Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/09/2008
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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Pilot study not published - part of degree.

Publication citations

Additional files

Editorial Notes