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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19629848
Publication citations
-
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.