Orthotics for Treatment of Symptomatic Flat Feet in Children
NCT ID: NCT04104555
Last Updated: 2023-11-29
Study Results
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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COMPLETED
NA
134 participants
INTERVENTIONAL
2022-04-21
2023-08-31
Brief Summary
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As a child grows the shape of their foot changes and most develop an arch in their foot. For some, however, the arch does not fully form or it might be flat against the ground. This is known as having flat feet and it can cause pain in the feet, legs, or back. At the moment, we are not sure what the best treatment for flat feet is, so the purpose of this research is to conduct a trial to compare two of the most common treatments. The first is exercise and advice about things like which types of shoes might help. The second of the treatment is a type of insole, which is put inside the shoe.
Participants will receive their treatment as part of their normal National Health System care. We would like 478 children and young people aged between 6 and 14 years old to take part in the study. Everyone will receive advice about the type of shoes to wear, ankle exercises and things to look out for when children have painful flat feet. In addition to this, half of the participants will receive a pre-made insole that is the right size. We will ask for their help for 12 months. During this time, we will track their progress by sending them 3 questionnaires in the post to fill in and weekly text messages to find out how painful their feet are during the first few months. We also want to learn more about the problems that flat feet cause, and children's experiences of the treatments delivered as part of this clinical trial. We will explore this through in-depth conversations with children and their parent(s) or the person who looks after them. Once we have finished the trial, we will work with the people who took part in the trial, and clinicians, to make sure that our results can be used by as many people as possible.
We will run 3 additional studies. The first will find out if having information about the study in the form of a video in addition to information in a paper booklet will increase recruitment rates. The second will find out if sending participants a birthday card will increase the response rates to postal questionnaires. The third study will take a 3D impression of the participant's foot and see if it changes over the course of the study.
Detailed Description
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In addition to the main OSTRICH study we will undertake two additional trial methodological Studies within a Trial (SWAT) and a sub-study.
The multimedia trial information SWAT: This SWAT will evaluate the effectiveness of including signposting to multimedia trial information in the patient information sheet, which is sent to participants in their recruitment pack.
The birthday card SWAT: This SWAT will evaluate the effectiveness of sending a birthday card to participants on response rates to postal questionnaires.
Foot scan sub-study: This embedded observational sub-study will assess the capability of a 3D scanning approach to identify and stratify severity of pes planus and to assess change in foot shape over the duration of the trial. We will investigate the associations between aspects of foot shape and score on the physical domain scale of the OxAFQ-C.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usual supportive care - exercises and footwear advice
OSTRICH main trial:
Participants will be offered an exercise programme and advice regarding footwear. The treating clinician will be able to prescribe appropriate exercises from a menu of exercises.
Usual supportive care - exercises and footwear advice (the comparator)
Active comparator
Prefabricated, off-the-shelf orthoses
OSTRICH main trial:
A pair of prefabricated, off-the-shelf orthoses (i.e. mass produced to a generic shape but can be adapted by a clinician) plus an exercise programme and advice regarding footwear. The treating clinician will be able to prescribe appropriate exercises from a menu of exercises.
Prefabricated orthoses
Prefabricated insole
Signposting to multimedia
OSTRICH 'signposting to multimedia' Study within a trial (SWAT) Participants will be given signposting information to the multimedia trial information resources in the participant information sheet which is included in the OSTRICH recruitment pack.
Signposting to multimedia
Signposting to multimedia information in the patient information sheet which is sent to participants in the post as part of the OSTRICH recruitment pack.
Standard written information only
OSTRICH signposting to multimedia' Study within a trial (SWAT) Participants will receive the standard written information sheet only. This will not include signposting to the multimedia trial information resources, in the OSTRICH recruitment pack.
No interventions assigned to this group
Birthday card
OSTRICH Birthday card study within a trial (SWAT) Participants will be sent a birthday card on or shortly before their birthday from the OSTRICH study team to encourage completion of questionnaires.
Birthday card
Birthday card sent to participants in the post
No birthday card
OSTRICH Birthday card study within a trial (SWAT) Participants will not be sent a birthday card during the trial.
No interventions assigned to this group
Interventions
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Birthday card
Birthday card sent to participants in the post
Prefabricated orthoses
Prefabricated insole
Signposting to multimedia
Signposting to multimedia information in the patient information sheet which is sent to participants in the post as part of the OSTRICH recruitment pack.
Usual supportive care - exercises and footwear advice (the comparator)
Active comparator
Eligibility Criteria
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Inclusion 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
Exclusion 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).
6 Years
14 Years
ALL
No
Sponsors
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University of Leeds
OTHER
University of Salford
OTHER
University of Oxford
OTHER
King's College London
OTHER
University of Warwick
OTHER
University of York
OTHER
Responsible Party
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Sarah Cockayne
Research Fellow
Principal Investigators
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David Torgerson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of York
Locations
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East Cheshire NHS Trust
Macclesfield, Cheshire, United Kingdom
Birmingham Community Healthcare NHS Foundation Trust
Birmingham, , United Kingdom
Bolton NHS Foundation Trust
Bolton, , United Kingdom
Cardiff and Vale University Local Health Board
Cardiff, , United Kingdom
Medway Community Healthcare
Gillingham, , United Kingdom
North Lincolnshire & Goole NHS Foundation Trust
Goole, , United Kingdom
Harrogate and District Foundation Trust
Harrogate, , United Kingdom
Leeds Community Healthcare NHS Trust
Leeds, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Kent Community Health NHS Foundation Trust
Maidstone, , United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
Lancashire & South Cumbria Nhs Foundation Trust
Preston, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Solent NHS Trust
Southampton, , United Kingdom
Royal National Orthopaedic Hospital NHS Trust
Stanmore, , United Kingdom
Walsall Healthcare NHS Trust
Walsall, , United Kingdom
Countries
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References
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Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.
Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.
Other Identifiers
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265719
Identifier Type: -
Identifier Source: org_study_id