Contact information
Type
Scientific
Primary contact
Dr Helen Rodgers
ORCID ID
Contact details
University of Newcastle
Centre for Health Services Research
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
+44 (0)191 222 8025
helen.rodgers@newcastle.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
rctc135 R1805/6630
Study information
Scientific title
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cerebrovascular disease
Intervention
1. Early intensive therapy programme targeting the upper limb (intervention group)
2. Conventional care (control group)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Action Research Arm Test at 6 months post stroke
Secondary outcome measures
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)
Overall trial start date
03/01/1999
Overall trial end date
03/01/2002
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
123 (added 21/01/10; see publication)
Participant exclusion criteria
A register of reasons for exclusion will be kept
Recruitment start date
03/01/1999
Recruitment end date
03/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Newcastle
Newcastle upon Tyne
NE2 4AA
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12971702
Publication citations
-
Results
Rodgers H, Mackintosh J, Price C, Wood R, McNamee P, Fearon T, Marritt A, Curless R, Does an early increased-intensity interdisciplinary upper limb therapy programme following acute stroke improve outcome?, Clin Rehabil, 2003, 17, 6, 579-589.