Foot orthoses for children with flat feet (the OSTRICH trial)

Not Applicable

Completed

• Conditions: Pes planus (flat feet); Musculoskeletal Diseases; Pes planus

• Registration Number: ISRCTN14602568
• Lead Sponsor: niversity of York

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-18
• Study Completion: 2023-08-31
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1. Are aged between 6 and 14 years, inclusive
2. Have one or both symptomatic pes planus*
3. The child and/or parent/legal guardian is able to speak, write and understand English
4. 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.

Eligibility for the Birthday card SWAT
All participants recruited into the host trial will be eligible to take part in this SWAT.

Exclusion Criteria

1. Have a history of major trauma or fracture to lower leg (below knee)
2. Have pes planus secondary to any systematic condition/syndrome**/malignancy
3. Have a history of foot and/or ankle surgery
4. Require an ankle-foot orthosis or other lower limb device
5. Have previously received treatment for pes planus

** 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)

Eligibility for the Birthday card SWAT
Participants will be excluded from this study if they have asked to be withdrawn from the main OSTRICH study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified