Gait Analysis in Ponseti Clubfoot

NCT02022267 | Completed

• 1 other identifier: EK10-218-1210
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Clubfoot

Keywords

clubfoot; gait analysis; outcome questionaire; Ponseti method

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (2)

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.

control group

healthy children of employees of our hospital

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• unilateral or bilateral idiopathic clubfoot treated with the Ponseti method

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthopedic Hospital Vienna Speising: lead

Study Sites (1)

Orthopaedic Hospital Speising

Vienna, 1130, Austria

Location

Related Publications (1)

• 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.

  PMID: 11176352 BACKGROUND

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christof Radler, MD

  Orthopaedic Hospital Speising

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof., MD

Study Record Dates

• First Submitted: December 7, 2013
• First Posted: December 27, 2013
• Study Start: October 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 27, 2013

Record last verified: 2013-12

Locations

AU (1)