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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
  Purpose
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.

Condition Intervention
Torticollis Other: Booklet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Neck range of motion measurements [ Time Frame: 3 months ]

Estimated Enrollment: 160
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Booklet Other: Booklet
booklet given to parents for home exercises
Active Comparator: 2 standard Other: Booklet
booklet given to parents for home exercises

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879450


Locations
Canada, Quebec
Montreal Children's Hospital, MUHC
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
McGill University Health Center
  More Information

Responsible Party: Isabelle Gagnon, Researcher Montreal Children's Hospital, Montreal Children's Hospital of the McGill University Health Center
ClinicalTrials.gov Identifier: NCT00879450     History of Changes
Other Study ID Numbers: PED-08-035
First Submitted: April 7, 2009
First Posted: April 10, 2009
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by McGill University Health Center:
Congenital muscular torticollis

Additional relevant MeSH terms:
Torticollis
Dystonic Disorders
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dystonia
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs