Rehabilitation of arm function

ISRCTN	ISRCTN22921641
DOI	https://doi.org/10.1186/ISRCTN22921641
Protocol serial number	MS41
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	After 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) studied	Stroke rehabilitation
Intervention	Participants 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 type	Other
Primary outcome measure(s)	The principal measures used at five weeks: 1. Rivermead Motor Assessment Arm Scale 2. Action Research Arm Test.
Key secondary outcome measure(s)	Other 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.
Completion date	01/04/1998

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	282
Key inclusion criteria	Patients 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 criteria	Does not match inclusion criteria
Date of first enrolment	01/10/1994
Date of final enrolment	01/04/1998

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Psychology

Nottingham
NG7 2RP
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	01/03/1999		Yes	No
Results article	results on analysis of arm impairment severity	01/06/1999		Yes	No