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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00879450
Other study ID # PED-08-035
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 2009
Est. completion date July 2011

Study information

Verified date April 2019
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Children with a torticollis are usually referred for physiotherapy where they are evaluated, and given exercises as well as education to treat the condition. This study is being done in order to compare 2 methods of sharing information with parents of children with torticollis.


Description:

160 children of less than 6 months of age will be recruited for the study and divided in 2 groups. Children of both groups will receive the same physiotherapy evaluation and exercises but parents will receive information handouts with one of two different types of illustrations and written instructions for home exercises.


Recruitment information / eligibility

Status Terminated
Enrollment 160
Est. completion date July 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility Inclusion Criteria:

- Aged newborn to 6 months at initial visit in physiotherapy,

- A diagnosis of PT made by a physician,

- At least 37 weeks of gestational age at delivery

Exclusion Criteria:

- Congenital muscular torticollis with fibrosis (confirmed diagnosis): because this is a rare condition that has a different rate of recovery,

- Presence of craniosynostosis (confirmed diagnosis made by a neurosurgeon),

- APGAR score of less than 7 at 5 minutes,

- Prescription of a Tubular Orthosis for Torticollis (TOT) collar or Botox intervention for the torticollis,

- Confirmed diagnosis of syndrome or neurological condition.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Booklet
booklet given to parents for home exercises

Locations

Country Name City State
Canada Montreal Children's Hospital, MUHC Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck range of motion measurements 3 months
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