CompletedPhase 2

Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking

Canada32 participantsStarted 2007-08

Plain-language summary

The purpose of this study is to compare the effect of Botox and casting to placebo and casting for reducing toe walking problems in children who are idiopathic toe walkers.

Who can participate

Age range5 Years – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who have been seen by one of the 5 paediatric orthopaedic surgeons at British Columbia's Children's Hospital and have been referred to the Shriner's gait lab for assessment of idiopathic toe walking * Clinical toe walkers - toe walkers as per gait lab's definition (loss of 1st ankle rocker, early heel rise \[prior to 30% of the cycle\] and A1 kinematic data) * Aged 5 - 15 years old * Parents and patients educated about protocol and willing to partake * Cooperative patient with gait analysis and injection

What they're measuring

The primary outcome will be based on gait analysis data - specifically whether post injection gait analyses show a reduction in the features that were used to determine the severity of the subjects' toe walking problem.

Timeframe: Data not known

Trial details

NCT IDNCT00175669

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

View on ClinicalTrials.gov More Idiopathic Toe Walking trials