Does an early intensive interdisciplinary upper limb therapy programme following acute stroke improve outcome?

ISRCTN	ISRCTN92548182
DOI	https://doi.org/10.1186/ISRCTN92548182
Secondary identifying numbers	rctc135 R1805/6630

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

University of Newcastle
Centre for Health Services Research
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom

Phone	+44 (0)191 222 8025
Email	helen.rodgers@newcastle.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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 study start date	03/01/1999
Completion date	03/01/2002

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	123 (added 21/01/10; see publication)
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

England
United Kingdom

Study participating centre

University of Newcastle

Newcastle upon Tyne
NE2 4AA
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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