Condition category
Eye Diseases
Date applied
15/05/2015
Date assigned
19/05/2015
Last edited
12/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
People often develop problems with their vision after a brain injury, such as a stroke. This happens because the visual pathway that carries information from the eye to the brain becomes damaged. The resulting loss of vision can be temporary or permanent and any recovery of a person’s sight may only be partial. Hemianopia is the term used to describe partial blindness in both eyes caused by damage to the visual pathway. This condition is one of the most common and disabling consequences of brain damage, with numerous negative effects on the everyday life of a person with the condition. We have been investigating visual field defects such as hemianopia and have developed rehabilitation training programs for these conditions. The aim of the program is not to restore the lost vision but rather to help people develop strategies to help them overcome the problems they experience due to their disability. Our most recent training program is called Durham Reading and Exploration training (DREX). It is a computer-based and self-adjusted program that allows people to train themselves in their own home. The training involves a series of tasks encouraging visual exploration which become progressively more difficult, helping the patient to develop improvements in their eye-movements and visual awareness. Here, we want to see how well the DREX program works when used as touchscreen tablet app or as a computer program by comparing any changes in visual search and reading speeds of patients before and after they have used the program with another group of patients who are given standard care. If successful, this free and accessible app could benefit many patients, helping them to overcome the disabilities they experience due to visual loss.

Who can participate?
Adults (aged at least 18) suffering with a non-progressive visual field defect for at least 3 months caused by a brain injury.

What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 (intervention group 1) use the DREX program on a touchscreen tablet. Those in group 2 (intervention group 2) use the DREX program on a computer. Those in group 3 (control group) are given their usual care and any treatments given by their doctors or therapists. Participants in all three groups are asked to complete assessments before and after the intervention groups have completed the DREX program to measure their reading and visual search abilities and also their quality of life.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Wolfson Research Institute at Durham University Queen’s Campus (UK)

When is the study starting and how long is it expected to run for?
June 2015 to December 2017

Who is funding the study?
Durham University (UK)

Who is the main contact?
1.Mr Azuwan Musa (scientific)
azuwan.musa@durham.ac.uk
2. Dr Stephen Dunne (public)
drex.training@durham.ac.uk
3. Dr Alison Lane (scientific)

Trial website

www.durham.ac.uk/drex

Contact information

Type

Scientific

Primary contact

Mr Azuwan Musa

ORCID ID

Contact details

Cognitive Neuroscience Research Unit
Wolfson Research Institute
Durham University Queen's Campus
Stockton-on-Tees
TS17 6BH
United Kingdom
+44 (0) 1913340588
azuwan.musa@durham.ac.uk

Type

Public

Additional contact

Dr Stephen Dunne

ORCID ID

Contact details

Cognitive Neuroscience Research Unit
Wolfson Research Institute
Durham University Queen's Campus
Stockton-on-Tees
TS17 6BH
United Kingdom
+44 (0) 191 3340105
drex.training@durham.ac.uk

Type

Scientific

Additional contact

Dr Alison Lane

ORCID ID

http://orcid.org/0000-0001-5962-7543

Contact details

Cognitive Neuroscience Research Unit
Wolfson Research Institute
Durham University Queen's Campus
Stockton-On-Tees
TS17 6BH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of visuomotor compensation training for individuals with a visual field defect

Acronym

Study hypothesis

1. Participants receiving visuomotor training will perform significantly better on measures of reading and visual search than those allocated to standard care
2. Participants receiving computer training will perform significantly better on measures of reading and visual search than those allocated to standard care
3. Visuomotor training is equally effective as computer training on the measures of reading and visual exploration

Ethics approval

1. Ethics Advisory Sub-Committee in Department of Psychology, Durham University, 12/05/2015, ref: 14/32
2. NRES Committee North East – Newcastle & North Tyneside 1, 09/12/2015, ref: 15/NE/0351

Study design

Randomised controlled and parallel trial with three study arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Please use contact details to request a participant information sheet

Condition

Hemianopia following acquired post-chiasmatic brain injury such as stroke

Intervention

1. Two intervention groups, namely visuomotor training and computer training, will do visual exploration and reading training using the DREX (Durham Reading and Exploration) program. The visuomotor training group will do the training on a touchscreen tablet, while the computer training group will run the training using a laptop independently at their home
2. A control group (standard care) will continue any existing treatment given by their doctors or therapists
3. All study groups are required to complete pre- and post-training assessments to measure the reading and visual search ability as well as a several quality of life scales

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Reading is measured using an in-app reading task* and a reading task using a modified passage from ‘The Grey Gentlemen’ (Ende, 1974; Aimola et al., 2014) at baseline, 6 weeks, 12 weeks and 3 months follow up
2.Visual Exploration is measured using an in-app visual exploration task* and the 'Find-the-Number' visual search task (Aimola et al., 2014) at baseline, 6 weeks, 12 weeks and 3 months follow up

* Those described as being ‘in-app’ are part of the Durham Reading and Exploration (DREX) app.

Secondary outcome measures

1. Short-term memory is measured using an in-app short-term memory task* at baseline, 6 weeks, 12 weeks and 3 months follow up
2. Mood and depression is measured using the 21-item Beck Depression Inventory II (BDI II) at baseline, 6 weeks, 12 weeks and 3 months follow up
3. Motivation towards rehabilitation is measured using the 31-item Motivation for Traumatic Brain Injury Rehabilitation Questionnaire (MOT-Q) at baseline, 6 weeks, 12 weeks and 3 months follow up
4. Activities of Daily Living (ADL) is measured using an in-app 6-item ADL questionnaire* and the 10-item Visual Impairment Questionnaire at baseline, 6 weeks, 12 weeks and 3 months follow up
5. Attitude and goals towards rehabilitation is measured using the 10-item Self-Ability and Attitude Questionnaire at baseline, 6 weeks, 12 weeks and 3 months follow up

* Those described as being ‘in-app’ are part of the Durham Reading and Exploration (DREX) app.

Overall trial start date

01/01/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged 18 years or above who have been diagnosed with a non-progressive visual field defect (for at least 3 months) due to post-chiasmatic injury
2. Good cognitive ability
3. Able to give consent

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Individuals with visual field loss due to prechiasmatic or chiasmatic damage, or neurodegenerative disease
2. Aged under 18 years
3. Have comorbid oculomotor disorders
4. Severe physical problems
5. An unstable medical illness
6. Unable to provide informed consent

Recruitment start date

01/06/2015

Recruitment end date

30/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Research Institute
Cognitive Neuroscience Research Unit Department of Psychology Durham University Queen's Campus
Stockton-on-Tees
TS17 6BH
United Kingdom

Sponsor information

Organisation

Ministry of Education Malaysia

Sponsor details

Blok E8
Kompleks E
Pusat Pentadbiran Kerajaan Persekutuan
Putrajaya
62604
Malaysia

Sponsor type

Government

Website

Funders

Funder type

University/education

Funder name

Durham University

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Publication of study results in international peer reviewed journal planned
2. The protocol and trial results of the study may be disseminated in the form of poster or oral presentation at both national and international conferences and meetings. Planned dissemination of the preliminary results in the 12th International Low Vision Research and Rehabilitation (ISLRR) congress, June 2017, in The Netherlands.

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/04/2016: The methods of measurement and timepoints of measurement for the primary and secondary outcome measures have been added, as well as the availability of the participant level data and the publication and dissemination plan. 24/03/2016: Ethics approval information added.