Condition category
Musculoskeletal Diseases
Date applied
27/03/2020
Date assigned
18/05/2020
Last edited
03/09/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
As a child grows the shape of their foot changes, and most develop an arch in their foot. This doesn't always happen though, and sometimes the arch does not form, or it might be flat against the ground. When this happens, it is known as having flat feet. Unfortunately, some of these children get pain in their feet, legs or back because of their 'flat feet'. At the moment the researchers are not sure which is the best treatment for them, so the researchers are going to conduct a study to compare three of the most common treatments that are used today. Two of the treatments the researchers are going to test are different types of insoles that are put inside the child's shoe. The third treatment is some exercises which the researchers will give the young person along with advice on things like which type of shoes may help.

Who can participate?
Patients aged between 6 and 14 years and have one or both symptomatic pes planus.

What does the study involve?
If a young person and their parent, or guardian, decide that they want to take part in the study, they will receive their treatment as part of their normal NHS care. The researchers will ask 1085 children aged between 6 and 14 years to take part in the study. 423 children will receive exercise, advice, and insoles that are custom made for them; 423 will receive insoles that are the correct size but not custom made (i.e. off the shelf); and 239 will receive the exercise programme and advice without insoles. The researchers will ask for their help for 12 months. During this time, the researchers will track their progress by sending them three questionnaires in the post to fill in and the researchers will send them some text messages, to find out how painful their feet are in the first few months. The researchers also want to learn more about the problems that flat feet have caused, and children's experiences of the treatments delivered as part of the trial. The researchers will explore this through in-depth conversations with children and their parents or guardian. Once the researchers have finished the trial, the researchers 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.

What are the possible benefits and risks of participating?
There may not be many direct benefits of participating in this trial as the treatments are provided in routine care. However, if enough people take part in the study, the results will provide valuable information about the best way to manage children with painful flat feet in the future. Equally, we do not think that taking part in the trial poses any additional risks for participants as the treatments are used in routine care. Taking part in the study will involve some of your time to complete questionnaires, texts and possibly an extra visit to the clinic.

Where is the study run from?
York Trials Centre, University of York (UK)

When is the study starting and how long is it expected to run for?
September 2020 to November 2022

Who is funding the study?
NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC)

Who is the main contact?
Sarah Cockayne, sarah.cockayne@york.ac.uk
Dr Mike Backhouse, mike.backhouse@york.ac.uk

Trial website

https://www.york.ac.uk/healthsciences/research/trials/research/trials/ostrich

Contact information

Type

Scientific

Primary contact

Mrs Sarah Cockayne

ORCID ID

http://orcid.org/0000-0002-1288-5497

Contact details

University of York
York Trials Unit
Dpt Health Sciences
ARRC Building
York
YO10 5DD
United Kingdom
+44 (0)1904321736
sarah.cockayne@york.ac.uk

Type

Scientific

Additional contact

Dr Mike Backhouse

ORCID ID

http://orcid.org/0000-0003-0056-8467

Contact details

York Trials Unit
University of York
York
YO10 5DD
United Kingdom
+44 (0)1904 321078
mike.backhouse@york.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

NCT04104555

Protocol/serial number

CPMS 44513, IRAS 282832

Study information

Scientific title

Orthotics for Treatment of Symptomatic Flat Feet in Children - The OSTRICH study

Acronym

OSTRICH

Study hypothesis

There is a difference in the clinical effectiveness of custom-made and prefabricated orthoses in addition to advice and exercise alone on the physical functioning of children with symptomatic pes planus.

Ethics approval

Approved 06/08/2020, North East York Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8091; york.rec@hra.nhs.uk), ref: 20/NE/0173

Study design

Interventional randomized controlled trial including a qualitative study within a trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Pes planus (flat foot)

Intervention

Participants will be allocated to one of three groups:
1. A package consisting of an exercise programme and advice covering topics such as typical arch development in children, coping strategies, and footwear advice
2. The exercise and advice package plus a pair of prefabricated, off-the-shelf orthoses (i.e. insoles which are mass produced to a generic shape but can be adapted by a clinician)
3. The exercise and advice package plus a pair of custom-made foot orthoses, where the shape of the insole is made for a specific person based on a 3D impression or scan of the patient’s foot

The participant will be informed which group they have been allocated to at their first trial appointment. Participants will be asked to wear their orthoses every day in their shoes and to do their exercises. Participants in group 1 and 2 will on the whole, need one clinic appointment, but those in group 3, may need a total of 2 or 3 appointments. Blinding of participants to the treatment allocation is not possible.

Measures will be collected at baseline, weeks 1-12, and at three, six and 12 months after a participant is enrolled into the study. The measures are all self-reported by either the participant or their parent/legal guardian.

