Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Toe Walking
Intervention: Botox injections (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Christine Alvarez, MD, Principal Investigator, Affiliation: University of British Columbia
Overall contact:
Harpreet Chhina, Phone: 604-875-2000, Ext: 6008, Email: hchhina@cw.bc.ca
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.
Clinical Details
Official title: Randomized Controlled Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: Ankle range of motion (dorsiflexion and plantarflexion)
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.
Eligibility
Minimum age: 5 Years.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Harpreet Chhina, Phone: 604-875-2000, Ext: 6008, Email: hchhina@cw.bc.ca
BC Children's Hospital, Department of Orthopaedics, Vancouver, British Columbia V6H 3V4, Canada; Recruiting
Harpreet Chhina, Phone: 604-875-2000, Ext: 6008, Email: hchhina@cw.bc.ca
Christine Alvarez, PhD, Principal Investigator
Additional Information
Starting date: August 2007
Ending date: December 2010
Last updated: November 10, 2008
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