TorticollisNCT00879450
Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
A study testing Booklet in people with Torticollis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Torticollis
- What is being tested?
- Booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Torticollis
- Being tested
- Booklet
- Keywords
- Congenital muscular torticollis
- Medical subject headings
- Torticollis, Congenital torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BookletOther
booklet given to parents for home exercises
| Study group | Role | What they receive |
|---|---|---|
| 1 Booklet | Experimental | Not described Receives: Other: Booklet |
| 2 standard | Active comparator | Not described Receives: Other: Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck range of motion measurements
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionJul 2011
Why it stopped: Clinical department where study was held was unable to continue collaboration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TorticollisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879450
- Sponsor's protocol ID
- PED-08-035
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2009
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
- ClinicalTrials.gov ID
- NCT00879450
- Acronym / sponsor ID
- PED-08-035
- Conditions
- Torticollis
- Keywords
- Congenital muscular torticollis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical department where study was held was unable to continue collaboration
- Enrolment
- 160 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Booklet | Experimental | Other: Booklet |
| 2 standard | Active comparator | Other: Booklet |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bookletbooklet given to parents for home exercises | Other | 1 Booklet, 2 standard |
Primary outcome
Neck range of motion measurements
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Clinical department where study was held was unable to continue collaboration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Booklet in people with Torticollis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Clinical department where study was held was unable to continue collaboration). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck range of motion measurements (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019; AzTrials last refreshed its copy on 31 Oct 2026.