Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score

NCT ID: NCT06050564

Last Updated: 2025-09-15

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

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-10

Study Completion Date

2024-06-18

Brief Summary

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Determine the relationship between the PBS-score and treatment recommendations provided by senior pediatric orthopedic surgeons.

Detailed Description

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In conjunction with the assessments of video documented PBS-score items (described in Study I), treatment recommendations from six to eight experienced pediatric orthopedic surgeons from four different countries will be collected. Their recommendations will be based on the included items of the PBS-score, and patient history including age of the child, Pirani score, initial treatment (need for tenotomy), and reported compliance to orthotic use.

Conditions

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Clubfoot

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Treatment recommendations will be based on video documented PBS-Score

Therapeutic recommendations from orthopedic surgeons, will be summarized and described

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* syndromic clubfoot
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eva Weidenhielm-Brostrom

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva W Broström, Professor

Role: PRINCIPAL_INVESTIGATOR

Astrid Lindgren Children´s Hospital

Locations

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Astrid Lindgren Children´s Hospital

Stockholm, Region Stockholm, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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K2022-10587

Identifier Type: -

Identifier Source: org_study_id

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