Birthday card study
In the birthday card SWAT, the researchers will evaluate whether sending a participant a birthday card increases the number of questionnaires they return to the study team. Participants will be allocated to one of three groups; birthday card, birthday card informed by nudge theory to encourage completion of questionnaires or no birthday card. The birthday card will be developed with the help of a patient and public involvement group.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Physical domain subscale of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C); Timepoint(s): Over the 12-month follow up period

Secondary outcome measures

1. The well-being of children measured using the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) other domains at three, six and 12 months
2. Quality of life measured using the CHU9D at 3, 6 and 12 months
3. Mobility, ability to look after themselves, doing their usual activities, whether they have any pain or discomfort and if they feel worried, sad or unhappy measured using the EQ-5D-Y at 3, 6 and 12 months
4. Foot pain scores reported by parents once a week, for a total of 12 weeks on a scale of 0 to 9
4.1. Participants foot pain, over the past week, for both their left and right foot using the Wong-Baker FACES pain rating scale at 3, 6 and 12 months
5. Complications and adverse events. Information about any problems participants have had whilst either wearing the insoles or doing the exercises will be recorded as they happen. Expected complications such as aches and pains, blisters, ulcers, skin irritation and falling
will be recorded in the follow-up questionnaires sent to participants at 3, 6 and 12 months
6. Health care use by self-report at 3, 6 and 12 months
7. Qualitative interview of children and parents to find out about their experiences of having flat feet, at the start and the end of the study
8. SWAT outcome: number of questionnaires returned throughout the study period

Overall trial start date

01/06/2019

Overall trial end date

30/11/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 1055; UK Sample Size: 1055

Participant 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.

Recruitment start date

01/11/2020

Recruitment end date

30/08/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Community Healthcare NHS Foundation Trust
3, Priestley Wharf Holt Street Birmingham Science Park Aston
Birmingham
B7 4BN
United Kingdom

Trial participating centre

The Royal Bolton Hospital
Bolton NHS Foundation Trust Minerva Road Farnworth
Bolton
BL4 0JR
United Kingdom

Trial participating centre

Cardiff and Vale University Health Board
Cardiff and Vale UHB Headquarters University Hospital of Wales (UHW) Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Macclesfield District General Hospital
East Cheshire NHS Trust Victoria Road
Macclesfield
SK10 3BL
United Kingdom

Trial participating centre

Harrogate District Hospital
Harrogate and District NHS Foundation Trust Lancaster Park Road
Harrogate
HG2 7SX
United Kingdom

Trial participating centre

Maidstone Hospital
Maidstone and Tunbridge Wells NHS Trust Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom

Trial participating centre

Lancashire Care NHS Foundation Trust
Sceptre Point Sceptre Way Bamber Bridge
Preston
PR5 6AW
United Kingdom

Trial participating centre

Royal Preston Hospital
Sharoe Green Lane North Fulwood
Preston
PR2 9HT
United Kingdom

Trial participating centre

Norfolk & Norwich University Hospital
Norfolk and Norwich University Hospitals NHS Foundation Trust Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

University Hospital of Hartlepool
North Tees and Hartlepool NHS Foundation Trust Holdforth Road
Hartlepool
TS24 9AH
United Kingdom

Trial participating centre

Royal Stoke University Hospital
University Hospitals of North Midlands NHS Trust Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Trial participating centre

Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
S10 2TH
United Kingdom

Trial participating centre

Brighton General Hospital
Sussex Community NHS Foundation Trust Eastern Road
Brighton
BN2 3EW
United Kingdom

Trial participating centre

St James's University Hospital
Leeds Teaching Hospitals NHS Trust Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Gobowen
Oswestry
SY10 7AG
United Kingdom

Trial participating centre

The Royal Orthopaedic Hospital Nhs Foundation Trust
The Woodlands Bristol Road South Northfield
Birmingham
B31 2AP
United Kingdom

Trial participating centre

Torbay Hospital
Torbay and South Devon Nhs Foundation Trust Newton Road
Torquay
TQ2 7AA
United Kingdom

Trial participating centre

County Hospital
Wye Valley Nhs Trust Union Walk
Hereford
HE1 2ER
United Kingdom

Trial participating centre

Diana Princess of Wales Hospital
Northern Lincolnshire and Goole Nhs Foundation Trust Scartho Road
Grimsby
DN33 2BA
United Kingdom

Trial participating centre

Leeds Community Healthcare Nhs Trust
Stockdale House 8 Victoria Road
Leeds
LS6 1PF
United Kingdom

Trial participating centre

Walsgrave General Hospital
University Hospitals Coventry and Warwickshire Nhs Trust Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Alder Hey Hospital
Eaton Road West Derby
Liverpool
L12 2AP
United Kingdom

Sponsor information

Organisation

University of York

Sponsor details

Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 328693
michael.barber@york.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR127510

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

unknown

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Findings from this trial will be disseminated at appropriate professional and scientific conferences and published in appropriate journals. Findings will also be disseminated to patient groups and the wider public.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

30/11/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/09/2020: Ethics approval details added. The recruitment start date was changed from 01/09/2020 to 01/11/2020. 30/03/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).