About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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-
Disqualifiers
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
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
Mobilisation of the upper cervical spine (but the effectiveness of the investigation is not part of the study evaluation)
Other interventionMobilisation of the upper cervical spine (C1/C2).
Treatment groups
Trial outcomes
Primary outcomes
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.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: