Health-Related Quality of Life in Children and Adolescents With Clubfoot

NCT ID: NCT06906406

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2030-12-31

Brief Summary

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This prospective cohort study aims to evaluate the health-related quality of life (HRQoL) in children aged 2 to 15 years with congenital clubfoot, treated primarily according to the Ponseti method. The study will assess HRQoL using the Pediatric Quality of Life Inventory (PedsQL 4.0) and clinical outcomes using the PBS Clubfoot Score (PBS). Participants will be followed for 2 and 5 years to evaluate changes in HRQoL and clinical function. The primary objective is to understand the long-term impact of clubfoot and its treatment on patients' physical, emotional, and social well-being.

Detailed Description

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Conditions

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Clubfoot Children HRQOL (Health Related Quality Of Life)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Children aged 2 to 15 years diagnosed with congenital clubfoot.
* Undergoing treatment or follow-up at Drammen Hospital.
* Both unilateral and bilateral cases included.
* Written informed consent from parents or legal guardians.

Exclusion Criteria

* Concurrent severe medical or psychological conditions affecting outcomes.
* Lack of written informed consent.
* Incomplete or missing data for PedsQL or PBS assessments.
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vestreviken

Drammen, Buskerud, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Per Reidar Høiness, MD PhD

Role: CONTACT

+47 97527911

Facility Contacts

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Per Reidar Høiness, MD PhD

Role: primary

+47 97527911

Other Identifiers

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1000323

Identifier Type: -

Identifier Source: org_study_id

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