NCT00879450

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2009

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

April 7, 2009

Last Update Submit

April 2, 2019

Conditions

Torticollis

Keywords

Congenital muscular torticollis

Outcome Measures

Primary Outcomes (1)

  • Neck range of motion measurements

    3 months

Study Arms (2)

1 Booklet

EXPERIMENTAL
Other: Booklet

2 standard

ACTIVE COMPARATOR
Other: Booklet

Interventions

BookletOTHER

booklet given to parents for home exercises

1 Booklet2 standard

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Children's Hospital, MUHC

Montreal, Quebec, H3H 1P3, Canada

Location

MeSH Terms

Conditions

TorticollisCongenital torticollis

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 10, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

CA(1)