Status:
COMPLETED
Orthotics for Treatment of Symptomatic Flat Feet in Children
Lead Sponsor:
University of York
Collaborating Sponsors:
University of Leeds
University of Salford
Conditions:
Pes Planus
Eligibility:
All Genders
6-14 years
Phase:
NA
Brief Summary
Update 13.12.2021 To mitigate the effects the COVID-19 pandemic, and due to difficulties in sites setting up the custom orthoses arm of the protocol an amendment was approved to change the design of t...
Detailed Description
The aim of the study is to undertake a large, pragmatic, multi-armed, randomised controlled trial to assess the clinical and cost-effectiveness of prefabricated orthoses in addition to exercises and a...
Eligibility Criteria
Inclusion
- OSTRICH main trial inclusion criteria:
- Potential participants will be included in the trial if they fulfil all of the following criteria:
- Are aged between six and 14 years, inclusive
- Have one or both symptomatic pes planus\*
- The child and/or parent/legal guardian is able to speak, write and understand English
- The parent/legal guardian is able to give informed consent \*Symptomatic pes planus is described as the manifestation of foot and lower limb symptoms, secondary to altered foot alignment (reduced medial longitudinal arch, everted rearfoot and abducted forefoot). The diagnosis will be made pragmatically, by treating clinicians in line with current practice
- OSTRICH main trial exclusion criteria:
- Potential participants will be excluded from the study if they fulfil any of the following criteria:
- Have a history of major trauma or fracture of the lower leg (below knee)
- Have pes planus secondary to any systematic condition/syndrome\*\* /malignancy
- Have a history of foot and/or ankle surgery
- Require an ankle-foot orthoses or other lower limb device or have received treatment previously for their flat feet
- This does not exclude children with hypermobility spectrum disorder (HSD) where the manifestation is non-syndromic and isolated (L-HSD), peripheral (P-HSD) or generalised hypermobility (G-HSD)(14).
- OSTRICH signposting to multimedia trial information SWAT: inclusion criteria any potential participant identified as eligible to be sent trial information from a site taking part in the SWAT, will be eligible for the study.
- OSTRICH birthday card SWAT Inclusion criteria: All participants recruited into the host trial will be eligible to take part in this SWAT. Exclusion criteria: Any participant who has withdrawn from the main OSTRICH study or is not due a follow up questionnaire will be excluded.
Exclusion
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT04104555
Start Date
April 21 2022
End Date
August 31 2023
Last Update
November 29 2023
Active Locations (16)
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1
East Cheshire NHS Trust
Macclesfield, Cheshire, United Kingdom, SK10 3BL
2
Birmingham Community Healthcare NHS Foundation Trust
Birmingham, United Kingdom, B7 4BN
3
Bolton NHS Foundation Trust
Bolton, United Kingdom, BL4 OJR
4
Cardiff and Vale University Local Health Board
Cardiff, United Kingdom, CF14 4XW