Contact information
Type
Scientific
Primary contact
Dr Patrick Gompertz
ORCID ID
Contact details
Dept of Medicine for the Elderly
Bancroft Road
London
E1 4DG
United Kingdom
+44 (0)20 7377 7843
patrick.gompertz@thpct.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0261154762
Study information
Scientific title
Acronym
Study hypothesis
To assess whether the methods and protocols used are feasible to conduct a main study in the future.
Ethics approval
Ethics approval was received from the local medical ethics committee before trial recruitment began.
Study design
Randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular: Acute stroke
Intervention
A randomised controlled trial comparing a four-week programme of taping with routine rehabilitation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Baseline assessments will be made by three different independent assessors, at 1, 2, 3, 4, and 6 weeks. At these times measures of motor function (as measured by the Monitor Assessment Scale), upper limb motor recovery (assessed with the Fugl Meyer arm score), and upper limb motor function (assessed with the 9-hole peg set) will be made.
Secondary outcome measures
Generic health-related quality of life questionnaire and a disease-specific measure, both administered at 6 and 12 weeks.
Overall trial start date
01/06/2004
Overall trial end date
01/11/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients admitted to the Royal London Hospital with a diagnosis of unilateral supratentorial stroke
2. With minor to moderate hemiplegia
3. Cardiovascularly stable
4. Medically well
5. Have mild to moderate central arm paresis
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
1. Patients with hemianopia
2. Major somatosensory disturbance
3. Reduction of sensation to light touch and position sense deficit
4. Severe premorbid shoulder pathology and shoulder surgery
5. Any cognitive dysfunction of such severity that is incompatible with treatment participation (Mini Mental State [MMS]<8)
6. Patients who sweat profusely
Recruitment start date
01/06/2004
Recruitment end date
01/11/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of Medicine for the Elderly
London
E1 4DG
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Tower Hamlets Primary Care Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nursing, Midwifery and Allied Health Professionals Award - Barts and The London 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
Basic results (scientific)
Publication list
Pilot study not published - part of degree.