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Not yet recruitingNCT07855731Updated Oct 8, 2026

Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study

An observational study in Torticollis (Arthrogenic), sponsored by Balgrist University Hospital. Not yet recruiting. Open to participants aged 3 Months to 8 Months. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Balgrist University Hospital · Observational

Updated Oct 8, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
10
Ages
3 Months to 8 Months
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Torticollis (Arthrogenic)

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Keywords

  • Infant
  • Cervical range of motion
  • arthrogenic torticollis
  • feasibility
  • Intertial measurement unit
03

In context

Torticollis

139 studies on the registry are indexed under Torticollis; 21 are open to participants now.

This study's planned enrollment of 10 is below the median of 50 across 44 observational studies indexed under Torticollis.

Browse Torticollis studies →

Lead sponsor

Balgrist University Hospital is the lead sponsor of 80 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 8 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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 measurements independently
  • Excessive distress or resistance by the infant, such as crying, screaming, or similar reactions
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Other: Mobilisation of the upper cervical spine (but the effectiveness of the investigation is not part of the study evaluation)

Interventions

  • OtherMobilisation 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to end of data collection = 5 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Also revised
primary outcomes
Registered
First appeared on the registry
Oct 2, 2026
Show all 2 updates
  1. Oct 8, 2026
    Primary outcomes Revised (1 change)
    + 2 other changes: verification date and description
  2. Oct 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07855731
Lead sponsor
Balgrist University Hospital
Responsible party
Schweinhardt Petra (Prof. Dr. med, Balgrist University Hospital) — Principal investigator
First posted
Oct 2, 2026
Start date
Oct 7, 2026 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Anke Langenfeld, PhD
Contact
anke.langenfeld@balgrist.ch
+ 41 44 386 ext. 57 30
Petra Schweinhardt, PhD
study chair · Balgrist University Hospital and University of Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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