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

University of British Columbia1 site in 1 country32 target enrollmentAugust 2007

ConditionsIdiopathic Toe Walking

DrugsBotox injections

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Idiopathic Toe Walking
Sponsor: University of British Columbia
Enrollment: 32
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

November 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of British Columbia

Eligibility 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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.

Time Frame: Data not known