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

Idiopathic Toe Walking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175669
• Other study ID #: C00-0160
• Secondary ID: CW: 00-0500
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 11, 2011
• Start date: August 2007
• Est. completion date: November 2009

Study information

• Verified date: April 2011
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Toe Walking

Intervention

Drug:
• Botox injections
Data not known.

Locations

Country	Name	City	State
Canada	BC Children's Hospital, Department of Orthopaedics	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Ankle range of motion (dorsiflexion and plantarflexion)		collected at every visit	No