Eye-movement training improves reading function in children and young people with eye-movement disorders after acquired brain injury
| ISRCTN | ISRCTN14668034 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14668034 |
- Submission date
- 17/09/2024
- Registration date
- 22/09/2024
- Last edited
- 08/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Acquired brain injury (ABI) often causes a worsening of reading function. This may decrease motivation for school activities. Eye-movement training has been shown to have positive effects, but its feasibility and effectiveness are unknown, as is its optimal duration, frequency and intensity. The aim was to develop and evaluate eye-movement training for children and young people with ABI.
Who can participate?
Children and young people aged between 10-19 years old with eye-movement disorders after ABI
What does the study involve?
The intervention involves 20 minutes of training each day for three weeks. Each participant and caregiver will be introduced to the home training program and will receive individual support by phone calls and/or text messages during the intervention. Vision assessments, a reading speed test and a survey will record results at baseline, at the end of the training, and three months after the end of the training.
What are the possible benefits and risks of participating?
The participants might benefit regarding their reading function, and possible risks including headaches from the training are expected to be minimal.
Where is the study run from?
The study is run from the Child and Youth Rehabilitation Center in Lund, Sweden.
When is the study starting and how long is it expected to run for?
January 2020 and February 2024
Who is funding the study?
Region Skåne (Sweden)
Who is the main contact?
Dr. Katarina Lauruschkus, katarina.lauruschkus@med.lu.se
Contact information
Public, Scientific, Principal Investigator
Brannarevagen 6
Veberöd
24763
Sweden
 ORCID ID |
0000-0002-1801-8503 |
|---|---|
| Phone | +46 0707519888 |
| katarina.lauruschkus@med.lu.se |
Study information
| Study design | Single-centre interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Care home, Hospital, Internet/virtual, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Eye-movement training improves reading function in children and young people with eye-movement disorders after acquired brain injury |
| Study objectives | Three weeks of eye-movement training is feasible and improves the reading function in children and young people with eye-movement disorders after acquired brain injury. |
| Ethics approval(s) |
Approved 20/11/2020, Swedish Ethical Review Authority (Box 2110, Uppsala, SE-750 02, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: EPM-Dnr 2020-04154 |
| Health condition(s) or problem(s) studied | Eye-movement disorders after acquired brain injury |
| Intervention | The materials for the eye-movement training with instructions were provided for each participant by the occupational therapist or the special education teacher. The materials are described and visualized in the manuscript that will be submitted and is available upon request. The intervention involves 20 minutes of training each day for three weeks. Each participant and caregiver is introduced to the home training program and receives individual support during the intervention. Vision assessments, a reading speed test and a survey records results at baseline, at the end of the training, and three months after the end of the training. The paediatrician, the occupational therapist and the special education teacher all worked at the Child and Youth Rehabilitation Center and were trained for the intervention. They were all well experienced for working with the target group. |
| Intervention type | Behavioural |
| Primary outcome measure | Reading speed measured using a reading speed test at baseline, at the end of the training, and three months after the end of the training |
| Secondary outcome measures | Clinical signs of convergence insufficiency measured using vision assessments and the modified Convergence Insufficiency Symptom Survey (CISS) at baseline, at the end of the training, and three months after the end of the training |
| Overall study start date | 25/01/2020 |
| Completion date | 20/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 10 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | 17 |
| Total final enrolment | 16 |
| Key inclusion criteria | 1. Aged 10-19 years old 2. Eye-movement disorders after ABI 3. Live in the Skåne Region in Southern Sweden 4. Being followed up by the Child and Youth Rehabilitation Center in Lund, Sweden 5. Able to read independently before the injury |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 20/11/2020 |
| Date of final enrolment | 12/11/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Lund
22100
Sweden
Sponsor information
Government
Department of Habilitation, Committee on Psychiatry, Habilitation and Technical Aids, Dockplatsen 26
Malmoe
211 74
Sweden
| Phone | +46 44 309 41 31 |
|---|---|
| petra.bovide@skane.se | |
| Website | https://www.skane.se/ |
Funders
Funder type
Government
Government organisation / Local government
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| 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 analyzed during the current study will be available upon request from Katarina Lauruschkus, katarina.lauruschkus@med.lu.se |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Poster results | 06/09/2022 | 20/09/2024 | No | No |
Additional files
Editorial Notes
08/10/2024: Sponsor details updated.
18/09/2024: Study's existence confirmed by the Swedish Ethical Review Authority.
