Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants

This study has been terminated.

(Clinical department where study was held was unable to continue collaboration)

Sponsor:

Information provided by:

McGill University Health Center

ClinicalTrials.gov Identifier:

NCT00879450

First received: April 7, 2009

Last updated: July 19, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 7, 2009
Last Updated Date	July 19, 2011
Start Date ^ICMJE	May 2009
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 9, 2009)	Neck range of motion measurements [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00879450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
Official Title ^ICMJE	Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
Brief 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.
Detailed 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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Torticollis
Intervention ^ICMJE	Other: Booklet booklet given to parents for home exercises
Study Arm (s)	Experimental: 1 Booklet Intervention: Other: Booklet Active Comparator: 2 standard Intervention: Other: Booklet
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	160
Completion Date	July 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	up to 6 Months
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT00879450
Other Study ID Numbers ^ICMJE	PED-08-035
Has Data Monitoring Committee	Yes
Responsible Party	Isabelle Gagnon, Researcher Montreal Children's Hospital, Montreal Children's Hospital of the McGill University Health Center
Study Sponsor ^ICMJE	McGill University Health Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	McGill University Health Center
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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