Passive Cervical Range of Motion in Infants (CROMinfants)

August 21, 2024 updated by: Balgrist University Hospital

Passive Cervical Range of Motion in Infants With and Without Torticollis, Before, During and After Chiropractic Treatment

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infants at the age of 2 to 12 month will be measured at several time points to assess their passive cervical range of motion. One group will include healthy subjects, the other group infants with a diagnosed torticollis. Healthy subjects will be measured at the age of 3, 4, 6 and 9 months. Infants diagnosed with torticollis, at their visit at a Chiropractor and one week later.

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • Balgrist University Hospital
    • Zurich
      • Zürich, Zurich, Switzerland, 8008
        • Balgrist University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

infants with torticollis

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Chiropractic care (regular care)
Other Names:
  • chiropractic treatment
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.
Chiropractic care (regular care)
Other Names:
  • chiropractic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
passive cervical range of motion (pCROM)
Time Frame: baseline
The ability of passive movement of the cervical spine will be assessed
baseline
passive cervical range of motion (pCROM)
Time Frame: three months
The ability of passive movement of the cervical spine will be assessed
three months
passive cervical range of motion (pCROM)
Time Frame: six months
The ability of passive movement of the cervical spine will be assessed
six months
passive cervical range of motion (pCROM)
Time Frame: four months
The ability of passive movement of the cervical spine will be assessed
four months
passive cervical range of motion (pCROM)
Time Frame: nine months
The ability of passive movement of the cervical spine will be assessed
nine months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic data child
Time Frame: baseline
specific data of the child is gathered
baseline
Demographic data mother
Time Frame: baseline
specific data of the mother is collected
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Investigators

  • Study Chair: Petra Schweinhardt, PhD, University of Zürich and Balgrist University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-02328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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