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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-8
SponsorBalgrist University Hospital

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

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 intervention

    Mobilisation of the upper cervical spine (C1/C2).

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Infants with athrogenic torticollis1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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