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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06050746
Other study ID # k2022-10476-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 12, 2023
Est. completion date March 31, 2024

Study information

Verified date September 2023
Source Region Stockholm
Contact Eva W Broström, Professor
Phone +4670021670
Email eva.brostrom@ki.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluate the predictive value of the PBS-score in predicting recurrence of idiopathic clubfoot, measured as need for additional treatment.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Syndromic clubfoot

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Systematic screening
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.

Locations

Country Name City State
Sweden Astrid Lindgren Children´s Hospital Stockholm Region Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Need for further treatment total number of casting, type of braces and/or choice of orthopedic surgery 5 years
Secondary 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. 5 years
Secondary 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. 5 years
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