Condition category
Circulatory System
Date applied
06/09/2005
Date assigned
12/09/2005
Last edited
07/10/2009
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 Ailie Turton

ORCID ID

Contact details

University of Bristol
Department of Experimental Psychology
8 Woodland Rd
Bristol
BS8 1TN
United Kingdom
+44 (0)117 9546847
ailie.turton@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSYC.RJ4292

Study information

Scientific title

Acronym

PATMOS

Study hypothesis

1. Does prism adaptation have an effect on the patients’ behaviour in daily living tasks?
2. Does prism adaptation have an effect on the patients’ mobility in the environment?
3. Does prism adaptation differentially affect different domains of space?
4. Are the effects of the treatment long lasting (in this case evident after 8 weeks)?
5. What sample size is required and which measures should be included in a definitive randomised controlled trial?

Ethics approval

Not provided at time of registration

Study design

Randomised placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Stroke

Intervention

Experimental intervention: Pointing training with prism goggles that shift field of view 10 degrees to the right, once a day, Monday to Friday for 2 weeks.
Control intervention: pointing training with goggles containing clear flat glass, once a day, Monday to Friday for 2 weeks.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Score of selfcare on Catherine Bergego Scale at 3 days after end of intervention

Secondary outcome measures

1. Behavioural inattention test
2. Corridor navigation (distance from wall)
3. Motricity index
4. Sensory Assessment
5. Barthel Index

Overall trial start date

01/12/2004

Overall trial end date

31/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Right hemisphere damaged stroke patients who are judged by their Occupational Therapists to be having difficulty with self-care as a result of unilateral inattention.
2. Scoring below cut off on Star Cancellation and Line Bisection tests from the Behavioural Inattention Test.
3. Able to sit and point with the unaffected hand.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Patients judged unable to follow instructions for the study procedures

Recruitment start date

01/12/2004

Recruitment end date

31/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS8 1TN
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research and Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)117 9288676
red-office@bristol.ac.uk

Sponsor type

University/education

Website

http://www.bris.ac.uk/research/

Funders

Funder type

Charity

Funder name

The Stroke Association (UK) (ref: TSA 2004/01)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19629848

Publication citations

  1. Results

    Turton AJ, O'Leary K, Gabb J, Woodward R, Gilchrist ID, A single blinded randomised controlled pilot trial of prism adaptation for improving self-care in stroke patients with neglect., Neuropsychol Rehabil, 2010, 20, 2, 180-196, doi: 10.1080/09602010903040683.

Additional files

Editorial Notes