ISRCTN ISRCTN22921641
DOI https://doi.org/10.1186/ISRCTN22921641
Secondary identifying numbers MS41
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
21/12/2009
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

Prof Nadina Lincoln
Scientific

School of Psychology
University of Nottingham
University Park
Nottingham
NG7 2RP
United Kingdom

Phone +44 (0)115 9515315

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesAfter suffering a stroke most patients have problems using the affected arm and hand, but achieve varying degrees of recovery over the ensuing months. Most patients receive routine physiotherapy.
The aim of this study was to investigate the use of more intensive physiotherapy to see if this improved arm and hand function.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedStroke rehabilitation
InterventionParticipants were allocated to one of three treatment groups
1. Routine physiotherapy (RPT)
2. Qualified physiotherapist (QPT)
3. Assistant physiotherapist (APT)
The patients in the last group were assessed initially by a qualified physiotherapist who then supervised the treatment of each patient by the assistant weekly. Routine physiotherapy involved about 2-3 hours a week for all disabilities, while patients in the other two groups received 2 hours of additional treatment for their arm each week for 5 weeks (ten hours in total).
Intervention typeOther
Primary outcome measureThe principal measures used at five weeks:
1. Rivermead Motor Assessment Arm Scale
2. Action Research Arm Test.
Secondary outcome measuresOther tests measured
1. dexterity
2. grip
3. motor function
4. self- care
5. other daily living abilities
The later assessments comprised four of these tests.

Outcomes were assessed after five weeks, three months, and six months.
Overall study start date01/10/1994
Completion date01/04/1998

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants282 (Added 19/11/09)
Key inclusion criteriaPatients with admitted to Nottingham City Hospital following a stroke were entered in the study between one and five weeks later, after giving consent. All patients had normal arm function prior to the stroke, and were assessed as able to accept the physiotherapy programme.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/10/1994
Date of final enrolment01/04/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Psychology
Nottingham
NG7 2RP
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

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

Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/1999 Yes No
Results article results on analysis of arm impairment severity 01/06/1999 Yes No