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IRCT20220206053952N3 IRCT 2023-04-30 Iran University of Medical Sciences Investigating the efficacy of rehabilitation based on vocal cues on speech recognition in noise in children with cochlear implants 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 2023-03-06 anticipated 24 Complete https://irct.ir/trial/68039 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A cochlear implant. Intervention 1: 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. Intervention 2: Control group: These people do not receive the rehabilitation program developed in this study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It would be specified by the study supervisor.
public Mahya Sharifinik
Audiology Department, Rehabilitation Science School of Iran University of Medical Sciences , Madadkaran St., Shah Nazari St., Madar Sq
Tehran Iran (Islamic Republic of) ۱۳۴۸۷۱۵۴۵۹ 0212222096 mahyasharifinik@gmail.com Iran University of Medical Sciences scientific Farnoosh Jarolahi
Faculty of Rehabilitation Sciences, Madadkaran Str., Shahnazari Ave., Madar Sqr., Mirdamad Blvd.
Tehran Iran (Islamic Republic of) ۱۳۴۸۷۱۵۴۵۹ 0212222096 jarollahi.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 10 years 12 years Both Reluctance to continue participating in the study at any stage Z96.21 Cochlear implant status Rehabilitation Rehabilitation 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. Control group: These people do not receive the rehabilitation program developed in this study 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. 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. Iran University of Medical Sciences Approved 2022-08-22 Research Ethics Committee of Iran University of Medical Sciences Hemat Highway next to Milad Tower of Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)