Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/12/2009
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

Prof Nadina Lincoln

ORCID ID

Contact details

School of Psychology
University of Nottingham
University Park
Nottingham
NG7 2RP
United Kingdom
+44 (0)115 9515315

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MS41

Study information

Scientific title

Acronym

Study hypothesis

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

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

The principal measures used at five weeks:
1. Rivermead Motor Assessment Arm Scale
2. Action Research Arm Test.

Secondary outcome measures

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.

Overall trial start date

01/10/1994

Overall trial end date

01/04/1998

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

282 (Added 19/11/09)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/10/1994

Recruitment end date

01/04/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology
Nottingham
NG7 2RP
United Kingdom

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Cardiovascular Disease and Stroke National Research and Development Programme (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

1. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10066854
2. 1999 results on analysis of arm impairment severity in http://www.ncbi.nlm.nih.gov/pubmed/10392645

Publication citations

  1. Results

    Lincoln NB, Parry RH, Vass CD, Randomized, controlled trial to evaluate increased intensity of physiotherapy treatment of arm function after stroke., Stroke, 1999, 30, 3, 573-579.

  2. Results on analysis of arm impairment severity

    Parry RH, Lincoln NB, Vass CD, Effect of severity of arm impairment on response to additional physiotherapy early after stroke., Clin Rehabil, 1999, 13, 3, 187-198.

Additional files

Editorial Notes