Function and participation of children with Ponseti treated clubfoot
- Conditions
- clubfoot / relapse clubfoot
- Registration Number
- NL-OMON25499
- Lead Sponsor
- Raad van bestuur Máxima MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
Both controls and (relapse) clubfoot patients who:
- Are 5 - 9 years old
- Have parents with sufficient command of the Dutch language
(Relapse) Clubfoot patients who:
- Have idiopathic clubfoot
- Are uni- or bilaterally affected
- Have been primarily treated with the Ponseti method
Relapse clubfoot patients:
- Reoccurrence of one or more clubfoot aspects that requires additional
treatment as judged by the expert opinion of the treating orthopaedic
surgeon. Additional treatment according to regular care includes:
• Non-invasive treatment with physiotherapy,
• Surgical treatment, consisting of a period of bracing followed by
one of the following surgical procedures: a tibialis anterior
tendon transfer (TATT), anterior distal tibial epiphysiodesis (8-
plate), or a combination of both procedures.
Both controls and (relapse) clubfoot patients who:
- Are unable to follow the instructions
- Have obesity
- Have an underlying syndrome
- Have a neurological disease
Controls who:
- Have problems of the lower extremity
(e.g., hip dysplasia/ broken leg <1year prior to participation)
All clubfoot patients who:
- Did not have their primary treatment in the Netherlands
- Previously received additional surgical treatment (with exception of re-Achilles tendon tenotomy) for a relapse of their clubfoot.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum plantar flexion at toe-off obtained with 3DGA during walking
- Secondary Outcome Measures
Name Time Method Secondary parameters from the gait analysis are kinematics and kinetics from the foot, ankle, knee and hip during functional activities, and muscle activity. Other secondary parameters are the total and/or sub-scores obtained with the questionnaire on perceived motor competence, CAP, PEM-CY, M-ABC 2 checklist and test.