Foot orthoses for children with flat feet (the OSTRICH trial)
| ISRCTN | ISRCTN14602568 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14602568 |
| IRAS number | 282832 |
| ClinicalTrials.gov number | NCT04104555 |
| Secondary identifying numbers | CPMS 44513, IRAS 282832 |
- Submission date
- 27/03/2020
- Registration date
- 18/05/2020
- Last edited
- 09/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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 two of the most common treatments that are used today. The first is exercise and advice about things like which types of shoes might help. The second is a type of insole, which is put inside the shoe.
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 478 children aged between 6 and 14 years to take part in the study. 239 children 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 August 2023
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
Contact information
Scientific
University of York
York Trials Unit
Dpt Health Sciences
ARRC Building
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0002-1288-5497 |
|---|---|
| Phone | +44 (0)1904321736 |
| sarah.cockayne@york.ac.uk |
Study information
| Study design | Interventional randomized controlled trial including a qualitative study within a trial and economic evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Orthotics for Treatment of Symptomatic Flat Feet in Children - The OSTRICH study |
| Study acronym | OSTRICH |
| Study hypothesis | Current study hypothesis as of 19/11/2021: There is a difference in the clinical effectiveness of prefabricated orthoses in addition to advice and exercise alone on the physical functioning of children with symptomatic pes planus. Previous 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(s) | 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 |
| Condition | Pes planus (flat feet) |
| Intervention | Current intervention as of 27/02/2023: To mitigate the effect of the COVID-19 pandemic and as many sites have been unable to deliver the 3-arm trial design and struggled with the provision of custom insoles the funder and ethics approved a change in design to the study and agreed the custom insole arm of the trial could be dropped. Participants will be allocated in a 1:1 ratio to one of two groups in the trial: 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) 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 will, overall, need one clinic appointment, but those in group 2, may need a total of 2 or 3 appointments. Blinding 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 on 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 two groups: a birthday card, or no birthday card. The birthday card will be developed with the help of a patient and public involvement group. Sites will have the option to undertake an embedded observational sub-study that explores the variation in foot shape using a 3D scanning approach. Foam impression boxes will be used to capture the 3D shape of the participant’s feet. These will be scanned using a 3D scanner to enable the construction of the computer model. Participants will complete a second impression 12 months later. This will allow us to explore i) variation in foot shape; ii) whether foot shape influences response to therapy within the main trial iii) how a child's foot changes over 12 months and whether orthoses influence this change. Previous intervention as of 19/11/2021 to 27/02/2023: In order to mitigate the effect of the COVID-19 pandemic and as many sites have been unable to deliver the 3 arm trial design and struggled with the provision of custom insoles the funder and ethics approved a change in design to the study and agreed the custom insole arm of the trial could be dropped. Participants will be allocated in a 1:1 ratio to one of two groups in the trial: 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) 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 will, on the whole, need one clinic appointment, but those in group 2, 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. Previous 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 |
| 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 3, 6 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 study start date | 01/06/2019 |
| Overall study end date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 478 |
| Total final enrolment | 134 |
| 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 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 | 21/04/2022 |
| Recruitment end date | 26/07/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Holt Street
Birmingham Science Park
Aston
Birmingham
B7 4BN
United Kingdom
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
University Hospital of Wales (UHW)
Heath Park
Cardiff
CF14 4XW
United Kingdom
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Lancaster Park Road
Harrogate
HG2 7SX
United Kingdom
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Scartho Road
Grimsby
DN33 2BA
United Kingdom
8 Victoria Road
Leeds
LS6 1PF
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Stanmore
HA7 4LP
United Kingdom
The Oast
Hermitage Lane
Maidstone
ME16 9NT
United Kingdom
Highpoint Venue
Bursledon Road
Southampton
SO19 8BR
United Kingdom
Moat Road
Walsall
WS2 9PS
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Gillingham Business Park
Gillingham
ME8 0PZ
United Kingdom
Treliske
Truro
TR1 3LJ
United Kingdom
London
SW17 0QT
United Kingdom
Sponsor information
University/education
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)1904 328693 |
|---|---|
| michael.barber@york.ac.uk | |
| Website | http://www.york.ac.uk/ |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/09/2024: The study record is up to date.
11/01/2024: The study participating centres Royal Preston Hospital and Sheffield Children's NHS Foundation Trust were removed.
01/09/2023: A contact was removed.
08/08/2023: The final enrolment number has been added.
26/07/2023: The following changes were made to the trial record:
1. The study setting 'Other' was added.
2. The recruitment end date was changed from 30/09/2023 to 26/07/2023.
3. The overall end date was changed from 31/03/2024 to 31/08/2023.
4. The study participating centres Royal Cornwall Hospitals NHS Trust, St George's Hospital NHS Foundation Trust were added.
13/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/03/2023 to 30/09/2023.
2. The overall end date was changed from 30/09/2023 to 31/03/2024.
3. The intention to publish date was changed from 14/10/2024 to 31/03/2025.
4. The plain English summary was updated to reflect these changes.
27/02/2023: The following changes were made to the trial record:
1. The overall trial end date has been changed from 31/03/2023 to 30/09/2023 and the plain English summary has been updated to reflect this change.
2. The interventions were changed.
3. The trial participating centres were updated to remove Alder Hey Hospital.
04/01/2023: The recruitment end date has been changed from 31/12/2022 to 30/03/2023.
04/08/2022: The recruitment end date has been changed from 01/10/2022 to 31/12/2022.
02/08/2022: The recruitment end date has been changed from 31/08/2022 to 01/10/2022.
14/07/2022: The trial participating centres were updated to remove Maidstone and Tunbridge Wells NHS Trust, Norfolk & Norwich University Hospital, North Tees and Hartlepool NHS Foundation Trust, University Hospitals of North Midlands NHS Trust, Sussex Community NHS Foundation Trust, The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, The Royal Orthopaedic Hospital NHS Foundation Trust, Torbay and South Devon Nhs Foundation Trust, and Wye Valley NHS Trust. South Tees Hospitals NHS Foundation Trust and Medway Community Healthcare were added.
28/06/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 30/03/2022 to 21/04/2022.
2. The recruitment end date was changed from 31/07/2022 to 31/08/2022.
15/06/2022: The recruitment end date was changed from 30/06/2022 to 31/07/2022.
08/03/2022: The following changes have been made:
1. The recruitment start date has been changed from 07/03/2022 to 30/03/2022.
2. The recruitment end date has been changed from 31/03/2022 to 30/06/2022.
25/02/2022: The recruitment start date has been changed from 25/02/2022 to 07/03/2022.
24/01/2022: The recruitment start date was changed from 25/01/2022 to 25/02/2022.
21/01/2022: The trial participating centres "University Hospital Southampton NHS Foundation Trust", "Royal National Orthopaedic Hospital NHS Trust", "Kent Community Health NHS Foundation Trust", "Solent NHS Trust", and "Walsall Healthcare NHS Trust" have been added and the trial participating centre "Lancashire Care NHS Foundation Trust" has been changed to "Lancashire & South Cumbria NHS Foundation Trust".
20/12/2021: The recruitment start date was changed from 01/01/2022 to 25/01/2022.
14/12/2021: The recruitment start date was changed from 01/12/2021 to 01/01/2022.
19/11/2021: Following NHS REC approved amendment 3 change to protocol the following changes have been made:
1. The study hypothesis has been updated.
2. The study design has been changed from "Interventional randomized controlled trial including a qualitative study within a trial" to "Interventional randomized controlled trial including a qualitative study within a trial and economic evaluation".
3. The intervention has been updated.
4. The target number of participants and the total target enrolment number have been changed from 1055 to 478.
5. The plain English summary has been updated.
08/11/2021: The recruitment start date was changed from 01/11/2021 to 01/12/2021.
12/10/2021: The recruitment start date was changed from 01/10/2021 to 01/11/2021.
21/09/2021: Internal review.
08/09/2021: The recruitment start date was changed from 01/09/2021 to 01/10/2021.
17/08/2021: The following changes have been made:
1. The recruitment start date has been changed from 30/09/2021 to 01/09/2021.
2. The overall trial end date has been changed from 30/09/2023 to 31/03/2023 and the plain English summary updated accordingly.
09/08/2021: The following changes have been made:
1. The recruitment start date has been changed from 15/08/2021 to 30/09/2021.
2. The recruitment end date has been changed from 30/08/2021 to 31/03/2022.
3. The overall trial end date has been changed from 30/11/2022 to 30/09/2023 and the plain English summary has been updated to reflect this change.
4. The intention to publish date has been changed from 30/11/2023 to 14/10/2024.
12/07/2021: The recruitment start date has been changed from 15/07/2021 to 15/08/2021.
01/07/2021: The trial contact has been updated.
24/06/2021: The recruitment start date has been changed from 15/06/2021 to 15/07/2021.
14/06/2021: The following changes were made to the trial record:
1. A scientific contact was changed.
2. The plain English summary was updated to reflect these changes.
11/05/2021: The recruitment start date was changed from 15/05/2021 to 15/06/2021.
13/04/2021: The recruitment start date was changed from 01/04/2021 to 15/05/2021.
09/03/2021: The recruitment start date was changed from 01/03/2021 to 01/04/2021.
20/11/2020: The recruitment start date was changed from 01/11/2020 to 01/03/2021.
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).
