Pes PlanusOSTRICHNCT04104555
Orthotics for Treatment of Symptomatic Flat Feet in Children
A study testing Birthday card, Prefabricated orthoses and Signposting to multimedia in people with Pes Planus, run by University of York at 16 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Birthday card, Prefabricated orthoses and Signposting to multimedia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 16 sitesUnited Kingdom
- Study dates
- 21 Apr 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
OSTRICH main trial inclusion criteria:
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
OSTRICH main trial exclusion criteria:
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).
OSTRICH signposting to multimedia trial information SWAT: inclusion criteria any potential participant identified as eligible to be sent trial information from a site taking part in the SWAT, will be eligible for the study.
OSTRICH birthday card SWAT Inclusion criteria: All participants recruited into the host trial will be eligible to take part in this SWAT. Exclusion criteria: Any participant who has withdrawn from the main OSTRICH study or is not due a follow up questionnaire will be excluded.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United Kingdom16 sites
Birmingham Community Healthcare NHS Foundation Trust
Birmingham, B7 4BN
Bolton NHS Foundation Trust
Bolton, BL4 OJR
Cardiff and Vale University Local Health Board
Cardiff, CF14 4XW
Medway Community Healthcare
Gillingham, ME8 0PZ
North Lincolnshire & Goole NHS Foundation Trust
Goole
Harrogate and District Foundation Trust
Harrogate, HG2 7SX
Leeds Community Healthcare NHS Trust
Leeds, LS6 1PF
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
East Cheshire NHS Trust
Macclesfield, Cheshire, SK10 3BL
Kent Community Health NHS Foundation Trust
Maidstone, ME16 9NT
South Tees Hospitals NHS Foundation Trust
Middlesbrough, TS4 3BW
Lancashire & South Cumbria Nhs Foundation Trust
Preston, PR5 6AW
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Solent NHS Trust
Southampton
Royal National Orthopaedic Hospital NHS Trust
Stanmore, HA7 4LP
Walsall Healthcare NHS Trust
Walsall
About this study
Official title: Orthotics for Treatment of Symptomatic Flat Feet in Children the OSTRICH Study
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.
Read more
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.
Read the detailed description
The aim of the study is to undertake a large, pragmatic, multi-armed, randomised controlled trial to assess the clinical and cost-effectiveness of prefabricated orthoses in addition to exercises and advice compared with exercises and advice alone on the physical functioning of children with symptomatic flat feet. We will aim to recruit 478 children with flat feet. They will be allocated to one of two groups, in a 1:1 ratio to either (a) prefabricated orthoses plus exercises and footwear advice or (b) exercises and footwear advice only. We will follow the participants up for 12 months after randomisation to assess their physical functioning, levels of pain and quality of life. We will undertake qualitative interviews with approximately 30 children and their parents, to find out about their experiences of having flat feet, and of being in the trial.
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
- Pes Planus
- Being tested
- Birthday card, Prefabricated orthoses, Signposting to multimedia, Usual supportive care - exercises and footwear advice (the comparator)
- Keywords
- Pes planus, Randomised controlled trial, Orthoses, Exercise, Children
- Medical subject headings
- Flatfoot, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birthday cardOther
Birthday card sent to participants in the post
Prefabricated orthosesDevice
Prefabricated insole
Signposting to multimediaOther
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)Other
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Usual supportive care - exercises and footwear advice | Active comparator | 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. Receives: Other: Usual supportive care - exercises and footwear advice (the comparator) |
| Prefabricated, off-the-shelf orthoses | Experimental | 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. Receives: Device: Prefabricated orthoses |
| Signposting to multimedia | Experimental | 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. Receives: Other: Signposting to multimedia |
| Standard written information only | No intervention | 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. |
| Birthday card | Experimental | 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. Receives: Other: Birthday card |
| No birthday card | No intervention | OSTRICH Birthday card study within a trial (SWAT) Participants will not be sent a birthday card during the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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). However for the secondary outcome we will use the 'School and Play' domain. There are 4 items on the 'School and Play' 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 of the 'School and Play' domain score is divided by the maximum for the domain ie 16. 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.
Measured: Collected at baseline, 3,6 and 12 months post randomisation
The 'Emotional' subscale of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
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). However for the secondary outcome we will use the 'Emotional' domain. There are 4 items on the 'Emotional' 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 of the 'Emotional' domain score is divided by the maximum for the domain score ie 16. 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.
Measured: Collected at baseline, 3,6 and 12 months post randomisation
Footwear item of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
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. This item was added to reflect the concern by many children that they can or cannot wear the footwear they prefer. It is 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. It is reported as a single item with higher score representing better functioning. This will be rated by the child (participant) and their parent/legal guardian using a proxy version.
Measured: Collected at baseline, 3, 6 and 12 months post randomisation
EuroQoL-Five Dimension Youth
The EuroQoL-5 Dimension Youth (EQ5DY) is a child friendly, generic quality of life measure. Health status is measured in terms of 5 domains: "mobility", "looking after myself", "doing usual activities", "having pain or discomfort" and "feeling worried, sad or unhappy". Each dimension has 3 levels ranging from 1 no problems, 2 some problems and 3 a lot of problems. The respondent is asked to indicate their health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. From these 5 dimensions an EuroQoL-5 Dimension Youth (EQ5DY) value is calculated. This measure also includes a Visual Analogue Scale on how good or bad the participant's health is "today", on a vertical scale of 0 to 100. The endpoints of the scale are labelled "100 The best health you can imagine" and "0 The worst health you can imagine." This will be rated by the child (the participant) and their parent/legal guardian (using a proxy version).
