Evaluating the Impact of a New Complement to Physiotherap... | NCT00879450

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

NCT00879450

Sponsor

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

Status

Terminated

Last Update Posted

Apr 4, 2019Actual

Enrollment

160Actual

Phase

Not Applicable

Conditions

Torticollis

Interventions

Booklet

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Clinical department where study was held was unable to continue collaboration

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Apr 7, 2009

First Submission Date that Met QC Criteria

Apr 9, 2009

First Posted Date

Apr 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2019

Last Update Posted Date

Apr 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Isabelle Gagnon, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health CentrePrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 Booklet	Experimental		Other: Booklet
2 standard	Active Comparator		Other: Booklet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Booklet	Other	booklet given to parents for home exercises	1 Booklet 2 standard

Measure	Description	Time Frame
Neck range of motion measurements		3 months

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montreal Children's Hospital, MUHC		Montreal	Quebec	H3H 1P3	Canada

Condition Browse Module

MeSH Terms

ID	Term
D014103	Torticollis
C535425	Congenital torticollis

Ancestor Terms

ID	Term
D004421	Dystonia
D020820	Dyskinesias
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided