Comparison of efficacy of focused language treatment and working memory training on some of the components of grammar in children with cochlear implant
The aim of this study is to compare the effectiveness of reinforcement of working memory and the language treatment on certain components of grammar of children are receiving cochlear implants.The study included:The intervention group1:grammar intervention done on it.Intervention group2: intervention is done on the working memory and control group who continue their routine sessions of speech therapy.The sample is consisted of 15 subjects (each group consisted of 5 patients who were randomly divided into groups by closed envelope). This study is a single-center, randomized and blinded. Participants between 5 and 8 years of age and have at least two years of experience using cochlear implants.Working memory intervention and grammar intervention, done in 5 weeks. During the five weeks of the child and family once a week to come therapist ,this session includes evaluating aspects taught in the previous session, treatment and education family for workouts during the week.The family is responsible for 30 to 45 minutes a day 5 days a week, practice with the child at home.Primary and secondary outcome variables (grammar and memory) will be measured before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071726083N1
Registration date:2016-07-17, 1395/04/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-17, 1395/04/27
Registrant information
Name
soodeh khoramian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
mkhoramian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of focused language treatment and working memory training on some of the components of grammar in children with cochlear implant
Public title
efficacy of focused language treatment and working memory training on some of the components of grammar in children with cochlear implant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged between 5 to 8 years; They are congenital hearing loss; Two years have passed since the implants; Their language is Persian language; Based on test of language 50 have said,at least; Hearing loss is not caused by the syndrome;They have not Neuromusculardisorder;They have normal non-verbal; Unilateral cochlear implant; implant on the right ear; the child is right-handed; 22-channel nucleus prosthesis
Exclusion criteria:Child has other deficit with hearing loss; child is bilingual.
Age
From 5 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Parallel allocation; Randomized using sealed envelopes
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab Ave
City
Tehran
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.TUMS.REC.1394.1971
Health conditions studied
1
Description of health condition studied
hearing loss
ICD-10 code
H90.2
ICD-10 code description
Conductive hearing loss, unspecified
Primary outcomes
1
Description
Reception of Grammar
Timepoint
5 weeks
Method of measurement
Test of Language Development
Secondary outcomes
1
Description
working memory
Timepoint
5 weeks
Method of measurement
forward & backward digit span of WISC
Intervention groups
1
Description
Intervention group 1: language intervention for5 weeks (25 days) - each session is 30 to 45 minutes- Will be implemented in partnership with parents.Method of treatment in this group include modelling and focused stimulation on comprehension and expression grammar. Mothers will trained how to intervene by therapist.
Category
Rehabilitation
2
Description
working memory intervention for5 weeks (25 days)- each session is 30 to 45 minutes- Will be implemented in partnership with parents.method of memory enhancement is providing auditory stimuli such as the retrieval number, word, sentence. Mothers will trained how to intervene by therapist.
Category
Rehabilitation
3
Description
Control group: routine speech therapy they receive
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Alam Hospital
Full name of responsible person
Masoud Motasaddi zarandy
Street address
E.N.T department, Amiralam Hospital, Saadi ave. , Tehran, IRAN
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
tehran University of Medical sciences
Full name of responsible person
Masud Yunesian
Street address
Department of Environmental Health Engineering, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
tehran University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
soodeh khoramian
Position
master of Science
Other areas of specialty/work
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
1148965141
Phone
+98 21 7763 6042
Fax
+98 21 7753 4133
Email
khoramianslp@gmail.com
Web page address
http://rehab.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
zahra soleymani
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
1148965141
Phone
+98 21 7763 6042
Fax
+98 21 7753 4133
Email
soleymaniz@tums.ac.ir
Web page address
http://rehab.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
soodeh khoramian
Position
master of Science
Other areas of specialty/work
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
1148965141
Phone
+98 21 7763 6042
Fax
+98 21 7753 4133
Email
khoramianslp@gmail.com
Web page address
http://rehab.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)