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

This study is currently recruiting participants.

Verified by University of British Columbia, November 2008

First Received: September 13, 2005 Last Updated: November 10, 2008 History of Changes

Sponsor:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175669

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Contacts

Contact: Harpreet Chhina

604-875-2000 ext 6008

hchhina@cw.bc.ca

Locations

Canada, British Columbia
BC Children's Hospital, Department of Orthopaedics	Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Harpreet Chhina 604-875-2000 ext 6008 hchhina@cw.bc.ca
Principal Investigator: Christine Alvarez, PhD

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Christine Alvarez, MD

University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia ( Dr. Christine Alvarez )
Study ID Numbers:	C00-0160, CW: 00-0500
Study First Received:	September 13, 2005
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00175669 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Randomized control trial; placebo-control study

Additional relevant MeSH terms:

Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Botulinum Toxin Type A
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010