Evaluation of Neuropsychological Interventions on visual function in low vision children: A single arm clinical trial
Design
The single arm clinical trial was conducted with a 5-person group of visually impaired children. The method has the following three features:
1. Repeated measurements during a trial of the dependent variable.
2. Run multiple test situations for each participant (for example, each person is in both the trial (intervention) and baseline (control) positions.
3. Each participant is considered as a basis for comparing effectiveness of experimental situation.
The reason for choosing such a plan is that each person can be in both a control and an intervention position, while being repeatedly measured in each position to ensure consistency in the individual's score and readiness to move to the next position.
Settings and conduct
The single arm clinical trial applied on 5 children with low vision in dark room of Tavakol rehabilitation center.
All 5 low vision children were initially given 4 sessions in baseline (control), then 8 sessions in experimental (intervention) and 4 sessions in baseline (control) again, at the end of each session was measured their visual function.
Participants/Inclusion and exclusion criteria
1. age : 4 between 6
2. exclude other sensitive defect
3.exclude autism
4. exclude ADHD
Intervention groups
Intervention involves training and rehabilitation on a group of 5 visually impaired children by applying rehabilitation exercises implemented on the optical stimulus system.
Main outcome variables
Upgrading the subjects in the following variables:
1. Light Detection
2. Color Perception
3. Color Recognition
4. Shape Recognition
5. Shape Recognition from background
6. Detail Recognition
7. Visual Tracking
8. Visual Memory and sequence of Visual Memory
9. Eye-hand coordination
10. Depth Detection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190620043955N1
Registration date:2019-12-08, 1398/09/17
Registration timing:retrospective
Last update:2019-12-08, 1398/09/17
Update count:0
Registration date
2019-12-08, 1398/09/17
Registrant information
Name
Elaheh Moazeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3230 0141
Email address
moazeni.bme@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-02-18, 1397/11/29
Actual recruitment start date
2019-01-20, 1397/10/30
Actual recruitment end date
2019-02-18, 1397/11/29
Trial completion date
2019-03-19, 1397/12/28
Scientific title
Neuropsychological Interventions on low vision children
Public title
The effect of educational and visual rehabilitation exercises on the visual function of low vision children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a defect in eyesight- Being visually impaired
Having aged 4-6 years
Exclusion criteria:
Lack of ADHD
Lack of Autism
Lack of defect in other senses
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
5
Actual sample size reached:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib street, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
IR.MUI.REC.1396.3.961
Health conditions studied
1
Description of health condition studied
Low vision
ICD-10 code
H54.2
ICD-10 code description
Low vision, both eyes
Primary outcomes
1
Description
1. Light Detection
Timepoint
Total number of sessions: 16, 4 session per week, 1 houre for every session (4 sessions before intervention, 8 sessions intervention and 4 sessions after intervention)
Method of measurement
complete case report form based on Likert scale
2
Description
2. Color Perception
Timepoint
Total number of sessions: 16, 4 session per week, 1 houre for every session (4 sessions before intervention, 8 sessions intervention and 4 sessions after intervention)
Method of measurement
complete case report form based on Likert scale
3
Description
3. Color Recognition
Timepoint
Total number of sessions: 16, 4 session per week, 1 houre for every session (4 sessions before intervention, 8 sessions intervention and 4 sessions after intervention)
Method of measurement
complete case report form based on Likert scale
4
Description
4. Shape Recognition
Timepoint
Total number of sessions: 16, 4 session per week, 1 houre for every session (4 sessions before intervention, 8 sessions intervention and 4 sessions after intervention)
Method of measurement
complete case report form based on Likert scale
5
Description
5. Shape Recognition from background
Timepoint
Total number of sessions: 16, 4 session per week, 1 houre for every session (4 sessions before intervention, 8 sessions intervention and 4 sessions after intervention)
Method of measurement
complete case report form based on Likert scale
6
Description
6. Detail Recognition
Timepoint
Total number of sessions: 16, 4 session per week, 1 houre for every session (4 sessions before intervention, 8 sessions intervention and 4 sessions after intervention)
Method of measurement
complete case report form based on Likert scale
7
Description
7. Visual Tracking
Timepoint
Total number of sessions: 16, 4 session per week, 1 houre for every session (4 sessions before intervention, 8 sessions intervention and 4 sessions after intervention)
Method of measurement
complete case report form based on Likert scale
8
Description
8. Visual Memory and sequence of Visual Memory
Timepoint
Total number of sessions: 16, 4 session per week, 1 houre for every session (4 sessions before intervention, 8 sessions intervention and 4 sessions after intervention)
Method of measurement
complete case report form based on Likert scale
9
Description
9. Eye-hand coordination
Timepoint
Total number of sessions: 16, 4 session per week, 1 houre for every session (4 sessions before intervention, 8 sessions intervention and 4 sessions after intervention)
Method of measurement
complete case report form based on Likert scale
10
Description
10. Depth Detection
Timepoint
Total number of sessions: 16, 4 session per week, 1 houre for every session (4 sessions before intervention, 8 sessions intervention and 4 sessions after intervention)
Method of measurement
complete case report form based on Likert scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention involves training and rehabilitation on a group of 5 visually impaired children by applying rehabilitation exercises implemented on the optical stimulus system. The clinical trial applied in dark room of Tavakol rehabilitation center. All 5 low vision children were initially given 4 sessions in baseline (control), then 8 sessions in experimental (intervention) and 4 sessions in baseline (control) again, at the end of each session was measured their visual function.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tavakol Rehabilitation Center of Family and Low Vision and Blindness Children