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

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175669
First received: September 13, 2005
Last updated: April 11, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Idiopathic Toe Walking
 Drug: Botox injections
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ankle range of motion (dorsiflexion and plantarflexion) [ Time Frame: collected at every visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: August 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Botox injections
    Data not known.
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.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175669

Locations
Canada, British Columbia
BC Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Christine Alvarez, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Christine Alvarez, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175669     History of Changes
Other Study ID Numbers: C00-0160, CW: 00-0500
Study First Received: September 13, 2005
Last Updated: April 11, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Randomized control trial; placebo-control study

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013