Does an early intensive interdisciplinary upper limb therapy programme following acute stroke improve outcome?
| ISRCTN | ISRCTN92548182 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92548182 |
| Protocol serial number | rctc135 R1805/6630 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 21/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helen Rodgers
Scientific
Scientific
University of Newcastle
Centre for Health Services Research
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
| Phone | +44 (0)191 222 8025 |
|---|---|
| helen.rodgers@newcastle.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cerebrovascular disease |
| Intervention | 1. Early intensive therapy programme targeting the upper limb (intervention group) 2. Conventional care (control group) |
| Intervention type | Other |
| Primary outcome measure(s) |
Action Research Arm Test at 6 months post stroke |
| Key secondary outcome measure(s) |
1. Motricity score (3 months and 6 months post stroke) |
| Completion date | 03/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 123 |
| Key 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 |
| Key exclusion criteria | A register of reasons for exclusion will be kept |
| Date of first enrolment | 03/01/1999 |
| Date of final enrolment | 03/01/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Newcastle
Newcastle upon Tyne
NE2 4AA
United Kingdom
NE2 4AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2003 | Yes | No |
