Gait Analysis in Ponseti Clubfoot

NCT ID: NCT02022267

Last Updated: 2013-12-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-09-30

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.

Conditions

Clubfoot

Keywords

clubfoot; gait analysis; outcome questionaire; Ponseti method

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

control group

healthy children of employees of our hospital

No interventions assigned to this group

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orthopedic Hospital Vienna Speising

OTHER

Sponsor Role: lead

Responsible Party

Christof Radler

Assoc. Prof., MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christof Radler, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Hospital Speising

Locations

Orthopaedic Hospital Speising

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 11176352 (View on PubMed)

Other Identifiers

EK10-218-1210

Identifier Type: -

Identifier Source: org_study_id