Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking
Phase 2
Completed
- Conditions
- Idiopathic Toe Walking
- Registration Number
- NCT00175669
- Lead Sponsor
- University of British Columbia
- Brief 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.
- Detailed Description
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 will be eligible for the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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. Data not known
- Secondary Outcome Measures
Name Time Method Ankle range of motion (dorsiflexion and plantarflexion) collected at every visit
Trial Locations
- Locations (1)
BC Children's Hospital, Department of Orthopaedics
🇨🇦Vancouver, British Columbia, Canada