Comparison of the effect of Phonological Awareness (PA), grapheme to phoneme knowledge treatments, and transcranial direct current stimulation (TDCS) on PA and reading skills in reading disabled students.
The use of combination therapy (instrumental and behavioral) and comparison of treatment results with behavioral therapy on phonological awareness (PA) skills (Phoneme: The sounds of a language that the words are created by putting the phonemes together. PA: The ability to consciously identify and manipulate phonemes and change their position in the word and thus change the word to another one. Example: The phoneme "s" is changed in the word "sir" and the phoneme "sh" is replaced and the word "sir" is changed to "shir") and word and non-word reading
Design
A concealed, randomized, blinded, sham-active clinical trial with a parallel-group design of 28 patients, enrolled between December 2020 and Juan 2021 and followed for one month
Settings and conduct
Intervention in this study in a private clinic in Tehran by a therapist for 15 sessions. Both participants and therapist are blind to whether the participant is in the control or intervention group
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Having a mental age commensurate with the second to fifth grades
- Non-verbal intelligence benefit above 80
- Having phonological dyslexia
- Being monolingual (Persian)
Criteria for not entering:
- Having a history of speech therapy in the field of language therapy, especially phonological awareness,
Having comorbidities or disorders including: hearing loss, epilepsy, IQ, attention deficit / hyperactivity disorder
- Taking drugs related to diseases of the nervous system
- The presence of a metal object (shunt, etc.) in the head and neck
- The presence of a battery in the heart
Intervention groups
Treatment group: providing Phonological awareness (PA) and Transcranial direct current stimulation
Control group: Providing PA and Sham Stimulation
Main outcome variables
Word, nonword reading and Phonological Awareness
General information
Reason for update
Acronym
TDCS, PA
IRCT registration information
IRCT registration number:IRCT20201211049676N1
Registration date:2021-04-20, 1400/01/31
Registration timing:registered_while_recruiting
Last update:2021-04-20, 1400/01/31
Update count:0
Registration date
2021-04-20, 1400/01/31
Registrant information
Name
seyyedeh samaneh mirahadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3324 6018
Email address
saamaneh.milo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-30, 1399/10/10
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Phonological Awareness (PA), grapheme to phoneme knowledge treatments, and transcranial direct current stimulation (TDCS) on PA and reading skills in reading disabled students.
Public title
Effects of transcranial direct current stimulation and Phonological Awareness treatment in Dyslexia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
mental age commensurate with second to fifth grades
Non-verbal IQ higher than 80
having phonological dyslexia
Right handedness
Monolingualism (Persian)
Exclusion criteria:
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
28
More than 1 sample in each individual
Number of samples in each individual:
1
Each participants provides one sample
Randomization (investigator's opinion)
Randomized
Randomization description
In order to allocate randomly, the random blocks method with blocks 4 size will be used. According to the sample size of 32 that has been determined, 8 quadruple blocks will be produced using the online site (www.sealedenvelope.com). In order to apply concealment in the randomization process, unique codes will be used on the boxes that determine the type of intervention, and the mentioned code is also generated by the software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study undermentioned persons will be blind:
- Evaluator relative to pre and post-intervention assessments
- Therapist relative to Sham-active intervention execution (Sham: The placebo state in which the device electrodes are placed on the scalp to create a placebo effect, but no current is sent to the brain. Active: Anodal stimulation mode (positively charged) where the electrodes are on the scalp and a current of 1mili Amper (mA) is directed to the brain for 20 minutes.
- Participants relative to receiving Sham-active intervention execution
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No.14, 18 metri Ave,
City
Ardabil
Province
Ardabil
Postal code
5619656435
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.IUMS.REC.1399.1377
Health conditions studied
1
Description of health condition studied
Dyslexia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
word reading (high frequency, average frequency, low frequency)
Timepoint
Baseline, end of the fifth treatment session, end of the tenth treatment session, end of the final treatment session, one month later (follow up)
Method of measurement
Reading test
2
Description
Phonological awareness
Timepoint
Baseline, end of the fifth treatment session, end of the tenth treatment session, end of the final treatment session, one month later (follow up)