ClubfootPEVANCT06033638
Video Documented PBS-Score in Children With Clubfoot
An observational study of Clubfoot and PBS, run by Region Stockholm at 1 site in Sweden.
Trial summary
Evaluate agreement and inter-rater reliability of PBS-score assessments based on video documented material. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- What is being tested?
- Score assessment
- How many people
- 55 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2023to 18 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children born with clubfoot
Who may be able to join
- Clubfoot
Who cannot join
- -
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: Agreement and Inter-rater Reliability of Video Documented PBS-Score - An International Cross-sectional Multicenter Study
Evaluate agreement and inter-rater reliability of PBS-score assessments based on video documented material.
Read the detailed description
120 children with idiopathic clubfoot will be included from four different countries 30 patients from each participating center. Inclusion criteria include: age 4-14 years, diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto. All items of the PBS-score will be documented using video recordings. Six to eight senior orthopedic surgeons will score a total of 90 children each, not the children from their center of employment, according to the PBS-score based on videos. Collaborating centers include Karolinska University Hospital, Sweden, Hospital Pequeno Príncipe, Brazil, and Hayatabad Medical Complex, Orthopaedic Unit, Peshawar, Pakistan.
- Being tested
- Score assessment
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Score assessmentOther
Also called PBS-score, video evaluation, PROM
PBS Score
What is being measured
The primary outcome is the main question the study is designed to answer.
PBS Score agreement and inter-rater reliability
PBS Score is a tool to grade the severity of clubfoot recurrence in the walking child, and was proposed to serve as an instrument to guide treatment. The sum of all points for all signs is scored between 7 and 18.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start10 Jan 2023
- Primary completion28 Dec 2023
- Study completion18 Jun 2024
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
- 55 participants (actual)
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
- NCT06033638
- Sponsor's protocol ID
- K 2022-10475
- Acronym
- PEVA
- Status last verified
- Sep 2025
- First submitted
- 10 May 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
- Agreement and Inter-rater Reliability of Video Documented PBS-Score - An International Cross-sectional Multicenter Study
- ClinicalTrials.gov ID
- NCT06033638
- Acronym / sponsor ID
- PEVA / K 2022-10475
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 13 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 agreement and inter-rater reliability of PBS-score assessments based on video documented material.
Detailed description
120 children with idiopathic clubfoot will be included from four different countries 30 patients from each participating center. Inclusion criteria include: age 4-14 years, diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto. All items of the PBS-score will be documented using video recordings. Six to eight senior orthopedic surgeons will score a total of 90 children each, not the children from their center of employment, according to the PBS-score based on videos. Collaborating centers include Karolinska University Hospital, Sweden, Hospital Pequeno Príncipe, Brazil, and Hayatabad Medical Complex, Orthopaedic Unit, Peshawar, Pakistan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children born with clubfoot
Key inclusion criteria (1 listed)
- Clubfoot
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Score assessmentAlso: PBS-score, video evaluation, PROMPBS Score | Other | – |
Primary outcome
PBS Score agreement and inter-rater reliability
Time frame: 1 year
PBS Score is a tool to grade the severity of clubfoot recurrence in the walking child, and was proposed to serve as an instrument to guide treatment. The sum of all points for all signs is scored between 7 and 18.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and PBS, 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PBS Score agreement and inter-rater reliability (time frame: 1 year). 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.