ClubfootNCT06906406
Health-Related Quality of Life in Children and Adolescents With Clubfoot
An observational study of Clubfoot and Children, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Clubfoot, Children, HRQOL (Health Related Quality Of Life)
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: This study investigates the impact of congenital clubfoot and its treatment on the health-related quality of life (HRQoL) in children using a prospective cohort design. The participants will be evaluated using the Pediatric Quality of Life Inventory (PedsQL 4.0) to assess HRQoL and the PBS Clubfoot Score (PBS) for clinical outcomes. Assessments will occur at baseline, 2 years, and 5 years post-treatment initiation. Data collection will include clinical evaluations, standardized HRQoL questionnaires, and Visual Analogue Scale (VAS) assessments for pain and satisfaction. The findings will help optimize treatment protocols for clubfoot by providing comprehensive insights into how different treatment methods impact children's quality of life.
Who may be able to join
- 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.
Who cannot join
- Concurrent severe medical or psychological conditions affecting outcomes.
- Lack of written informed consent.
- Incomplete or missing data for PedsQL or PBS assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Vestreviken
Drammen, Buskerud, 3004
Per Reidar Høiness, MD PhD, +47 97527911, prhoines@vestreviken.no
About this study
Official title: Health-Related Quality of Life in Children and Adolescents With Clubfoot. A Prospective Observational Study
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.
- Conditions
- Clubfoot, Children, HRQOL (Health Related Quality Of Life)
- Keywords
- HRQoL, PedsQL, Children, Clubfoot, Ponseti
- Medical subject headings
- Clubfoot
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL Score
Health-Related Quality-of-Life (HRQoL) score as measured by The Pediatric Quality of Life Inventory™ (PedsQL) 4.0, assessing physical, emotional, social, and school functioning. Scored on a scale from 0 to 100, with higher scores indicating better HRQoL.
Measured: Baseline, then at every follow-up over the study period of a total of 5 years.
Secondary outcomes (3)
PBS Clubfoot Score
The PBS (Ponseti, Barlow, and Stagnara) Clubfoot Score assesses clinical function, including foot shape, range of motion, and muscle balance. The score ranges from 7 to 18 points, in which a low score indicates good function, and a high score indicates poor function.
Measured: Baseline, then at every follow-up over the study period of a total of 5 years.
Pain Assessment
Pain Assessment: Visual Analogue Scale (VAS) score ranging from 0 (no pain) to 100 (worst pain imaginable).
Measured: Baseline, then at every follow-up over the study period of a total of 5 years.
Satisfaction Assessment
Satisfaction Assessment: Visual Analogue Scale (VAS) score for patient and parent satisfaction with treatment outcomes, ranging from 0 (not satisfied) to 100 (completely satisfied).
Measured: Baseline, then at every follow-up over the study period of a total of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906406
- Sponsor's protocol ID
- 1000323
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life in Children and Adolescents With Clubfoot. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06906406
- Acronym / sponsor ID
- 1000323
- Conditions
- Clubfoot, Children, HRQOL (Health Related Quality Of Life)
- Keywords
- HRQoL, PedsQL, Children, Clubfoot, Ponseti
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study investigates the impact of congenital clubfoot and its treatment on the health-related quality of life (HRQoL) in children using a prospective cohort design. The participants will be evaluated using the Pediatric Quality of Life Inventory (PedsQL 4.0) to assess HRQoL and the PBS Clubfoot Score (PBS) for clinical outcomes. Assessments will occur at baseline, 2 years, and 5 years post-treatment initiation. Data collection will include clinical evaluations, standardized HRQoL questionnaires, and Visual Analogue Scale (VAS) assessments for pain and satisfaction. The findings will help optimize treatment protocols for clubfoot by providing comprehensive insights into how different treatment methods impact children's quality of life.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Concurrent severe medical or psychological conditions affecting outcomes.
- Lack of written informed consent.
- Incomplete or missing data for PedsQL or PBS assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HRQoL Score
Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.
Health-Related Quality-of-Life (HRQoL) score as measured by The Pediatric Quality of Life Inventory™ (PedsQL) 4.0, assessing physical, emotional, social, and school functioning. Scored on a scale from 0 to 100, with higher scores indicating better HRQoL.
3 secondary outcomes
PBS Clubfoot Score
Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.
Pain Assessment
Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.
Satisfaction Assessment
Time frame: Baseline, then at every follow-up over the study period of a total of 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot and Children, run by Vestre Viken Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Per Reidar Høiness, MD PhD (+47 97527911, prhoines@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL Score (time frame: Baseline, then at every follow-up over the study period of a total of 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.