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

University of British Columbia logo

University of British Columbia

Status and phase

Completed
Phase 2

Conditions

Idiopathic Toe Walking

Treatments

Drug: Botox injections

Study type

Interventional

Funder types

Other

Identifiers

NCT00175669
CW: 00-0500
C00-0160

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 estimated patients

Sex

All

Ages

5 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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