Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes