Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/01/2016
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

Ms Frederike van Wijck

ORCID ID

Contact details

School of Health Sciences
Queen Margaret University College
Leith Campus
Duke Street
Edinburgh
EH6 8HF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0165121638

Study information

Scientific title

Upper limb rehabilitation for chronic stroke patients: integrating motor control and learning concepts

Acronym

Study hypothesis

1. Is the use of botulinum toxin and physiotherapy in patients with a stroke more effective than botulinum toxin alone?
2. Which of two different forms of physiotherapy are more effective - motor learning with and without visual information.

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

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular: Stroke

Intervention

All patients will receive botulinum toxin as usual. This is a randomised, single-blind, placebo controlled study. Patients will be randomised to receiving placebo (upper limb splint), or one of two types of motor learning.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Activities of daily life; Quality of Life measure; Action research arm test; Fugl-Meyer and other similar measures.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

A minimum of 26 patients post stroke. This will include males and females. All patients will be 20-80 years and there will be a mixture of inpatients and outpatients.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

26

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2001

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Margaret University College
Edinburgh
EH6 8HF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Northgate and Prudhoe NHS Trust (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

Publication citations

Additional files

Editorial Notes

26/01/2016: no publications found on PubMed.