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22 May 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Biomechanics visualisation in ankle-foot orthoses (AFO) tuning for stroke |
| ISRCTN | ISRCTN52126764 |
| ClinicalTrials.gov identifier | |
| Public title | Biomechanics visualisation in ankle-foot orthoses (AFO) tuning for stroke |
| Scientific title | Visualisation to enhance biomechanical tuning of ankle-foot orthoses (AFO) in stroke - a randomised controlled trial |
| Acronym | N/A |
| Serial number at source | GN10OR216 |
| Study hypothesis | Can visualisation of biomechanical data improve the tuning of ankle-foot orthoses (AFOs) for stroke patients? |
| Lay summary | Lay summary under review |
| Ethics approval |
NHS West of Scotland Research Ethics Committee 4, 1 April 2011 Ref: 11/AL/0166
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| Study design | Single centre single blind randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 30/08/2011 |
| Anticipated end date | 28/08/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 70 |
| Interventions |
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 |
| Primary outcome measure(s) |
1. Walking velocity
2. Time taken to complete 10m walk test |
| Secondary outcome measure(s) |
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) |
| Sources of funding | Medical Research Council, Lifelong Health and Wellbeing (Phase 2) Ref: G0900583, Grant ref: 91021 |
| Trial website | http://www.envisagerehab.co.uk |
| Publications | 1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/22141471 |
| Contact name | Dr Bruce Carse |
| Address |
University of Strathclyde
Bioengineering Wolfson Building 106 Rottenrow East |
| City/town | Glasgow |
| Zip/Postcode | G4 0NW |
| Country | United Kingdom |
| bruce.carse@strath.ac.uk | |
| Sponsor | University of Strathclyde (UK) |
| Address |
c/o Ms Louise McKean (Contracts Manager)
Research & Knowledge Exchange Services 50 George Street |
| City/town | Glasgow |
| Zip/Postcode | G1 1QE |
| Country | United Kingdom |
| Sponsor website: | http://www.strath.ac.uk/ |
| Date applied | 26/05/2011 |
| Last edited | 10/01/2012 |
| Date ISRCTN assigned | 28/06/2011 |
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