Orthotics for Treatment of Symptomatic Flat Feet in Children (OSTRICH)
Pes Planus
About this trial
This is an interventional treatment trial for Pes Planus focused on measuring Pes planus, Randomised controlled trial, Orthoses, Exercise, Children
Eligibility Criteria
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 Exclusion criteria: Any participant who has withdrawn from the main OSTRICH study or is not due a follow up questionnaire will be excluded.
Sites / Locations
- East Cheshire NHS Trust
- Birmingham Community Healthcare NHS Foundation Trust
- Bolton NHS Foundation Trust
- Cardiff and Vale University Local Health Board
- Medway Community Healthcare
- North Lincolnshire & Goole NHS Foundation Trust
- Harrogate and District Foundation Trust
- Leeds Community Healthcare NHS Trust
- Leeds Teaching Hospitals NHS Trust
- Kent Community Health NHS Foundation Trust
- South Tees Hospitals NHS Foundation Trust
- Lancashire & South Cumbria Nhs Foundation Trust
- University Hospital Southampton NHS Foundation Trust
- Solent NHS Trust
- Royal National Orthopaedic Hospital NHS Trust
- Walsall Healthcare NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Experimental
Experimental
No Intervention
Experimental
No Intervention
Usual supportive care - exercises and footwear advice
Prefabricated, off-the-shelf orthoses
Signposting to multimedia
Standard written information only
Birthday card
No birthday card
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.
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.
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.
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.
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.
OSTRICH Birthday card study within a trial (SWAT) Participants will not be sent a birthday card during the trial.