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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:
ClinicalTrials.gov Identifier:
NCT00879450
First Posted: April 10, 2009
Last Update Posted: July 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
McGill University Health Center
April 7, 2009
April 10, 2009
July 21, 2011
May 2009
June 2011   (Final data collection date for primary outcome measure)
Neck range of motion measurements [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT00879450 on ClinicalTrials.gov Archive Site
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Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Torticollis
Other: Booklet
booklet given to parents for home exercises
  • Experimental: 1 Booklet
    Intervention: Other: Booklet
  • Active Comparator: 2 standard
    Intervention: Other: Booklet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
July 2011
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 6 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00879450
PED-08-035
Yes
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Isabelle Gagnon, Researcher Montreal Children's Hospital, Montreal Children's Hospital of the McGill University Health Center
McGill University Health Center
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Not Provided
McGill University Health Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP