Can a computer game designed to rehabilitate young people with visual field loss improve functional vision?

ISRCTN	ISRCTN90462176
DOI	https://doi.org/10.1186/ISRCTN90462176
Secondary identifying numbers	KTP 008989

Submission date: 09/12/2013
Registration date: 29/01/2014
Last edited: 11/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The visual field is the portion of the space around a person that can be seen at any one time without moving the eyes. Damage or disease to areas of the brain which process vision can result in a loss of part of the usual field of vision. Recent research has shown that certain rehabilitation approaches can be used to improve the functional vision of adult stroke patients with visual field loss. One particular method has been to use specialised computer software that requires visually scanning the images displayed on a monitor. However, these tools are typically too boring and often unable to engage young people for the long periods required for training to be effective. We are carrying out a feasibility study to pilot a computer game designed to rehabilitate young people with visual field loss. Our goal is to determine whether this training is effective in improving functional vision and to explore the potential of computer games technology to increase engagement with rehabilitation programmes.

Who can participate?
Young people between the ages of 7 and 25 years old can participate if they have a visual field loss due to damage or disease of the visual pathway in the brain. Potential participants must be able to perform a standard automated visual field assessment and have the capability of using a mouse, keyboard or touch screen to play the computer game.

What does the study involve?
All participants will receive the rehabilitation programme. The study involves a 6-week rehabilitation programme where participants are invited to play a computer game at home. Each session takes about half an hour to complete and participants will be asked to complete 30 sessions over the 6-week period (about 5 sessions per week). Participants will be asked to take part in four assessments of their vision one month before the programme, immediately before and after the programme, and one month after the programme.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement in functional vision as part of the rehabilitation programme, and information obtained from this study may benefit future vision rehabilitation programmes by helping us to develop strategies that are more engaging for young people. Repetitive strain injuries have been associated with excessive use of computer games so the rehabilitation programme only allows the player to complete one session per day. Very rarely young people with epilepsy may be photosensitive, which means that flashing lights or certain colour sequences can trigger seizures. To minimise these risks we will be excluding potential participants with photosensitive epilepsy from this study.

Where is the study run from?
The study has been set up by the University of Lincoln and the WESC Foundation in Exeter. Vision assessments will be performed at the WESC Foundation or at Bristol Eye Hospital.

When is the study starting and how long is it expected to run for?
The study is expected to start in April 2014 and is expected to run until November 2014 or until the required number of participants have been recruited and assessed.

Who is funding the study?
The study is being jointly funded by the Technology Strategy Board, Medical Research Council and the WESC Foundation, UK.

Who is the main contact?
Dr Jonathan Waddington
jwaddington@wescfoundation.ac.uk

Contact information

Dr Jonathan Waddington
Scientific

WESC Foundation
Topsham Road
Countess Wear
Exeter
EX2 6HA
United Kingdom

ORCID ID	0000-0003-4676-1748
Phone	+44 (0)1392 454349
Email	jwaddington@wescfoundation.ac.uk

Study information

Study design	Case series intervention and feasibility study (interrupted time series design)
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	ISRCTN90462176_PIS_17Mar15_V5_ParentsCarers.pdf
Scientific title	Can a computer game designed to rehabilitate young people with visual field loss improve functional vision? A case series intervention and feasibility study
Study objectives	Visual field loss is a visual impairment caused by damage to the visual pathway or areas of the brain that process vision, which results in missing areas of vision. This study will assess whether a computer game that has been designed to rehabilitate young people with visual field loss can improve their functional vision. Current study hypothesis as of 18/07/2018: Hypothesis 1: We anticipate that rehabilitation using the computer game will lead to improvements in the speed and efficiency of day-to-day activities that require visual search, and improvements in patient-reported outcome measures of functional vision and quality of life. Previous study hypothesis: Hypothesis 1: We anticipate that rehabilitation using the computer game will lead to improvements in the speed and efficiency of day-to-day activities that require visual search, and improvements in patient-reported outcome measures of functional vision and quality of life. Hypothesis 2: We do not anticipate a significant improvement in the border of the visual field.
Ethics approval(s)	NRES Committee North East Newcastle & North Tyneside 1, 30/05/2014, ref: 14/NE/0097
Health condition(s) or problem(s) studied	Visual field loss
Intervention	All participants will receive training that will consist of playing the computer game for approximately 20-30 minutes to complete one session, and completing five sessions per week for 6 weeks (30 training sessions in total). Four assessments of functional vision will be undertaken: one month before the rehabilitation programme begins, immediately before and immediately after the rehabilitation, and one month after the rehabilitation ends.
Intervention type	Other
Primary outcome measure	The speed at which participants perform 'activities of daily living' (ADLs), measured one month before the rehabilitation programme begins, immediately before and immediately after the rehabilitation, and one month after the rehabilitation ends.
Secondary outcome measures	Current secondary outcome measures as of 18/07/2018: 1. Scores on two patient-reported outcome questionnaires: 1.1. The Impact of Vision Impairment for Children (IVI_C) and 1.2. The Cardiff Visual Ability Questionnaire for Children (CVAQC) Measured one month before the rehabilitation programme begins, immediately before and immediately after the rehabilitation, and one month after the rehabilitation ends. Previous secondary outcome measures: 1. Perimeter and size of the visual field border 2. Scores on two patient-reported outcome questionnaires: 2.1. The Impact of Vision Impairment for Children (IVI_C) and 2.2. The Cardiff Visual Ability Questionnaire for Children (CVAQC) 3. Speed at which participants perform a mobility course and the percentage of brightly coloured cards found that are placed along the route. Measured one month before the rehabilitation programme begins, immediately before and immediately after the rehabilitation, and one month after the rehabilitation ends.
Overall study start date	01/02/2013
Completion date	31/01/2017

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	10
Total final enrolment	9
Key inclusion criteria	Current inclusion criteria as of 18/07/2018: Young people (7-25 years old, male and female) with bilateral visual field loss caused by a lesion of the post-geniculate optic pathway or visual cortex Previous inclusion criteria: Young people (8-25 years old, male and female) with bilateral visual field loss caused by a lesion of the post-geniculate optic pathway or visual cortex
Key exclusion criteria	1. Cognitive or physical impairments which cause a formal assessment of the visual field (standard automated perimetry) to be impractical 2. The inability to use either a mouse, keyboard or touch screen to access the game
Date of first enrolment	01/07/2014
Date of final enrolment	31/07/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

WESC Foundation

Topsham Road
Exeter
EX2 6HA
United Kingdom

University of Lincoln

Brayford Pool
Lincoln
LN6 7TS
United Kingdom

Bristol Eye Hospital

Lower Maudlin Street
Bristol
BS1 2LX
United Kingdom

Torbay Hospital

Lowes Bridge
Torquay
TQ2 7AA
United Kingdom

Royal Devon & Exeter Hospital

Barrack Road
Exeter
EX2 5DW
United Kingdom

Sponsor information

University of Lincoln (UK)
University/education

c/o Professor Sara Owen
Brayford Pool
Lincoln
LN6 7TS
England
United Kingdom

Website	http://www.lincoln.ac.uk
"ROR"	https://ror.org/03yeq9x20

Funders

Funder type

Research council

Technology Strategy Board
Private sector organisation / For-profit companies (industry)

Alternative name(s): TSB
Location: United Kingdom

WESC Foundation (UK)

No information available

Medical Research Council
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date	30/09/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer reviewed journal.
IPD sharing plan	The datasets generated and analysed during the current study are available upon request from jwaddington@wescfoundation.ac.uk

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version V5	17/03/2015	02/06/2017	No	Yes
Participant information sheet	version V6	17/03/2015	02/06/2017	No	Yes
Participant information sheet	version V6	17/03/2015	02/06/2017	No	Yes
Participant information sheet	version V6	17/03/2015	02/06/2017	No	Yes
Basic results		12/07/2018	18/07/2018	No	No
Results article	results	01/11/2018		Yes	No
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN90462176_PIS_17Mar15_V6_7-12.pdf: Uploaded 02/06/2017
ISRCTN90462176_PIS_17Mar15_V6_12-16.pdf: Uploaded 02/06/2017
ISRCTN90462176_PIS_17Mar15_V6_16-25.pdf: Uploaded 02/06/2017
ISRCTN90462176_PIS_17Mar15_V5_ParentsCarers.pdf: Uploaded 02/06/2017
ISRCTN90462176_BasicResults_12Jul18.pdf: Uploaded 18/07/2018

Editorial Notes

11/03/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
18/07/2018: The following changes were made to the trial record:
1. The secondary outcome measures, hypothesis and inclusion criteria were updated.
2. The intention to publish date was changed from 31/12/2017 to 30/09/2018.
3. The basic results of this trial have been uploaded as an additional file.
02/06/2017: The following changes have been made to the record:
1. The overall trial dates have been updated from 01/04/2014 - 01/11/2014 to 01/02/2013 - 31/01/2017
2. The recruitment dates have been updated from 01/04/2014 - 01/11/2014 to 01/07/2014 - 31/07/2016
3. The trial participating centres, publication and dissemination plan, ORCID ID and IPD sharing statement have been added
4. The participant information sheets have been uploaded