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 range

5 Years – 15 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

5 Years – 15 Years

Sex

ALL

See this in plain English?

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