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| [ ...Back to search results ] | [ Print-friendly version ] |
| Augmented visual feedback with gait training in sub-acute stroke |
| ISRCTN | ISRCTN79005974 |
| ClinicalTrials.gov identifier | |
| Public title | Augmented visual feedback with gait training in sub-acute stroke |
| Scientific title | Augmented visual feedback of biomechanical movement performance to enhance walking recovery after stroke: a pilot randomised controlled trial |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | Can visualisation of biomechanical movement performance during rehabilitation enhance mobility outcomes after stroke? |
| Lay summary | Lay summary under review |
| Ethics approval | West of Scotland Research Ethics Committee 4 approved on 26 April 2011, Ref: 11/AL/0184 |
| Study design | Single blind single centre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke |
| Participants - inclusion criteria |
1. Patients in early supported discharge (ESD) service with clinical diagnosis of stroke
2. In sub-acute stage of stroke (up to three months from time of onset) 3. Aged more than or equal to 18 years 4. Exhibit an abnormal gait pattern 5. Able to walk with/without assistance Functional Ambulation Categories (FAC) score 1 or more 6. Medically stable and hence suitable for physical mobility rehabilitation 7. Able to understand and follow simple instructions 8. Able to give informed consent when assisted to do so with suitable communication aids if required |
| Participants - exclusion criteria |
1. Severe visual or cognitive problems precluding participation study
2. Pre-existing lower limb deficits or any other medical comorbidities which interfere significantly with gait 3. Involved in any other research trials |
| Anticipated start date | 01/09/2011 |
| Anticipated end date | 01/03/2013 |
| 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 | 45 |
| Interventions |
1. All participants to have baseline gait measurements
1.1. This will involve recording participants walking over a high contrast grid mat whilst wearing small bullseye markers on their lower body 1.2. Video footage will allow for assessment of clinical outcomes and temporal and spatial parameters 2. Impairment levels of memory, attention and neglect will also be assessed 3. Randomisation: participants will randomised into 1 of the 3 following arms: 3.1. Control: usual routine standard care (SC) only 3.2. Placebo: SC + gait training 3.3. Experimental: SC + gait training with augmented visual feedback 4. Gait training in the placebo and experimental groups will consist of a selection of pre-designed walking related exercises, from which the study therapist will be able to choose depending on the individual participant’s level of impairment 5. 3D motion analysis will be used to measure the movements of both groups, however only the experimental group will be provided with feedback 6. Augmented visual feedback will be in the form of a stick-like figure that will mimic the movements of the participant 7. This will allow the participant to see how they move, either in real-time or post hoc, during walking and related exercises Intervention period: 1. Participants in the placebo and experimental groups will attend their respective gait training sessions twice a week for 6 weeks 2. Each session will last 1 hour 3. Participants in the control group will be expected to attend their usual routine care only 4. 6 week measures: All patients to have gait measurements as described for baseline 5. 6 month measures: All patients to have gait measurements as described for baseline 6. A questionnaire will also be given to assess the participants’ experiences of the study 7. Participants will be involved in the study for 6 months in total |
| Primary outcome measure(s) | Walking speed (time taken to complete 5m walk test) |
| Secondary outcome measure(s) |
1. Functional ambulation classification
2. Timed up and go 3. Rivermead visual gait assessment 4. Temporal and spatial parameters associated with walking 5. Stroke impact scale-16 6. Adherence (attendance and drop-out rate) 7. Safety (number and nature of adverse events) |
| Sources of funding | Medical Research Council (MRC) (UK)- Lifelong Health and Wellbeing (Phase 2) Ref number: G0900583, Grant ID: 91021 |
| Trial website | |
| Publications | |
| Contact name | Miss Heather Thikey |
| Address |
Bioengineering
Wolfson Building University of Strathclyde 106 Rottenrow |
| City/town | Glasgow |
| Zip/Postcode | G4 0NW |
| Country | United Kingdom |
| heather.thikey@strath.ac.uk | |
| Sponsor | University of Strathclyde (UK) |
| Address |
c/o Ms Louise McKean (Contracts Manager)
Research & Knowledge Exchange Services University of Strathclyde 50 George Street |
| City/town | Glasgow |
| Zip/Postcode | G1 1QE |
| Country | United Kingdom |
| Sponsor website: | http://www.strath.ac.uk/ |
| Date applied | 14/06/2011 |
| Last edited | 21/09/2011 |
| Date ISRCTN assigned | 21/09/2011 |
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