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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Torticollis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1 Booklet

Group Type EXPERIMENTAL

Booklet

Intervention Type OTHER

booklet given to parents for home exercises

2 standard

Group Type ACTIVE_COMPARATOR

Booklet

Intervention Type OTHER

booklet given to parents for home exercises

Interventions

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Booklet

booklet given to parents for home exercises

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No