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Function and participation of children with Ponseti treated clubfoot

Function and participation of children with Ponseti treated clubfoot

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25499
Enrollment
90
Registered
2021-07-08
Start date
2021-08-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

clubfoot / relapse clubfoot

Interventions

None listed

Sponsors

Raad van bestuur Máxima MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Maximum plantar flexion at toe-off obtained with 3DGA during walking

Secondary

MeasureTime frame
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.

Contacts

Public ContactMaria van der Steen

Máxima MC / Catharina ziekenhuis

marieke.vander.steen@mmc.nl040-8885257

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)