Passive Cervical Range of Motion in Infants

Arthrogenic Torticollis Clinical Trial

— CROMinfants  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981782
• Other study ID #: 2020-02328
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2023
• Source: Balgrist University Hospital
• Contact: Petra Schweinhardt, PhD
• Phone: +41(0)44510
• Email: petra.schweinhardt[@]balgrist.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: August 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Arthrogenic Torticollis
• Torticollis

Intervention

Other:
• No study specific intervention, regular care.
Chiropractic care (regular care)

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich
Switzerland	Balgrist University Hospital	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	passive cervical range of motion (pCROM)	The ability of passive movement of the cervical spine will be assessed	baseline
Primary	passive cervical range of motion (pCROM)	The ability of passive movement of the cervical spine will be assessed	three months
Primary	passive cervical range of motion (pCROM)	The ability of passive movement of the cervical spine will be assessed	six months
Primary	passive cervical range of motion (pCROM)	The ability of passive movement of the cervical spine will be assessed	four months
Primary	passive cervical range of motion (pCROM)	The ability of passive movement of the cervical spine will be assessed	nine months
Secondary	Demographic data child	specific data of the child is gathered	baseline
Secondary	Demographic data mother	specific data of the mother is collected	baseline