this clinical trial studying?
An observational study of Torticollis (Arthrogenic), run by Balgrist University Hospital.
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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anke Langenfeld, PhD (+ 41 44 386 ext. 57 30, anke.langenfeld@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) Data completeness 2) Recruitment rate and dropout 3) Graph quality 4) Parent questionnaire 5) Time and logistical effort required by the study team (time frame: From enrollment to end of data collection = 5 days). 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 8 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.