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

April 2, 2019 updated by: Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's hospital, MUHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neck range of motion measurements
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria

April 9, 2009

First Posted (Estimate)

April 10, 2009

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED-08-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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