Gait Analysis in Ponseti Clubfoot

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

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.

Study Overview

• Status: Completed
• Conditions: Clubfoot

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1130
    • Orthopaedic Hospital Speising

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
control group; healthy children of employees of our hospital
study group; Patients with a minimum age of three years from our prospective, consecutive database of patients with clubfoot treated with the Ponseti method beginning in 2002 are considered for this study. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D Gait Analysis with foot model	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical examination	Active and passive range of motion (ROM) of the ankle joint measured with a hand-held goniometer. Ability to walk on the heels and on tiptoes.	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	questionnaire as described in citation	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

Collaborators and Investigators

• Sponsor: Orthopedic Hospital Vienna Speising
• Investigators: Principal Investigator: Christof Radler, MD, Orthopaedic Hospital Speising

Publications and helpful links

General Publications

• Roye BD, Vitale MG, Gelijns AC, Roye DP Jr. Patient-based outcomes after clubfoot surgery. J Pediatr Orthop. 2001 Jan-Feb;21(1):42-9. doi: 10.1097/00004694-200101000-00010.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: December 7, 2013
• First Submitted That Met QC Criteria: December 20, 2013
• First Posted (Estimate): December 27, 2013

Study Record Updates

• Last Update Posted (Estimate): December 27, 2013
• Last Update Submitted That Met QC Criteria: December 20, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: gait analysis; clubfoot; outcome questionaire; Ponseti method
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity; Foot Deformities
• Other Study ID Numbers: EK10-218-1210