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| [ ...Back to search results ] | [ Print-friendly version ] |
| Does an early intensive interdisciplinary upper limb therapy programme following acute stroke improve outcome? |
| ISRCTN | ISRCTN92548182 |
| ClinicalTrials.gov identifier | |
| Public title | Does an early intensive interdisciplinary upper limb therapy programme following acute stroke improve outcome? |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | rctc135 R1805/6630 |
| Study hypothesis |
To evaluate an early intensive interdisciplinary upper limb therapy programme for patients with acute stroke.
Objectives 1. To compare the upper limb impairment and function of stroke patients who receive an early intensive therapy programme targeting the upper limb (the intervention group) with those receiving conventional care (the control group) at 3 and 6 months post stroke. 2. To compare disability and quality of life of the intervention and control group at 3 and 6 months post stroke. 3. To compare the prevalence of post stroke upper limb pain between the intervention and control group at 3 and 6 months post stroke. 4. To develop a joint physiotherapy and occupational therapy record for the intervention group. 5. To describe and quantify the therapy received by the intervention and control group in the 6 months post stroke. 6. To elicit the vies of patients and carers about the therapy they have received. 7. To determine the net financial costs and benefits of an early intensive upper limb therapy programme following acute stroke. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cerebrovascular disease |
| Participants - inclusion criteria |
All patients admitted to North Tyneside General Hospital within 10 days of acute stroke who are resident within the borough will be assessed against the following eligibility criteria:
1. Pre-stroke Oxford Handicap Scale 1-3 2. Motor impairment of the upper limb 3. Medically stable 4. No previous major upper limb problem likely to influence assessments 5. Patient able to give informed consent |
| Participants - exclusion criteria | A register of reasons for exclusion will be kept |
| Anticipated start date | 03/01/1999 |
| Anticipated end date | 03/01/2002 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 123 (added 21/01/10; see publication) |
| Interventions |
1. Early intensive therapy programme targeting the upper limb (intervention group)
2. Conventional care (control group) |
| Primary outcome measure(s) | Action Research Arm Test at 6 months post stroke |
| Secondary outcome measure(s) |
1. Motricity score (3 months and 6 months post stroke)
2. Upper limb function assessed by: 2.1. Action Research Arm Test (3 months) 2.2. Frenchay arm test (3 months and 6 months) 3. Disability assessed by Nottingham Extended Activities of Daily Living (E-ADL) (3 months and 6 months) 4. Nottingham Health Profile (6 months) 5. Upper limb pain (3 months and 6 months) 6. Patient and carer satisfaction (modified Hospsat & Homsat 6 months) |
| Sources of funding | NHS Executive Northern and Yorkshire (UK) |
| Trial website | |
| Publications | 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12971702 |
| Contact name | Dr Helen Rodgers |
| Address |
University of Newcastle
Centre for Health Services Research 21 Claremont Place |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE2 4AA |
| Country | United Kingdom |
| Tel | +44 (0)191 222 8025 |
| Fax | +44 (0)191 222 6043 |
| helen.rodgers@newcastle.ac.uk | |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Address |
The Department of Health
Richmond House 79 Whitehall |
| City/town | London |
| Zip/Postcode | SW1A 2NL |
| Country | United Kingdom |
| Tel | +44 (0)20 7307 2622 |
| Fax | +44 (0)20 7307 2623 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.doh.gov.uk |
| Date applied | 23/01/2004 |
| Last edited | 21/01/2010 |
| Date ISRCTN assigned | 23/01/2004 |
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