Condition category
Circulatory System
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
17/12/2012
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 Marion Walker

ORCID ID

Contact details

Division of Rehabilitation and Ageing
B Floor Medical School
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3918

Study information

Scientific title

A neuropsychological approach to dressing versus the conventional approach (commonly used by occupational therapists in the UK in patients after stroke

Acronym

DRESS

Study hypothesis

The ability to dress oneself is often taken for granted by the able bodied, yet this intimate task remains a problem for 36% of stroke patients who still can’t dress independently at one year after the onset of stroke.

Although a simple problem solving approach to dressing problems has been demonstrated to be effective, it is known that therapists are still unaware of the best methods to teach patients to overcome their dressing problems if they have accompanying cognitive difficulties.

In the DRESS study our aim is to conduct a two part study. The first part will develop a definitive treatment manual for the cognitive impairments most commonly affecting dressing performance. The second part will be a feasibility randomised controlled trial. This trial will compare a neuropsychological approach (n = 35) to dressing, with the conventional approach (n = 35) commonly used by occupational therapists in the UK.

Ethics approval

Nottingham Research Ethics Committee 1 approved on the 13th November 2007 (ref: 07/H0403/130)

Study design

Randomised interventional process of care and treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Community study

Intervention

Patients are randomised to one of two treatment groups:
Group 1: Routine care which involves the provision of standard dressing practice as given by occupational therapists in the UK
Group 2: neuropsychological intervention dressing practice as prescribed by a newly compiled manual.

Both interventions are described in 2 study treatment manuals. Treatment for both groups is assigned 3 x per week for 6 weeks duration.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Dressing ability as assessed on the Nottingham Stroke Dressing Assessment (NDSA), collected at baseline and outcome (8 weeks after randomisation)

Secondary outcome measures

Measured 8 weeks after randomisation:
1. NSDA
2. Line cancellation
3. Gesture imitation
4. 10 hole peg test
5. Object decision

Overall trial start date

01/03/2008

Overall trial end date

30/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (aged over 18 years, either sex) will be included if they are impaired on one or more items in a brief cognitive screening test:
1. Line cancellation
2. 10-hole peg test with non-paretic hand
3. Object decision
4. Gesture imitation
5. Unable to dress after two weeks of conventional rehabilitation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 70; UK Sample Size: 70

Participant exclusion criteria

1. Inability to tolerate sitting in a chair for 15 minutes
2. Pre-morbid disability (Rankin greater than 3)
3. Known diagnosis of depression or dementia

Recruitment start date

01/03/2008

Recruitment end date

30/11/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Rehabilitation and Ageing
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/ris/

Funders

Funder type

Charity

Funder name

The Stroke Association (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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22180445

Publication citations

  1. Results

    Walker MF, Sunderland A, Fletcher-Smith J, Drummond A, Logan P, Edmans JA, Garvey K, Dineen RA, Ince P, Horne J, Fisher RJ, Taylor JL, The DRESS trial: a feasibility randomized controlled trial of a neuropsychological approach to dressing therapy for stroke inpatients., Clin Rehabil, 2012, 26, 8, 675-685, doi: 10.1177/0269215511431089.

Additional files

Editorial Notes