Ankle Sprain Strain Clinical Trial
Official title:
A Prospective Randomised Control Study in 6-16 Year Old Children Presenting to Sheffield Children's NHSFT With Stable Ankle Injuries That Would Otherwise Have Received Cast Immobilisation.
Present treatment of children with stable ankle and foot injuries very often involves a
period in plaster cast(s). In the last decade in adult patients this has been superceded in
many instances by the use of a removable foot brace/splint.
There are many benefits to this approach including progressive rehabilitation, reduced costs
in materials and personnel, improved hygiene and adaptability of fit. The use of such a
splint has not been investigated in children and this project aims to assess the value of
introducing this as a treatment mode through the analysis of outcomes between traditional
cast treatment and the newer removable brace/splint treatment. The outcomes will include
patients' preferences, clinical results and relative costings.
The study is a longitudinal cohort study of all eligible ankle injuries per the eligibility
criteria presenting to Sheffield Children's NHS Fountain Trust. These children and their
parents/carers are presented with an information sheet regarding the study and are then
invited to enter the study.
Once consented - by appropriately trained research and/or clinical staff - those recruited
are treated in either cast or boot on the basis of block randomisation.
Patients are followed up per protocol and outcomes completed by patients and clinicians.
Study information is kept securely for future analysis and write up.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06188416 -
Changes in Dynamic q Angle in Patients With Chronic Ankle Instability
|