Function and participation of children with Ponseti treated clubfoot

Recruiting

Conditions: gezonde kinderen
clubfoot
talipes equinovarus
10028396

Registration Number: NL-OMON51193

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

Both controls and (relapse) clubfoot patients who:
- Are 5 - 9 years old
- Have parents with sufficient command of the Dutch language

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.

Exclusion Criteria

Both controls and (relapse) clubfoot patients who:
- Are unable to follow the instructions
- Have obesity, based on their age-category and gender
- 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
<p>Maximum plantar flexion at toe-off obtained with 3DGA during walking.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Mean PEM-CY, motor competence, M-ABC 2, and CAP scores of the different study<br /><br>groups. Furthermore, secondary study parameters are: kinematic, and kinetic<br /><br>parameters from the foot, ankle, knee and hip and muscle activity.</p><br>

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