Clubfoot Clinical Trial
Official title:
Results of Gait Analysis Including Oxford Foot Model in Children With Clubfoot Treated With the Ponseti Method
Verified date | December 2013 |
Source | Orthopedic Hospital Vienna Speising |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Ethikkommission |
Study type | Observational |
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.
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Austria | Orthopaedic Hospital Speising | Vienna |
Lead Sponsor | Collaborator |
---|---|
Orthopedic Hospital Vienna Speising |
Austria,
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
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 |
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