ClubfootNCT06050746
Predictive Value of the PBS-score in Children With Clubfoot
An observational study of Clubfoot, run by Region Stockholm at 1 site in Sweden.
Trial summary
Evaluate the predictive value of the PBS-score in predicting recurrence of idiopathic clubfoot, measured as need for additional treatment. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Clubfoot
- What is being tested?
- Systematic screening
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2023to 30 Jun 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with idopatic clubfoot treated at Astrdi lindgren Children´s Hospital
Who may be able to join
- age 4-10 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English.
Who cannot join
- Syndromic clubfoot
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Astrid Lindgren Children´s Hospital
Stockholm, Region Stockholm, 17176
About this study
Official title: Predictive Value of the PBS-score - A Prospective Observational Cohort Study Evaluating Recurrence of Idiopathic Clubfoot and Need for Additional Treatment
Evaluate the predictive value of the PBS-score in predicting recurrence of idiopathic clubfoot, measured as need for additional treatment.
Read the detailed description
Using a consecutive inclusion, we aim to include 60 children and register data proposed by the COS for PEVA. All items of the PBS-score are video-documented, and dynamic foot pressure during walking is recorded during a clinical visit at the Motion Analysis Lab at Karolinska University Hospital. Children and caregivers will complete Roye's score, a disease-specific PROM and Oxford Foot and Ankle Questionaire-child (OxFAQc). For children aged 6 years or older, standing radiographic imaging of both feet will be performed. Inclusion criteria include: age 4-8 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English. Included children will be followed prospectively during five years through clinical visits and medical records, where need for additional treatment (casting, braces and/or surgery) is the primary endpoint.
- Conditions
- Clubfoot
- Being tested
- Systematic screening
- Keywords
- PBS-score, Oxford Foot and Ankle Questionaire-child, Roye's score, Pedobarography
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic screeningOther
Also called PBS-score, video evaluation, PROM, dynamic foot pressure
Included children will be followed prospectively during five years through clinical visits and medical records, where need for additional treatment (casting, braces and/or surgery) is the primary endpoint.
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for further treatment
total number of casting, type of braces and/or choice of orthopedic surgery
Measured: 5 years
Secondary outcomes (2)
Patient reported outcome measures (PROM)
Children and caregivers will complete Roye's score, a disease-specific PROM. The Roye´s score consists of 10 items designed to measure treatment outcomes regarding overall satisfaction, appearance, pain, and physical limitations.
Measured: 5 years
Patient reported outcome measures - The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) is a child - or parent (proxy)
Children and caregivers will complete The Oxford Foot and Ankle Questionaire-child (OxFAQc) and a proxy for caregivers measure subjective well-being in children affected by foot and ankle pain and function. The OxFAQc has 15 items. The response options to each item are on a 5-point scale rated from never (4), rarely (3), sometimes (2), very often (1) to always (0), where the number in brackets represents the value that should be applied by the scorer to each response. Domain scores are calculated as the total of the scale item scores divided by the maximum for each domain, physical 24, and school \& play and emotional 16). Domain scores can be transformed to a percentage scale (0-100) to aid interpretation. A higher score for a domain represents better functioning.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start10 Jan 2023
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 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.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eva Weidenhielm-Brostrom, Region Stockholm
- Investigators
- Eva W Broström, Professor, Principal investigator, Astrid Lindgren Children´s Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050746
- Sponsor's protocol ID
- k2022-10476-01
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2023
- Last updated
- 15 Sep 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the PBS-score - A Prospective Observational Cohort Study Evaluating Recurrence of Idiopathic Clubfoot and Need for Additional Treatment
- ClinicalTrials.gov ID
- NCT06050746
- Acronym / sponsor ID
- k2022-10476-01
- Conditions
- Clubfoot
- Keywords
- PBS-score, Oxford Foot and Ankle Questionaire-child, Roye's score, Pedobarography
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 22 Sep 2023 (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.
Evaluate the predictive value of the PBS-score in predicting recurrence of idiopathic clubfoot, measured as need for additional treatment.
Detailed description
Using a consecutive inclusion, we aim to include 60 children and register data proposed by the COS for PEVA. All items of the PBS-score are video-documented, and dynamic foot pressure during walking is recorded during a clinical visit at the Motion Analysis Lab at Karolinska University Hospital. Children and caregivers will complete Roye's score, a disease-specific PROM and Oxford Foot and Ankle Questionaire-child (OxFAQc). For children aged 6 years or older, standing radiographic imaging of both feet will be performed. Inclusion criteria include: age 4-8 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English. Included children will be followed prospectively during five years through clinical visits and medical records, where need for additional treatment (casting, braces and/or surgery) is the primary endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with idopatic clubfoot treated at Astrdi lindgren Children´s Hospital
Key inclusion criteria (1 listed)
- age 4-10 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English.
Key exclusion criteria (1 listed)
- Syndromic clubfoot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic screeningAlso: PBS-score, video evaluation, PROM, dynamic foot pressureIncluded children will be followed prospectively during five years through clinical visits and medical records, where need for additional treatment (casting, braces and/or surgery) is the primary endpoint. | Other | – |
Primary outcome
Need for further treatment
Time frame: 5 years
total number of casting, type of braces and/or choice of orthopedic surgery
2 secondary outcomes
Patient reported outcome measures (PROM)
Time frame: 5 years
Patient reported outcome measures - The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) is a child - or parent (proxy)
Time frame: 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 15 Sep 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. This study is not recruiting at the moment.
Eva W Broström, Professor principal investigator
Astrid Lindgren Children´s Hospital
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, run by Region Stockholm at 1 site in Sweden.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 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 Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for further treatment (time frame: 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 15 Sep 2025.