Designing and producing an evaluation and rehabilitation program based on the fundumental frequency and the vocal tract length and investigating its effect on speech recognition in noise of children with cochlear implants
Determining the skill of cochlear implant user children in distinguishing the difference between F0 and VTL cues by making a test make a rehabilitation intervention program based on the difference between F0 and VTL cues to improve speech recognition in noise for cochlear implant user children
Design
The present study is an interventional clinical trial of a randomized blind strain using the block method on 24 patients, which will be used random allocation software for random allocation .
Settings and conduct
Cochlear implant users who refer to the audiology clinic of Iran University of Medical Sciences Faculty of Rehabilitation which have inclusion criteria participate in this study. they are randomly divided into control and intervention groups by blocking method. Blinding is such that the participants do not know which study group they are in. Initial evaluations and vocal cue discrimination evaluation will be done for both groups, then the intervention group will receive the rehabilitation program designed based on the vocal cues, and after the rehabilitation sessions, pre-rehabilitation evaluations for both control and intervention groups will be repeated and results will be compared
Participants/Inclusion and exclusion criteria
Children aged 10 to 12 years with unilateral cochlear implantation before 4 years of age with a history of using hearing aids before implantation are the inclusion criteria. Having neurological disorders is a criterion for non-entry
Intervention groups
Intervention group: cochlear implant users who received rehabilitation training
Control group: cochlear implant users without rehabilitation training
Main outcome variables
discrimination the difference in the of the vocal tract length; discrimination difference in fundamental frequency; speech recognition in noise
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220206053952N3
Registration date:2023-04-30, 1402/02/10
Registration timing:registered_while_recruiting
Last update:2023-04-30, 1402/02/10
Update count:0
Registration date
2023-04-30, 1402/02/10
Registrant information
Name
Farnoush Jarollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 0541
Email address
jarollahi.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2024-02-15, 1402/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and producing an evaluation and rehabilitation program based on the fundumental frequency and the vocal tract length and investigating its effect on speech recognition in noise of children with cochlear implants
Public title
Investigating the efficacy of rehabilitation based on vocal cues on speech recognition in noise in children with cochlear implants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
10 to 12 years old
Unilateral cochlear implantation
Performing cochlear implant surgery before 4 years old
Having normal general health
No history of neurological disorders
No history of psychological disorders
Absence of external ear l anomalies
Normal middle ear function
Onset of severe to profound hearing loss before 2 years old
History of hearing aid use before implantation
Participation in auditory training classes at least 6 months before implantation
Monolingual
Daily use of standard Persian language
Exclusion criteria:
Reluctance to continue participating in the study at any stage
Age
From 10 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the blocking method is used in the form of 6 quadruple blocks with individual units for random allocation between two control and intervention groups. Random allocation software will be used for random allocation. In order to hide the random allocation, non-transparent sealed envelopes will be used for this purpose, a number of envelopes will be prepared and each of the random sequences created will be recorded on a card and the cards will be placed in the envelope in order to preserve, random sequence is done on the outer surface of the envelopes, numbering is done in the same order, and finally the lid of the envelopes is glued and placed inside the box, then according to the number of each participant envelope will be given to her and her group will be determined
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Iran University of Medical Sciences
Street address
Hemat Highway next to Milad Tower of Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-08-22, 1401/05/31
Ethics committee reference number
IR.IUMS.REC.1401.750
Health conditions studied
1
Description of health condition studied
cochlear implant
ICD-10 code
Z96.21
ICD-10 code description
Cochlear implant status
Primary outcomes
1
Description
Improved discrimination of VTL∆ and F0∆ vocal cues
Timepoint
After ten sessions of rehabilitation based on vocal cues
Method of measurement
VTL∆ vocal cue discrimination test, F0∆ vocal cue discrimination test
2
Description
Improvement of speech in noise perception
Timepoint
After ten sessions of rehabilitation based on vocal cues
Method of measurement
PARVIN speech in noise perception test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention in this study is a new rehabilitation program based on vocal cue discrimination. This program is designed to investigate the effect of improvement speech recognition in noise by vocal cue discrimination exercises. Rehabilitation exercises are divided into 3 general categories of gender voice discrimination, ΔVTL discrimination and ΔF0 discrimination and will be performed in an free field at a comfortable listening level. The easiest exercise is gender voice discrimination. In this case, the training material will be recorded by a female speaker. Then the amount of VTL changes in the ratios of 0.84, 0.92, 0.96, 0.98, 0.21, 04.1, 08.1 and 1.16. The amount of F0 will be decreased in 3, 6, 9, and 12 semitones (producing a male voice) and in 3, 6, and 9 semitones will be increased (producing a thin female voice). the patient should show on monitor that heard the man or the woman. The next exercise in gender voice discrimination is that the items will be recorded once with a male speaker and changes will be applied to reduce the VTL in the ratios of 0.84, 0.92, 0.96, 0.98. Then the items (two consecutive monosyllabic words) with ΔVTL are presented to the individual and the individual is asked to determine whether the first voice or the second voice was spoken by the female speaker (because the changes were towards the female voice), the same exercise with increasing F0 will be presented, that is, items (two consecutive monosyllabic words) with ΔF0 of 3, 6, 9 and 12 semitones will be presented to the individual and the individual will be asked to identify the first voice or the second voice by the female speaker (because the changes were towards the female voice Is),The same exercise will be recorded once with a female speaker, and this time the changes will be in the direction of increasing VTL or decreasing F0 separately, and the person will be asked to specify whether the first or second voice was played by the male speaker. It will be marked on the monitor. The next step is ΔVTL and ΔF0 differentiation exercises, which will be divided into 3 groups of two-syllable, monosyllabic and consonant-vowel words. The exercises in this stage include two modes of distinguishing between two options, and distinguishing between three options. Fist practice of ΔVTL discrimination, is presented to the person in the form of two options that differ or are the same in VTL, and the person must specify whether he heard two options that are the same or different, and the examiner marks on the monitor. The second mode is the distinction between 3 options, where three identical two-syllable or monosyllabic or consonant-vowel words are presented consecutively, one of which has a different VTL from the other two, the person must determine which presentation was different, and the examiner marks on monitor . ΔF0 discrimination exercises will be designed and implemented like ΔVTL exercises. In each of the training stages, after the child's response, visual feedback will appear for him. The optimal situation for auditory perception learning includes active and repeated listening during consecutive training sessions that It is done in a short period of time and considering that long-term rehabilitation is not very suitable for clinical work. Therefore, 40-minute exercises (two 20-minute sessions with a 10-minute break in one day) will be performed twice a week for 10 sessions.
Category
Rehabilitation
2
Description
Control group: These people do not receive the rehabilitation program developed in this study
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Mahya Sharifinik
Street address
Faculty of Rehabilitation Sciences, Mader Square, Shah Nazari Street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 2059
Email
rehabiums@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hosein Keyvani
Street address
Hemmat Highway, Near Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
keyvani.h@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
Mahya Sharifinik
Position
PhD. Candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology Department, Rehabilitation Science School of Iran University of Medical Sciences , Madadkaran St., Shah Nazari St., Madar Sq