NCT00175669

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.9 years until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

April 12, 2011

Status Verified

April 1, 2011

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

April 11, 2011

Conditions

Idiopathic Toe Walking

Keywords

Randomized control trial; placebo-control study

Outcome Measures

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.

    Data not known

Secondary Outcomes (1)

  • Ankle range of motion (dorsiflexion and plantarflexion)

    collected at every visit

Interventions

Botox injectionsDRUG

Data not known.

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital, Department of Orthopaedics

Vancouver, British Columbia, V6H 3V4, Canada

Location

Study Officials

  • Christine Alvarez, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

August 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

April 12, 2011

Record last verified: 2011-04

Locations

CA(1)