|
ISRCTN
|
ISRCTN44717376
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Clinical Effectiveness of Shoulder Taping versus Routine Rehabilitation in Acute Stroke Patients: A Pilot Study
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0261154762
|
|
Study hypothesis
|
To assess whether the methods and protocols used are feasible to conduct a main study in the future.
|
|
Lay summary
|
|
|
Ethics approval
|
Ethics approval was received from the local medical ethics committee before trial recruitment began.
|
|
Study design
|
Randomised controlled pilot study
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cardiovascular: Acute stroke
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/06/2004
|
|
Anticipated end date
|
01/11/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
30
|
|
Interventions
|
A randomised controlled trial comparing a four-week programme of taping with routine rehabilitation.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
Generic health-related quality of life questionnaire and a disease-specific measure, both administered at 6 and 12 weeks.
|
|
Sources of funding
|
1. Tower Hamlets Primary Care Trust (UK)
2. Nursing, Midwifery and Allied Health Professionals Award - Barts and The London NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
Pilot study not published - part of degree.
|
|
Contact name
|
Dr
Patrick
Gompertz
|
|
Address
|
Dept of Medicine for the Elderly
Bancroft Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
E1 4DG
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7377 7843
|
|
Fax
|
+44 (0)20 7377 7844
|
|
Email
|
patrick.gompertz@thpct.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2005
|
|
Last edited
|
08/09/2008
|
|
Date ISRCTN assigned
|
30/09/2005
|