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
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