Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04691830 |
Other study ID # |
0105832 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 19, 2019 |
Est. completion date |
February 16, 2020 |
Study information
Verified date |
December 2020 |
Source |
Alexandria University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Prosody is the melody and rhythm of speech, it is used to refer to the supra segmental
aspects of speech including pitch, loudness and duration. Variations in these features
achieve different prosodic functions and are perceived by the listener as meaningful changes.
The role of prosody in language acquisition and effective communication is documented in
research. Nevertheless, prosodic intervention in children with hearing impairment received
less attention compared to other speech and language areas.
The aim of this study is to adapt the "prosody treatment program", an evidence based
rehabilitation program, and to detect the efficacy of its activities in improving the
prosodic skills of Egyptian hearing impaired children.
The "prosody treatment program" is an evidence-based practice targeting receptive and
expressive prosodic skills in addition to speech production, intelligibility, pragmatics and
phonology. The program is applied using a systematic approach of providing cues following the
principles adapted from dynamic temporal and tactile cueing (DTTC) for speech motor learning
to help accelerate the child's learning of the prosodic skills targeted in this program. The
program was translated to Arabic and adapted to be suitable for the Egyptian children.
Description:
Prosody has an important role in several areas of communicative functions including :
grammatical, pragmatic, affective and/or indexical functions. Prosodic abnormalities extend
across a wide range of communication disorders. Intact functioning auditory system has a
fundamental role in language acquisition and development. Children receive the speech of
others as a source of linguistic input which is considered their target and they gradually
modify their productions using their own auditory feedback to reach the target utterance.
Hearing impairment early in life deprives the child of the source of their linguistic input
affecting various aspects of speech and language development. Speech production of the
hearing impaired is characterized by various segmental and suprasegmental errors.
Case studies show that interventions targeting prosody can modify prosody in young children
with speech and language impairments. Multiple problems of prosody , language, speech and
voice are found in individuals with prosodic impairments ,therefore it is challenging to
develop treatment protocols addressing prosody .There are only few published interventions
targeting prosody .
Due to lack of well structured comprehensive Arabic programs targeting prosody , this work
was dedicated towards adaptation of "prosody treatment program" a remediation program
targeting receptive and expressive prosodic skills and its application on hearing impaired
children .The proposed program targets two levels: preschool and school aged children.
The aim of this work was to adapt the "prosody treatment program" program and apply its
activities in cases of hearing impairment to detect its efficacy in improvement of prosodic
skills in Egyptian hearing impaired children fitted with hearing aids or cochlear implant
devices.
This study was conducted on 55 children with hearing impairment attending the Unit of
Phoniatrics , in the outpatient clinic of Alexandria Main University hospital. Sample size
was calculated using two proportions power analysis in NCSS and PASS program a minimum sample
size required to detect the efficacy of the "prosody treatment program" in improvement of
prosodic skills of Egyptian hearing impaired children and to detect a difference of 0.5 that
achieve 80% power with a target significance level at 5%.
The proposed program is based on " prosody treatment program", a program targeting receptive
and expressive prosodic skills. It includes activities targeting loudness , word stress
,syllable stress ,pitch ,question inflections ,emotions ,sarcasm ,rhythm ,chunking, and
speaking rate . The program was adapted in order to be appropriate to the Arabic language and
to the Egyptian children. The program was applied using a systematic approach of providing
cues to help accelerate the child's learning of the prosodic skills targeted in the program.
Cues are adapted from the Dynamic Temporal and Tactile Cueing (DTTC) for Speech Motor
Learning hierarchy. It aims at improving motor planning, and programming speech processing as
speech and language acquisition progresses.
The program is divided into two sections according to the age into preschool section and
school age section.
A pilot study was conducted on 8 cases with hearing impairment attending the phoniatrics unit
to check the suitability of the rehabilitation program and modify the needed items.
All subjects met the specified inclusion and exclusion criteria and were assessed by the
specified protocol of assessment to evaluate prosodic skills, language skills and cognitive
abilities before and after intervention.
Data were analyzed using IBM SPSS software package version 20.0. (Armonk, NY: IBM Corp).
Qualitative data were described using number and percent. Chi square test was used for
comparison of qualitative variables in two groups, Fisher exact test was used to compare
qualitative variables when 50% of cell value was less than 5. McNemar test was used to
compare nominal variables before and after intervention. The Kolmogorov-Smirnov test was used
to verify the normality of distribution. Quantitative data were described using mean,
standard deviation and IQR. Test of significance used included different tests. t test to
compare between different means. Mann Whitney U test to compare non normally distributed
quantitative variables in two different groups. Paired t test for comparison of normally
distributed variables in matched pairs. Wilcoxon signed rank test for pre-post comparison in
non-normally distributed quantitative variables. Kappa coefficient was used to assess level
of agreement between two raters. Significance of the obtained results was judged at the 5%
level.