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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00175669
Enrollment
32
Registered
2005-09-15
Start date
2007-08-31
Completion date
2009-11-30
Last updated
2011-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Toe Walking

Keywords

Randomized control trial; placebo-control study

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.

Interventions

DRUGBotox injections

Data not known.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Ankle range of motion (dorsiflexion and plantarflexion)collected at every visit

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026