Title: Ankle Foot Orthoses (AFO) for people with stroke
Funder: Department of Health (England)

Abstract: Background Walking difficulties after stroke can be treated with a foot-drop splint (or AFO) which stops the toes catching when stepping. The National Stroke Guidelines recommend the use of AFOs because of good evidence they can improve walking speed. The guidelines also recommend that a bespoke AFO should be fitted. However off-the-shelf AFOs are often used in clinical practice as they are cheaper and quicker to fit. The Guidelines are based on expert opinion as there is no research comparing different AFOs to tell us which is the best. The research has also focussed on the short-term effects on walking impairments; important clinical issues such as the long-term effects, acceptability to patients, adverse events and effects on disability have not been addressed. Aims Using the MRC Framework for Developing and Evaluating Complex Interventions model, we will compare patients’ satisfaction with the two most commonly prescribed types of AFO; bespoke and off-the-shelf, to • establish the feasibility of using the off-the-shelf AFO for people with stroke • compare the acceptability and clinical effectiveness of bespoke and off-the-shelf AFOs • identify the patient groups for whom each AFO is effective • identify the outcomes affected by the AFOs and the effect sizes • obtain information about recruitment, adherence and completion rates As well as delivering immediate benefits, the results will inform a definitive Phase III trial, funding for which will be sought from the HTA Programme Plan of Investigation We plan a multi-centre randomised controlled study to compare commonly used examples of the two types of AFO. In response to reviewers’ comments on our previous application, the primary outcome measure will be patients’ long term satisfaction. Secondary outcomes will be short-term satisfaction, adverse events, adherence to using the AFO, functional mobility and walking impairments. Participants will be stratified according to their functional mobility and recruited through the North-West Stroke and Primary Care Research Networks. They will be people with stroke who have completed their rehabilitation, able to walk at least 10 metres but whose walking is limited by impaired dorsiflexion. The AFOs will be fitted by the orthotists delivering the clinical service in the participating trusts. Potential Impact AFOs are beginning to be prescribed more frequently so it is important, for both the NHS and patients, to determine which work best, which patients prefer and which provide the best value for money. The results will enable the National Stroke Guidelines to be updated which will have national impact. There will also be an immediate impact on clinical practice and service planning by providing information about the feasibility of using an off-the-shelf AFO as ‘stock’ provision, rates of adverse events and adherence, and an indication of the type of patients that benefits from each type of AFO; data which will be used by the Greater Manchester Cardiac and Stroke Network’s stroke rehabilitation group to plan service provision for patients with stroke.


Research activity codes: 6.3 MEDICAL DEVICES
Health categories: STROKE