Gait Analysis in Ponseti Clubfoot

Clubfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022267
• Other study ID #: EK10-218-1210
• Status: Completed
• Phase: N/A
• First received: December 7, 2013
• Last updated: December 20, 2013
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: Orthopedic Hospital Vienna Speising
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity

Locations

Country	Name	City	State
Austria	Orthopaedic Hospital Speising	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Orthopedic Hospital Vienna Speising

Country where clinical trial is conducted

Austria, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No