Biomechanics visualisation in ankle-foot orthoses (AFO) tuning for stroke

ISRCTN ISRCTN52126764
DOI https://doi.org/10.1186/ISRCTN52126764
Secondary identifying numbers GN10OR216
Submission date
26/05/2011
Registration date
28/06/2011
Last edited
17/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Study website

Contact information

Dr Bruce Carse
Scientific

University of Strathclyde
Bioengineering
Wolfson Building
106 Rottenrow East
Glasgow
G4 0NW
United Kingdom

Phone +44 0141 548 3028
Email bruce.carse@strath.ac.uk

Study information

Study designSingle-centre single-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleVisualisation to enhance biomechanical tuning of ankle-foot orthoses (AFO) in stroke - a randomised controlled trial
Study objectivesCan visualisation of biomechanical data improve the tuning of ankle-foot orthoses (AFOs) for stroke patients?
Ethics approval(s)NHS West of Scotland Research Ethics Committee 4, 01/04/2011, ref: 11/AL/0166
Health condition(s) or problem(s) studiedStroke
Intervention1. 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure1. Walking velocity
2. Time taken to complete 10m walk test
Secondary outcome measures1. 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 study start date30/08/2011
Completion date28/08/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants70
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment30/08/2011
Date of final enrolment28/08/2013

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

University of Strathclyde
Glasgow
G4 0NW
United Kingdom

Sponsor information

University of Strathclyde (UK)
University/education

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

Website http://www.strath.ac.uk/
ROR logo "ROR" https://ror.org/00n3w3b69

Funders

Funder type

Research council

Medical Research Council
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 05/12/2011 Yes No

Editorial Notes

17/12/2020: Internal review.
22/11/2018: No publications found, verifying study status with principal investigator.