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

NCT07855731 | Not Yet Recruiting

• 1 other identifier: 2026-01419
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Babies with torticollis (a tilted or twisted neck) have difficulty turning their head fully to the side. Small movement sensors (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.

Conditions

Torticollis (Arthrogenic)

Keywords

Infant; Cervical range of motion; arthrogenic torticollis; feasibility; Intertial measurement unit

Outcome Measures

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.

  FRom enrollment to end of data collection = 5 days

Study Arms (1)

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

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).

Infants with athrogenic torticollis

Eligibility Criteria

• Age: 3 Months - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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-

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Petra Schweinhardt, PhD

  Balgrist University Hospital and University of Zurich

  STUDY CHAIR

Central Study Contacts

Anke Langenfeld, PhD

CONTACT

+ 41 44 386; anke.langenfeld@balgrist.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 7, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share