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| [ ...Back to search results ] | [ Print-friendly version ] |
| Getting Out of The House: A multicentre trial to evaluate an outdoor mobility intervention for people who have had a stroke |
| ISRCTN | ISRCTN58683841 |
| ClinicalTrials.gov identifier | |
| Public title | Getting Out of The House: A multicentre trial to evaluate an outdoor mobility intervention for people who have had a stroke |
| Scientific title | A multicentre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people who have had a stroke |
| Acronym | TOMAS (Trial of Outdoor Mobility After Stroke) |
| Serial number at source | HTA 08/14/51 |
| Study hypothesis |
What is the clinical effectiveness and cost effectiveness of treating outdoor mobility limitations after stroke with a novel targeted rehabilitation therapy intervention?
More details can be found at http://www.hta.ac.uk/project/1863 As of 13/07/2009 this record has been updated to include amendments to the inclusion and exclusion criteria. At this time, the anticipated trial dates have also been updated; the initial information at the time of registration was as follows: Initial anticipated start date: 01/03/2009 initial anticipated end date: 28/02/2012 Further modifications to this record took place on 15/09/2009, and again on 12/03/2010. |
| Lay summary | |
| Ethics approval | Received from the Nottingham Research Ethics Committee (REC) 1 on the 15th June 2009 (ref: 09/H0403/55) |
| Study design | Multicentre parallel-group individually randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke |
| Participants - inclusion criteria |
Amended as of 12/03/2010:
Point 2 below has been amended to read as follows: 2. At least six weeks since stroke Amended as of 15/09/2009: 1. Age 18 years or over 2. At least six weeks but no longer than five years since stroke 3. Wishing to get out of the house more often 4. The participant must give informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal care. Amended as of 13/07/2009: 1. Aged 18 years or over, either sex 2. At least six weeks but no longer than five years since stroke 3. Wishing to get out of the house more often 4. Able to comply with the requirements of the protocol and therapy programme 5. The participant must give informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal care Initial information at time of registration: 1. Both males and females, aged 18 years or over 2. At least six weeks since stroke 3. Wishing to get out of the house more often 4. Able to comply with the requirements of the protocol and therapy programme 5. The participant or legal representative must give informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal care |
| Participants - exclusion criteria |
Amended as of 15/09/2009:
1. Not able to comply with the requirements of the protocol and therapy programme, in the opinion of the assessor 2. Still in post-stroke intermediate care or active rehabilitation 3. Previous enrolment in this study Amended as of 13/07/2009: 1. Significant cognitive impairment which will impede ability to complete the assessments 2. Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. terminal illness 3. Still in post-stroke intermediate care or active rehabilitation 4. Previous enrolment in this study Initial information at time of registration: 1. Significant cognitive impairment which will impede ability to complete the assessments 2. Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. terminal illness 3. Previous enrolment in this study |
| Anticipated start date | 01/08/2009 |
| Anticipated end date | 31/07/2012 |
| 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 | 676 |
| Interventions |
A novel rehabilitation technique (intervention) group will be compared to a usual care (control) group:
Intervention group: Specifically designed outdoor mobility training and practice with a skilled health professional. Intervention group participants will receive up to 7 rehabilitation outdoor mobility sessions of about an hour each over 4 months. The main component of the intervention is that therapists go repeatedly with patients to try outdoor mobility, including buses, taxis, walking, voluntary drivers and mobility scooters until they feel confident to go alone or with a companion. Control group: Standard verbal and written information about outdoor mobility from a skilled health professional. Control Group participants will receive what is considered clinically to be routine intervention for outdoor mobility limitations. That is, verbal advice and provision of leaflets provided over one 1-hour session. |
| Primary outcome measure(s) | Social Function domain of the health related quality of life measure SF-36v2™ Health Survey at 6 months. |
| Secondary outcome measure(s) |
The following will be assessed at 6 and 12 months:
1. Functional ability, measured by the Nottingham Extended Activities of Daily Living Scale 2. Mobility using the Rivermead Mobility Index 3. Modified 15/09/09: The number of journeys (travel diaries) - was previously: The number and duration of journeys from the travel diaries 4. Satisfaction with outdoor mobility, assessed using one yes/no question: "Do you get out of the house as much as you would like?" 5. Mood, using the General Health Questionnaire 12 6. Carer psychological distress, measured using the General Health Questionnaire 12pt 7. EuroQol EQ-5D 8. Resource use of health and social care 9. Provision of equipment 10. Participant mortality will be collected from medical records |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Pip Logan |
| Address |
B98, Community Health Sciences
Queens Medical Centre |
| City/town | Nottingham |
| Zip/Postcode | NG7 2UH |
| Country | United Kingdom |
| pip.logan@nottingham.ac.uk | |
| Sponsor | University of Nottingham (UK) |
| Address | Research Innovation Services |
| City/town | Nottingham |
| Zip/Postcode | NG7 2NR |
| Country | United Kingdom |
| Sponsor website: | http://www.nottingham.ac.uk/ |
| Date applied | 30/01/2009 |
| Last edited | 12/03/2010 |
| Date ISRCTN assigned | 09/02/2009 |
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