Condition category
Circulatory System
Date applied
08/12/2014
Date assigned
06/05/2015
Last edited
21/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Stroke is a serious, life-threatening medical condition that usually happens when a blood clot or haemorrhage cuts of the blood supply to an area of the brain. Symptoms vary according to how much of the brain is affected and where in the brain the stroke occurs, but includes paralysis, muscle weakness and speech difficulties. For most patients a stroke causes a weakness down one side of the body which often makes it difficult to walk. One way to manage this is to use a splint, called an ankle-foot orthosis or AFO, which supports the foot and ankle so the toes don’t catch when stepping forwards. Although research shows that an AFO can improve walking there is none comparing different types of AFO to tell us which is the best to use. We want to compare two commonly used types of AFO; a custom made, and an ‘off-the-shelf’ one. We want to find out:
1. Whether the AFOs work, what effects they have and how big the effects are .
2. Which type of patient the AFOs work for.
3. Whether they cause side effects and how serious the side effects are.
4. Information about recruitment, adherence and completion rates.

Who can participate?
Adults who have had a stroke, able to walk 5m with or without a walking aid and fulfil the criteria to be referred to a orthotics service.

What does the study involve?
Participants are randomly allocated into one of three different groups. Those in group 1 are given standard care. Those in group 2 are given a off-the-shelf AFO. Those in group 3 are given a custom made AFO. Each participant is followed-up to measure the effects of the AFO six weeks and three months after they have been referred to their local orthotics service. Patient satisfaction with their AFO, how much they use it, how mobile wearing it makes them, how it affects the way in which they walk (walking pattern) and any side effects (such as pain or falls) are all assessed.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Stroke & Vascular Research Centre, University of Manchester (UK)

When is the study starting and how long is it expected to run for?
January 2012 to June 2015

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Professor Sarah Tyson
sarah.tyson@manchester.ac.uk

Trial website

www.strokeresearch.org.uk

Contact information

Type

Public

Primary contact

Dr Sarah Tyson

ORCID ID

http://orcid.org/0000-0001-6301-8791

Contact details

Professor of Rehabilitation
Stroke & Vascular Research Centre
School of Nursing
Midwifery & Social Work
Jean McFarlane Building
University of Manchester
Oxford Rd
Manchester
M13 9PL
United Kingdom
44 (0)161 306 7781
sarah.tyson@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

59338/GM

Study information

Scientific title

Which is the better ankle foot orthosis for people with stroke?

Acronym

AFOOT

Study hypothesis

Using the model in the MRC Framework for Developing and Evaluating Complex Interventions, patients’ satisfaction with the two most commonly prescribed types of AFO; bespoke and off-the-shelf will be evaluated, to:
1. Establish the feasibility of the off-the-shelf AFO for people with stroke
2. Compare the acceptability and clinical effectiveness of bespoke and off-the-shelf AFOs
3. Identify the patient groups for whom each AFO is effective
4. Identify the outcomes affected by the AFOs and the effect sizes
5. Obtain information about recruitment, adherence and completion rates to inform a definitive Phase III trial.

Ethics approval

North West 12 Research Ethics Committee - Lancaster, 19/07/2011, ref: 11/NW/0352


Study design

UK multicentre RCT feasibility Ttrial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Stroke

Intervention

Two types of ankle foot orthosis (AFO) prescribed to correct foot drop. Participants are randomised to either an off-the-shelf, commonly used medium priced Leaf Spring AFO; or a custom made AFO, where the design is decided by the clinical orthotist. Both AFO are offered as standard care.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Patient Satisfaction Questionnaire

Measured at week 6 and 12.

Secondary outcome measures

1. Walking speed and gait analysis, measured by the GAITRite automated walkway & manual counts of speed and step count over 5m (measured at baseline, 6 weeks and 12 weeks)
2. Modified Functional Walking Categories (MFWC) (measured at baseline, 6 weeks and 12 weeks)
3. Falls Efficacy Scale - International (FES-I) (measured at baseline, 6 weeks and 12 weeks)

Overall trial start date

01/01/2012

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Have a diagnosis of stroke
2. Be living at home or residential care (or in hospital with discharge plans confirmed)
3. Satisfy the referral criteria to their local Orthotics Service
4. Have impaired dorsiflexion – which limits heel strike (the heel hits the ground first when taking a step forwards)
5. Have no contractures at the ankle (sufficient range of movement at the affected ankle for the heel to be in contact with the floor while standing)
6. Be able to walk 5m (approx across a typical living room), without the assistance of another person but maybe with the assistance of a walking aid
7. Be able to consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

166

Participant exclusion criteria

1. Any co-morbities of sufficient severity to limit mobility
2. Any condition which precludes them from wearing an AFO (e.g., severely oedematous ankles/feet; severe skin conditions/abrasions; inability to wear footwear)

Recruitment start date

01/07/2012

Recruitment end date

30/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Stroke & Vascular Research Centre
School of Nursing, Midwifery & Social Work Jean McFarlane Building University of Manchester Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
44 (0) 161 275 7583
research-governance@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Data Analysis to be completed January 2015
2. Report and publications depending on the results

Intention to publish date

30/06/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26680020

Publication citations

Additional files

Editorial Notes

21/12/2015: Publication reference added.