Condition category
Circulatory System
Date applied
26/05/2011
Date assigned
28/06/2011
Last edited
01/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off, usually by a blood clot blocking an artery or a bleed (haemorrhage). One of the most common complications of a stroke is paralysis on one side of the body (hemiplegia). This can make movements such as walking very difficult and so patients often need extensive physiotherapy to help them recover. An ankle-foot orthosis (AFO) is a brace that is worn on the lower leg and foot. It helps to support the ankle and foot in the correct position, preventing the foot from dragging along the ground. The “tuning” of an AFO describes personalised adjustment so that it helps a person to achieve the best gait (manner of walking) possible. Improving the tuning process of AFO’s could help to improve patient outcomes such as walking speed and posture. Traditionally, tuning of AFO’s is done “by eye” (observation technique), however computers could potentially be used to perfect this process. The aim of this study is to find the most effective way of tuning AFO’s for stroke patients.

Who can participate?
Adults who have had a stroke and have been suffering from hemiplegia within the past year.

What does the study involve?
Participants are randomly allocated into one of two groups which are looked after by a team made up of a physiotherapist, an orthotist (who is responsible for providing the orthosis) and a bioengineer (who will collect data throughout the study). Participants in the first group (intervention group) are shown computerised visualisations in order to help to demonstrate their gait problems and their AFO’s are tuned in line with the visualisations. Participants in the second group (control group) are not shown any visualisations, and their AFO’s are tuned by the team using the traditional observation technique. After 3 and 6 months, all participants have their gait measured using 3D motion analysis software (showing a persons’ movement on a computer in 3D using reflective spots). For participants in the first group, their progress is discussed with their care team using the information from the gait measurements.

What are the possible benefits and risks of participating?
Participants could potentially benefit from an improvement in their gait and the distance they can walk after wearing the AFO. Risks of participating are minor but may include skin irritation from the reflective spots stuck to the skin for the 3D motion analysis. Another possible risk includes the possibility of falling during the walking practice.

Where is the study run from?
University of Strathclyde (UK)

When is the study starting and how long is it expected to run for?
August 2011 to August 2013

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Dr Bruce Carse
bruce.carse@strath.ac.uk

Trial website

http://www.envisagerehab.co.uk

Contact information

Type

Scientific

Primary contact

Dr Bruce Carse

ORCID ID

Contact details

University of Strathclyde
Bioengineering
Wolfson Building
106 Rottenrow East
Glasgow
G4 0NW
United Kingdom
+44 0141 548 3028
bruce.carse@strath.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GN10OR216

Study information

Scientific title

Visualisation to enhance biomechanical tuning of ankle-foot orthoses (AFO) in stroke - a randomised controlled trial

Acronym

Study hypothesis

Can visualisation of biomechanical data improve the tuning of ankle-foot orthoses (AFOs) for stroke patients?

Ethics approval

NHS West of Scotland Research Ethics Committee 4, 1 April 2011 Ref: 11/AL/0166

Study design

Single centre single blind randomised controlled trial

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 patient information sheet

Condition

Stroke

Intervention

1. Patients will be randomised (in blocks of six) to either the intervention or control arm of the study
2. Each arm will have its own multidisciplinary team (MDT)
3. Each of these MDTs will consist of a physiotherapist, orthotist and bioengineer
4. The relevant orthotist will then cast and fit an AFO to to the patient prior to baseline measures being taken
5. Baseline measures: All patients to have baseline gait measurements taken using 3D motion analysis
6. Intervention arm: AFO tuning aided by 3D motion anaylsis and biomechanics visualisation software
7. Control arm: AFO tuning by observation (standard care)
8. Three month measures: all patients to have baseline gait measurements taken using 3D motion analysis
9. Six month measures: all patients to have baseline gait measurements taken using 3D motion analysis
10. Duration from baseline measures will be 6 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Walking velocity
2. Time taken to complete 10m walk test

Secondary outcome measures

1. Lower limb joint kinematics (thigh and shank global orientations) & kinetics (knee and hip flexion/extension moments
2. Ground reaction force Fz2 peak magnitude
3. Step length
4. Gait symmetry
5. Modified Ashworth Scale
6. Abbreviated Rivermead Mobility Index
7. EuroQol (EQ-5D)

Overall trial start date

30/08/2011

Overall trial end date

28/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. In patients who have suffered a recent hemiplegia (within 1 - 12 months)
2. Aged 16 - 80 years
3. Have difficulty walking, but able to walk with/without assistance
4. Have difficulty flexing knee and extending hip during walking
5. Meet the criteria for AFO referral as outlined in AFO screening tool (Appendix 9 of NHS Scotland Best Practice Statement 'Use of AFO follwoing stroke')
6. Able to give informed consent
7. Able to attend for follow-up at 3 and 6 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Unable to give informed consent
2. Unable to walk, even when assisted
3. Suffer from significant peripheral vascular disease − not suitable for fitting of AFO
4. Have any other significant medical problems likely to preclude use of AFO or follow-up

Recruitment start date

30/08/2011

Recruitment end date

28/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Strathclyde
Glasgow
G4 0NW
United Kingdom

Sponsor information

Organisation

University of Strathclyde (UK)

Sponsor details

c/o Ms Louise McKean (Contracts Manager)
Research & Knowledge Exchange Services
50 George Street
Glasgow
G1 1QE
United Kingdom

Sponsor type

University/education

Website

http://www.strath.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/22141471

Publication citations

  1. Study protocol

    Carse B, Bowers RJ, Meadows BC, Rowe PJ, Visualisation to enhance biomechanical tuning of ankle-foot orthoses (AFOs) in stroke: study protocol for a randomised controlled trial., Trials, 2011, 12, 254, doi: 10.1186/1745-6215-12-254.

Additional files

Editorial Notes