The objective of this research is to exercise (train) working memory (WM) in children with cochlear implant (CI). The study populations were 7-10 years children with CI in Fars CI center entered the study by convenience sampling. Inclusion criteria are: 1)7-10 years old, 2) received CI device for minimum 1 year 3) monolingual (Persian speakers) 4)no cerebral palsy (CP) or central auditory processing disorders (CAPD) based on their medical record, 5)Normal IQ and exclusion criteria consist of 1)low cooperation 2)no attending minimum 10 sessions.
The tasks will be used in this study are Forward Digit Span (FDS) and Backward Digit Span (BDS) from the Persian version of WISC-IV, Non-Word Repetition test (NWR) and sentence repetition test. This research will be conducted in several stages explained for children and their parents. In the first stage, FDS, BDS, NWR and sentence repetition test will be performed by an expert was blinded to the study. Then children will attend a pretraining visit to familiar with the software. At the second stage, for training WM they will follow 16 sessions (at least 10 sessions), each session 45 minutes twice per week. Working memory training software is a Persian computer game compatible with its English version of Cogmed Company. At the end of the 16 sessions, all the initial tasks (FDS, BDS, NWR and sentence repetition test) will be repeated and data will be registered for comparing pre and post training.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072623348N1
Registration date:2016-04-13, 1395/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-13, 1395/01/25
Registrant information
Name
Afsaneh Doosti
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
afsanehdoosti@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Shiraz University of Medical Sciences
Expected recruitment start date
2016-01-24, 1394/11/04
Expected recruitment end date
2016-03-17, 1394/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the effect of exercise on working memory in 7-10 years cochlear implanted children
Public title
Effect of exercise on memory in cochlear implanted children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 7-10 years old who received CI device for minimum 1 year, normal IQ , no central auditory processing disorders (based on audiologist diagnosis), Cooperation, monolingual (Persian), right handedness based on Edinburgh criteria no attitude disorder (hyperactivity, attention deficit) based on medical file.
Exclusion criteria: No cooperation (parents or children), do not complete any training sessions
Age
From 7 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single 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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences building, front of Felestin St. Zand St. Shiraz
City
Shiraz
Postal code
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.SUMS.REC.1394.194
Health conditions studied
1
Description of health condition studied
cochlear implant
ICD-10 code
Z96.2
ICD-10 code description
Presence of audiological implants (functional)
Primary outcomes
1
Description
Digit memory
Timepoint
before and immediately after training session with working memory software (minimum 10 sessions)
Method of measurement
Wechsler Intelligence Scale for Children
Secondary outcomes
1
Description
non-word repetition & sentence repetition
Timepoint
before and immediately after training session with working memory software (minimum 10 sessions)
Method of measurement
non-word repetition test & sentence repetition test
Intervention groups
1
Description
In this study, cochlear implanted child will be trained by Working memory training software is compatible with its English version made by the Cogmed Company. Treatment consists of 16 training sessions (45 minutes).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fars cochlear implantation center
Full name of responsible person
Seyed Basir Hashemi (Professor in Otolaryngology and Fellowship in Ear Diseases and Cochlear Implant
Street address
Khalili Hospital, Khalili St. Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi, Vice-Chancellor for Research and Technology Affairs
Street address
Vice chancellor of research, Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Afsaneh Doosti
Position
Assistant professor
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation Sciences, Chamran Blv, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
afsanehdoosti@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Position
Professor of Otolaryngology
Other areas of specialty/work
Street address
Khalili Hospital, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3629 1470
Fax
Email
hashemib@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Afsaneh Doosti
Position
PhD /Assistant Professor
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation Sciences, Chamran Blv
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
afsanehdoosti@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)