Investigation into efficacy of an auditory training program based on interaural interaction in children with specific learning disorder
Design
Clinical trial with control group,Participants are selected non- randomly for each group
Settings and conduct
The intervention part of this study includes an auditory training program ( designing, building and implementation are doing in this study). The participants are learning disorder children (7 to 12 years old), in the Isfahan city learning disorder centers and in two intervention and control groups.The intervention group will use the auditory training program for 3 months.
Participants/Inclusion and exclusion criteria
Age range between 7-12 years old ,Normal auditory thresholds (<20dB HL) within 250 to 8000Hz frequency range, Definite diagnosis of specific learning disorder by psychologist based on DSM-5 Criteria, Teacher or parents report about some problem in sound localization and speech perception in noise- Abnormal MLD Test result ( MLD< 7dB) Abnormal PARWIN test result.
/Music training or participating in the other rehabilitative programs, History of ear disease
Intervention groups
Intervention includes an auditory training program designed based on binaural Processing in brainstem level. People will be divided in two intervention and control groups non-randomly.
Main outcome variables
MLD and Persian auditory recognition of words-in-noise (PARWIN) are the main variables of this survey.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210522051359N1
Registration date:2021-07-04, 1400/04/13
Registration timing:prospective
Last update:2021-07-04, 1400/04/13
Update count:0
Registration date
2021-07-04, 1400/04/13
Registrant information
Name
Marziyeh Moallemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 0541
Email address
marziyehmoallemi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-12-11, 1400/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation into efficacy of an auditory training program based on interaural interaction in children with specific learning disorder
Public title
Effect of central auditory training on learning disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
-Age range between 7-12 years old ,
Normal auditory thresholds (<20dB HL) within 250 to 8000Hz frequency range
Hearing in both ears symmetrically ( difference thresholds <10 dB)
Definite diagnosis of specific learning disorder by psychologist based on DSM-5 Criteria (normal vision, minimum cognitive and intelligence skills are among this criteria)
Right-handedness (using Edinburgh handedness inventory)
Word recognition score in quiet ≥ 90%
Being monolingual ( Farsi as a native language)
Teacher or parents report about some problem in sound localization and speech perception in noise-
Abnormal MLD Test result ( MLD < 7dB)
Abnormal PARWIN test result
Exclusion criteria:
Music training
Participating in the other rehabilitative programs
History of neurological and psychological disorders
History of any ear disease
Taking medication
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
There is an intervention and two groups...one group receive rehabilitation and the other group (control group) don't receive any intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University Campus, Hemmat freeway, next to Milad tower, Tehran,
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-06-16, 1399/03/27
Ethics committee reference number
IR.IUMS.REC.1399.300
Health conditions studied
1
Description of health condition studied
Learning disorder
ICD-10 code
F81.9
ICD-10 code description
Developmental disorder of scholastic skills, unspecified
Primary outcomes
1
Description
Masking level difference (MLD) and Persian auditory recognition of words-in-noise
Timepoint
Before, immediately after intervention, and 45 days after the completion of intervention
Method of measurement
MLD test and Persian auditory recognition of words-in-noise (PARWIN) test
Secondary outcomes
1
Description
Recognition of Persion randomized dichotic digits and Auditory communication improvement
Timepoint
Before, immediately after completing intervention, and 45 days after the completion of intervention
Method of measurement
PRDDT test and questionnaire
Intervention groups
1
Description
Intervention group are children with learning disorder in 7 -12 years old range who are candidates for receiving an auditory training program based on binaural interaction. They will use the designed rehabilitation program for 3 months (36 sessions), and will be assessed by behavioural tests before and after the intervention. The mentioned program is designated based on auditory brainstem function and is usable as an Application. Five important auditory function are included in the program.
Category
Rehabilitation
2
Description
Control group: Children with Learning disorder in 7 -12 years old range with no intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan centers for Learning disorder
Full name of responsible person
Marziyeh Moallemi
Street address
No 15, Artesh Ave
City
Isfahan
Province
Isfehan
Postal code
1545913487
Phone
+98 21 2225 0541
Email
marziyehmoallemi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Abbas Motevallian
Street address
near Milad Tower, Shahid Hemmat Highway. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marziyeh Moallemi
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology Department, Faculty of Rehabilitative, Shah Nazari Ave, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8951
Email
marziyehmoallemi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marziyeh Moallemi
Position
ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology Department, Faculty of Rehabilitative, Shah Nazari Ave, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8951
Email
marziyehmoallemi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marziyeh Moallemi
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology Department, Faculty of Rehabilitative, Shah Nazari Ave, Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8951
Email
marziyehmoallemi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available