Orthotics for Treatment of Symptomatic Flat Feet in Children
OSTRICH
1 other identifier
interventional
134
1 country
16
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 the study from a 3 to a 2 arm trial. The amendment drops the custom orthoses arm and was implemented prior to the start of recruitment. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2019
CompletedFirst Posted
Study publicly available on registry
September 26, 2019
CompletedStudy Start
First participant enrolled
April 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedNovember 29, 2023
November 1, 2023
1.4 years
September 19, 2019
November 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical domain subscale of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) over the 12 month follow-up period.
The OxAFQ-C is a self-report health status measure questionnaire for child patients (aged 5-14) affected by foot and ankle conditions that are considered important to children. There are three domains, whose domain scores are reported separately (ie there is no total score). For the primary outcome however, we will just use the physical domain subscale. There are 6 items on the 'Physical' domain. 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 to each response. The total 'physical domain score' is divided by the maximum for the domain ie 24. This score can then be transformed to a percentage scale (0-100) to aid interpretation. A higher score for a domain represents better functioning. This will be rated by the child (participant) and their parent/legal guardian using a proxy version.
For the primary comparison the physical domain subscale will be compared between the groups using a linear covariance pattern mixed model to estimate the effect over the whole 12 month followup, incorporating data from all available time points
Secondary Outcomes (8)
The 'School and Play' domain of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
Collected at baseline, 3,6 and 12 months post randomisation
The 'Emotional' subscale of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
Collected at baseline, 3,6 and 12 months post randomisation
Footwear item of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
Collected at baseline, 3, 6 and 12 months post randomisation
EuroQoL-Five Dimension Youth
Collected at baseline, 3,6 and 12 months post randomisation
Child Health Utility 9D (CHU9D)
Collected at baseline, 3,6 and 12 months post randomisation
- +3 more secondary outcomes
Other Outcomes (9)
Proportion of participants who go on to be randomised to the OSTRICH trial.
Post randomisation
Retention to main OSTRICH trial
3, 6 and 12 months post randomisation
Response rate to the participant follow-up questionnaire at the first time point following receipt of the birthday card
Next followup either , 3, 6 or 12 months post randomisation
- +6 more other outcomes
Study Arms (6)
Usual supportive care - exercises and footwear advice
ACTIVE COMPARATOROSTRICH 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.
Prefabricated, off-the-shelf orthoses
EXPERIMENTALOSTRICH 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.
Signposting to multimedia
EXPERIMENTALOSTRICH '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.
Standard written information only
NO INTERVENTIONOSTRICH 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.
Birthday card
EXPERIMENTALOSTRICH 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.
No birthday card
NO INTERVENTIONOSTRICH Birthday card study within a trial (SWAT) Participants will not be sent a birthday card during the trial.
Interventions
Signposting to multimedia information in the patient information sheet which is sent to participants in the post as part of the OSTRICH recruitment pack.
Active comparator
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Yorklead
- University of Leedscollaborator
- University of Salfordcollaborator
- University of Oxfordcollaborator
- King's College Londoncollaborator
- University of Warwickcollaborator
Study Sites (16)
East Cheshire NHS Trust
Macclesfield, Cheshire, SK10 3BL, United Kingdom
Birmingham Community Healthcare NHS Foundation Trust
Birmingham, B7 4BN, United Kingdom
Bolton NHS Foundation Trust
Bolton, BL4 OJR, United Kingdom
Cardiff and Vale University Local Health Board
Cardiff, CF14 4XW, United Kingdom
Medway Community Healthcare
Gillingham, ME8 0PZ, United Kingdom
North Lincolnshire & Goole NHS Foundation Trust
Goole, United Kingdom
Harrogate and District Foundation Trust
Harrogate, HG2 7SX, United Kingdom
Leeds Community Healthcare NHS Trust
Leeds, LS6 1PF, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
Kent Community Health NHS Foundation Trust
Maidstone, ME16 9NT, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW, United Kingdom
Lancashire & South Cumbria Nhs Foundation Trust
Preston, PR5 6AW, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD, United Kingdom
Solent NHS Trust
Southampton, United Kingdom
Royal National Orthopaedic Hospital NHS Trust
Stanmore, HA7 4LP, United Kingdom
Walsall Healthcare NHS Trust
Walsall, United Kingdom
Related Publications (2)
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.
PMID: 35080267DERIVEDEvans 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.
PMID: 35029841DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Torgerson, PhD
University of York
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Fellow
Study Record Dates
First Submitted
September 19, 2019
First Posted
September 26, 2019
Study Start
April 21, 2022
Primary Completion
August 31, 2023
Study Completion
August 31, 2023
Last Updated
November 29, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
Requests for OSTRICH study data may be submitted to the Chief Investigator once the results of the study have been published. Requests will be dealt with on a case by case basis and in accordance with the University of York, Department of Health Sciences, York Trials Unit's Standard Operating Procedures.