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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:
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

April 7, 2009
July 19, 2011
May 2009
June 2011   (final data collection date for primary outcome measure)
Neck range of motion measurements [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00879450 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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: Double Blind (Subject, Caregiver, 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
Not Provided

*   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.
Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00879450
PED-08-035
Yes
Isabelle Gagnon, Researcher Montreal Children's Hospital, Montreal Children's Hospital of the McGill University Health Center
McGill University Health Center
Not Provided
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