Measured: Collected at baseline, 3,6 and 12 months post randomisation
Child Health Utility 9D (CHU9D)
The Child Health Utility 9D (CHU9D) is a paediatric self-reported generic quality of life measure. It consists of nine dimensions; "worried", "sad", "pain", "tiredness" "annoyed", "school work/homework", "sleep", "daily routine" and "able to join in activities". The measure is rated on a five point scale on which the participants rate the level to how they are feeling, with a "don't" sentence linked with no problems (e.g. I don't feel sad today) and "very" with the participant experiencing a lot of problems (e.g. I feel very sad). Calculation of an universal score is supported by a specific scoring algorithm, with 1 representing 'full health' and 0 'death'. In this study the CHU9D is rated by the child (the participant) and their parent/legal guardian (using a proxy version).
Measured: Collected at baseline, 3,6 and 12 months post randomisation
Foot pain score measured by numeric rating scale
Self-report pain status will be measured using a Numeric Rating Scale (NRS) of 0 to 9. The participant will be asked to estimate their pain intensity over the past week, where 0 indicates no pain at all and 9 the worst pain. In this study the foot pain score with numeric rating is rated by the participant's parent/legal guardian .
Measured: Collected once a week for 12 weeks and at baseline, 3, 6 and 12 months post randomisation
Healthcare resource use
Self report healthcare resource use. Healthcare utilisation will be recorded in primary care and the community and within the hospital setting.
Measured: Collected at baseline, 3,6 and 12 months post randomisation
Foot pain over past week measured by Wong-Baker Faces pain rating scale
Self-report measure of pain in left and right feet, using Wong-Baker faces pain rating scale (0-10) where 0 indicates no pain at all and 10 being the worst possible pain. In this study the foot pain score is rated by the child (the participant).
Measured: Collected at baseline, 3,6 and 12 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start21 Apr 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of York
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, University of Salford, University of Oxford, King's College London, University of Warwick
- Responsible party
- Principal investigator, Sarah Cockayne, University of York
- Investigators
- David Torgerson, PhD, Principal investigator, University of York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104555
- Sponsor's protocol ID
- 265719
- Acronym
- OSTRICH
- Status last verified
- Nov 2023
- First submitted
- 19 Sep 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35080267Evans 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.
PubMed 35029841
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthotics for Treatment of Symptomatic Flat Feet in Children the OSTRICH Study
- ClinicalTrials.gov ID
- NCT04104555
- Acronym / sponsor ID
- OSTRICH / 265719
- Conditions
- Pes Planus
- Keywords
- Pes planus, Randomised controlled trial, Orthoses, Exercise, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of YorkUniversity, hospital or other
- Collaborators
- University of Leeds, University of Salford, University of Oxford, King's College London, University of Warwick
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of the study is to undertake a large, pragmatic, multi-armed, randomised controlled trial to assess the clinical and cost-effectiveness of prefabricated orthoses in addition to exercises and advice compared with exercises and advice alone on the physical functioning of children with symptomatic flat feet. We will aim to recruit 478 children with flat feet. They will be allocated to one of two groups, in a 1:1 ratio to either (a) prefabricated orthoses plus exercises and footwear advice or (b) exercises and footwear advice only. We will follow the participants up for 12 months after randomisation to assess their physical functioning, levels of pain and quality of life. We will undertake qualitative interviews with approximately 30 children and their parents, to find out about their experiences of having flat feet, and of being in the trial.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Usual supportive care - exercises and footwear advice | Active comparator | Other: Usual supportive care - exercises and footwear advice (the comparator)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. |
| Prefabricated, off-the-shelf orthoses | Experimental | Device: Prefabricated orthosesOSTRICH 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 | Experimental | Other: Signposting to multimediaOSTRICH '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 intervention | –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. |
| Birthday card | Experimental | Other: Birthday cardOSTRICH 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 intervention | –OSTRICH Birthday card study within a trial (SWAT) Participants will not be sent a birthday card during the trial. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Birthday cardBirthday card sent to participants in the post | Other | Birthday card |
| Prefabricated orthosesPrefabricated insole | Device | Prefabricated, off-the-shelf orthoses |
| Signposting to multimediaSignposting to multimedia information in the patient information sheet which is sent to participants in the post as part of the OSTRICH recruitment pack. | Other | Signposting to multimedia |
| Usual supportive care - exercises and footwear advice (the comparator)Active comparator | Other | Usual supportive care - exercises and footwear advice |
Primary outcome
Physical domain subscale of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) over the 12 month follow-up period.
Time frame: 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
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.
8 secondary outcomes
The 'School and Play' domain of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
Time frame: Collected at baseline, 3,6 and 12 months post randomisation
The 'Emotional' subscale of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
Time frame: Collected at baseline, 3,6 and 12 months post randomisation
Footwear item of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
Time frame: Collected at baseline, 3, 6 and 12 months post randomisation
EuroQoL-Five Dimension Youth
Time frame: Collected at baseline, 3,6 and 12 months post randomisation
Child Health Utility 9D (CHU9D)
Time frame: Collected at baseline, 3,6 and 12 months post randomisation
Foot pain score measured by numeric rating scale
Time frame: Collected once a week for 12 weeks and at baseline, 3, 6 and 12 months post randomisation
Healthcare resource use
Time frame: Collected at baseline, 3,6 and 12 months post randomisation
Foot pain over past week measured by Wong-Baker Faces pain rating scale
Time frame: Collected at baseline, 3,6 and 12 months post randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 35080267Evans 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.
- Derived from this study: PubMed 35029841Evans 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Torgerson, PhD principal investigator
University of York
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Birthday card, Prefabricated orthoses and Signposting to multimedia in people with Pes Planus, run by University of York at 16 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical domain subscale of the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) over the 12 month follow-up period. (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04104555, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.