NCT04981782

Brief Summary

Infants with and without torticollis will be measured at different time points to assess their passive cervical spine range of motion (pCROM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

July 20, 2021

Last Update Submit

August 21, 2024

Conditions

Keywords

arthrogenic Torticolliscervical range of motioninfant

Outcome Measures

Primary Outcomes (5)

  • passive cervical range of motion (pCROM)

    The ability of passive movement of the cervical spine will be assessed

    baseline

  • passive cervical range of motion (pCROM)

    The ability of passive movement of the cervical spine will be assessed

    three months

  • passive cervical range of motion (pCROM)

    The ability of passive movement of the cervical spine will be assessed

    six months

  • passive cervical range of motion (pCROM)

    The ability of passive movement of the cervical spine will be assessed

    four months

  • passive cervical range of motion (pCROM)

    The ability of passive movement of the cervical spine will be assessed

    nine months

Secondary Outcomes (2)

  • Demographic data child

    baseline

  • Demographic data mother

    baseline

Study Arms (2)

healthy subjects

No intervention Infants will be measured at different time points. At the age of 3,4,6 and 9 months.

Other: No study specific intervention, regular care.

torticollis group

No intervention Infants will be measured at their visit to a Chiropractor. Before and after treatment.

Other: No study specific intervention, regular care.

Interventions

Chiropractic care (regular care)

Also known as: chiropractic treatment
healthy subjectstorticollis group

Eligibility Criteria

Age2 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

infants with torticollis

You may qualify if:

  • age 2-12 month
  • signed informed consent
  • diagnosed with torticollis

You may not qualify if:

  • defense reaction e.g. crying, screaming
  • other illnesses
  • neck trauma
  • neck surgery
  • developmental delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Langenfeld A, Paravicini I, Hobaek Siegenthaler M, Wehrli M, Hausler M, Bergander T, Schweinhardt P. Subjective and Objective Assessment of the Preferred Rotational Cervical Spine Position in Infants with an Upper Cervical Spine Dysfunction: A Cross-Sectional Study. Children (Basel). 2024 Dec 13;11(12):1515. doi: 10.3390/children11121515.

Study Officials

  • Petra Schweinhardt, PhD

    University of Zurich and Balgrist University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 29, 2021

Study Start

November 1, 2021

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations