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Clinical Trials/NCT02022267
NCT02022267
Completed
Not Applicable

Results of Gait Analysis Including Oxford Foot Model in Children With Clubfoot Treated With the Ponseti Method

Orthopedic Hospital Vienna Speising1 site in 1 country51 target enrollmentOctober 2011
ConditionsClubfoot

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Clubfoot
Sponsor
Orthopedic Hospital Vienna Speising
Enrollment
51
Locations
1
Primary Endpoint
3D Gait Analysis with foot model
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Patients with clubfoot treated with the Ponseti method from a prospective database are evaluated using gait analysis including a foot model and a disease specific instrument score and compared to a group of healthy children.

Detailed Description

Patients with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method beginning in 2002 are considered for this study. Thereby patients will typically have a follow up of nearly three to eight years after initial clubfoot correction. Patients with unilateral or bilateral idiopathic clubfoot are included. Patients with clubfoot associated with syndromes or neurological diseases, with mild clubfoot that required fewer than three casts for initial correction, who first presented at an age older than three months, who were living outside of the country, and who were initially treated elsewhere with more than three casts are excluded. An invitation letter to participate in the study was sent out at the end of 2011, with a second letter being sent out three months after the first. After the second letter patients had a time frame of three more months to participate before the study was closed. To comprise a control group for the purpose of collecting gait analysis data of healthy children, employees of our hospital are asked to allow their children to participate in this study. Each patient will be physically examined, active and passive range of motion (ROM) of the ankle joint will be measured with a hand-held goniometer. Ability to walk on the heels and on tiptoes will be recorded. The disease-specific instrument questionnaire, which will be blinded for the treating physician will be handed out to fill in. Patients will undergo gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
September 2012
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Orthopedic Hospital Vienna Speising
Responsible Party
Principal Investigator
Principal Investigator

Christof Radler

Assoc. Prof., MD

Orthopedic Hospital Vienna Speising

Eligibility Criteria

Inclusion Criteria

  • unilateral or bilateral idiopathic clubfoot treated with the Ponseti method

Exclusion Criteria

  • clubfoot associated with syndromes or neurological diseases
  • mild clubfoot that required fewer than three casts for initial correction
  • clubfoot patients that first presented at an age older than three months
  • clubfoot patients who were living outside of the Country
  • clubfoot patients who were treated elsewhere with more than three casts

Outcomes

Primary Outcomes

3D Gait Analysis with foot model

Time Frame: once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed

Gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.

Secondary Outcomes

  • Clinical examination(once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed)
  • disease-specific instrument questionnaire(once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed)

Study Sites (1)

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