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| [ ...Back to search results ] | [ Print-friendly version ] |
| Augmented visual feedback in upper limb stroke rehabilitation |
| ISRCTN | ISRCTN14268457 |
| ClinicalTrials.gov identifier | |
| Public title | Augmented visual feedback in upper limb stroke rehabilitation |
| Scientific title | The impact of augmented visual feedback in upper limb rehabilitation in sub-acute stroke: a pilot randomised controlled trial |
| Acronym | N/A |
| Serial number at source | G0900583 |
| Study hypothesis | Does the use of augmented visual feedback of biomechanical movement performance in upper limb rehabilitation improve functional outcomes after stroke? |
| Lay summary | Lay summary under review |
| Ethics approval | NHS West of Scotland Research Ethics Committee 2 approved on 15 June 2011, REC reference number: 11/AL/0260 |
| Study design |
Interventional single-blind single centre randomised controlled trial
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| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke |
| Participants - inclusion criteria |
1. Aged more than or equal to 18 years
2. Clinical diagnosis of stroke 3. Sub-acute stage of stroke (up to three months from time of onset of stroke) 4. Some movement in affected arm and/or hand - Action Research Arm Test (ARAT) score of 4-56 (57 max score) 5. Medically stable hence suitable for physical rehabilitation 6. Ability to understand and follow simple instructions 7. Able to give informed consent when assisted to do so with suitable communication aids |
| Participants - exclusion criteria |
1. Pre-existing upper limb deficits
2. Bilateral arm impairments 3. Severe visual or cognitive problems precluding participation in study protocol 4. Involved in any other intervention study |
| Anticipated start date | 01/10/2011 |
| Anticipated end date | 01/04/2013 |
| 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 |
Stroke patients with upper limb impairments who meet inclusion criteria will be randomised into one of three groups:
1. Control group: This is standard care (SC) only and is usual therapy that would be provided, i.e. from the Early Supported Discharge (ESD) team. 2. Placebo group: Upper limb therapy focusing on reach and grasp, the same exercises as for the intervention group but without visual feedback. This will take place at a community-based clinic, one hour twice a week for six weeks, in addition to any received SC. 3. Intervention Group: One hour of enhanced upper limb therapy twice a week at a community-based clinic for 6 weeks, in addition to any SC. During the sessions patients will receive augmented visual feedback during upper limb exercises. |
| Primary outcome measure(s) | Arm function as assessed by the Action Research Arm Test (ARAT) at baseline, six weeks and six months |
| Secondary outcome measure(s) |
1. Kinematic (temporal and spatial parameters) assessment measured using sensors worn during a section of the ARAT
2. Hand function as measured by the 9 Hole Peg Test 3. Stroke Impact Scale - to evaluate quality of life and disability changes Measured at baseline, six weeks and six months Additional outcome measures: 1. A patient and therapist questionnaire at 6 weeks to assess the acceptance of the visualisation system from their perspective 2. The safety of intervention assessed by number and nature of adverse events at end of intervention period and at follow up 3. Acceptance of the visualisation system will be assessed by withdrawal or dropout rates from study |
| Sources of funding | Medical Research Council (MRC) (UK) - Lifelong Health and Wellbeing (Phase 2), Ref number: G0900583, Grant ID: 91021 |
| Trial website | http://www.envisagerehab.co.uk/content/wp4a-envisage-stroke-rehabilitation-upper-limb |
| Publications | |
| Contact name | Miss Lucy Jones |
| Address |
Department of Bioengineering
Wolfson Building University of Strathclyde 106 Rottenrow |
| City/town | Glasgow |
| Zip/Postcode | G4 0NW |
| Country | United Kingdom |
| Tel | +44 (0) 141 548 3028 |
| lucy.jones@strath.ac.uk | |
| Sponsor | University of Strathclyde (UK) |
| Address |
Contracts Manager
c/o Louise McKean 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 | 10/08/2011 |
| Last edited | 21/09/2011 |
| Date ISRCTN assigned | 21/09/2011 |
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