Back to resultsEvaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
Primary Purpose
Torticollis
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Booklet
Sponsored by
About this trial
This is an interventional treatment trial for Torticollis focused on measuring Congenital muscular torticollis
Eligibility 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.
Sites / Locations
- Montreal Children's Hospital, MUHC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 Booklet
2 standard
Arm Description
Outcomes
Primary Outcome Measures
Neck range of motion measurements
Secondary Outcome Measures
Full Information
NCT ID
NCT00879450
First Posted
April 7, 2009
Last Updated
April 2, 2019
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT00879450
Brief Title
Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
Official Title
Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Clinical department where study was held was unable to continue collaboration
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Torticollis
Keywords
Congenital muscular torticollis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Booklet
Arm Type
Experimental
Arm Title
2 standard
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Booklet
Intervention Description
booklet given to parents for home exercises
Primary Outcome Measure Information:
Title
Neck range of motion measurements
Time Frame
3 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Montreal Children's Hospital, MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
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