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Completed

NCT Number: NCT00175669

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

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.

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Key information

Conditions

Idiopathic Toe Walking

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BC Children's Hospital, Department of Orthopaedics

Vancouver, British Columbia, V6H 3V4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botox injections

Drug

Data not known.

Primary outcomes

  1. 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

Secondary outcomes

  1. Ankle range of motion (dorsiflexion and plantarflexion)

    Time frame: collected at every visit

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 15, 2005
Registry last updated
Apr 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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