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

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McGill University

Status

Terminated

Conditions

Torticollis

Treatments

Other: Booklet

Study type

Interventional

Funder types

Other

Identifiers

NCT00879450
PED-08-035

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

All

Ages

Under 6 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups

1 Booklet
Experimental group
Treatment:
Other: Booklet
2 standard
Active Comparator group
Treatment:
Other: Booklet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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