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Adaptation of a Rehabilitation Program for Prosody and Its Application on Egyptian Hearing Impaired Children

Primary Purpose

Hearing Impaired Children

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Prosody treatment program
Traditional auditory and language rehabilitation
Sponsored by
Sara Magdy Ibrahim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Impaired Children focused on measuring Hearing impairment, Prosody, Speech rehabilitation, Cochlear implant

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hearing impaired children of both sexes, in the preschool age (from 3 to 6 years), and school age (6 to 18 years).
  • Children using auditory verbal communication.
  • Children with moderately severe or severe up to profound sensorineural hearing loss in unaided conditions, fitted with hearing aids or cochlear implant devices with good benefit (aided hearing threshold less than 40 dB across all frequencies).

Exclusion Criteria:

  • Children with intellectual disability.
  • Children with brain damage.
  • Children with additional sensory deprivation (impaired vision).
  • Psychiatric problems (example; ASD).
  • Motor speech disorders (example: apraxia, dysarthria).

Sites / Locations

  • Alexandria University, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

group IA

group IB

group IIA

group IIB

Arm Description

Preschool cases group who received the proposed "prosody treatment program" in addition to the traditional auditory and language rehabilitation therapy.

preschool control group who received the traditional auditory and language rehabilitation therapy without the prosody rehabilitation program. This was considered the preschool age control group.

School age cases group who received the proposed "prosody treatment program" in addition to the traditional auditory and language rehabilitation therapy.

School age control group who received the traditional auditory and language rehabilitation therapy without the prosody rehabilitation program. This was considered the school age control group.

Outcomes

Primary Outcome Measures

change in prosodic skill assessment protocol subjective measures
a quantitative test that evaluates ten prosodic skills, each skill is given a subjective score from 0 to 4 (4 is the best score) with a total score of 40.
change in prosodic skill assessment protocol mean frequency measures
a quantitative tool that evaluates mean frequency value of recorded utterances in hertz
change in prosodic skill assessment protocol mean duration measures
a quantitative tool that evaluates mean duration of recorded utterances in msec
change in prosodic skill assessment protocol mean energy measures
a quantitative tool that evaluates mean energy of recorded utterances in dB
Change in Arabic prosodic assessment tool subjective ratings
a qualitative tool that rates prosodic skills of recorded utterances as either (A) Appropriate or (I) Inappropriate
Change in Arabic prosodic assessment tool frequency measures
a quantitative tool that evaluates frequency values of recorded utterances in hertz
Change in Arabic prosodic assessment tool duration measures
a quantitative tool that evaluates duration of recorded utterances in msec
Change in Arabic prosodic assessment tool energy measures
a quantitative tool that evaluates energy of recorded utterances in dB

Secondary Outcome Measures

change in Arabic language test scores
a quantitative too that evaluates language skills, raw scores are converted into language age equivalent scores
change in values of Stanford Binet scale
a quantitative tool that evaluates intelligence quotient

Full Information

First Posted
December 28, 2020
Last Updated
December 30, 2020
Sponsor
Sara Magdy Ibrahim
Collaborators
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04691830
Brief Title
Adaptation of a Rehabilitation Program for Prosody and Its Application on Egyptian Hearing Impaired Children
Official Title
Adaptation of a Rehabilitation Program for Prosody and Its Application on Egyptian Hearing Impaired Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
February 16, 2020 (Actual)
Study Completion Date
February 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Magdy Ibrahim
Collaborators
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impaired Children
Keywords
Hearing impairment, Prosody, Speech rehabilitation, Cochlear implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a comparative intervention study comparing the effect of prosodic rehabilitation in addition to the traditional language and auditory training on prosodic skills of hearing impaired children in comparison to traditional language and auditory rehabilitation alone.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group IA
Arm Type
Experimental
Arm Description
Preschool cases group who received the proposed "prosody treatment program" in addition to the traditional auditory and language rehabilitation therapy.
Arm Title
group IB
Arm Type
Active Comparator
Arm Description
preschool control group who received the traditional auditory and language rehabilitation therapy without the prosody rehabilitation program. This was considered the preschool age control group.
Arm Title
group IIA
Arm Type
Experimental
Arm Description
School age cases group who received the proposed "prosody treatment program" in addition to the traditional auditory and language rehabilitation therapy.
Arm Title
group IIB
Arm Type
Active Comparator
Arm Description
School age control group who received the traditional auditory and language rehabilitation therapy without the prosody rehabilitation program. This was considered the school age control group.
Intervention Type
Behavioral
Intervention Name(s)
Prosody treatment program
Intervention Description
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 incorporates the principles of validated prosodic rehabilitation strategies such as Dynamic Temporal and Tactile Cueing (DTTC), Melodic Intonation Therapy, Lee Silverman Voice Treatment in addition to expert professional practice. 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. The program is divided into two sections according to the age into preschool section and school age section.
Intervention Type
Behavioral
Intervention Name(s)
Traditional auditory and language rehabilitation
Intervention Description
Auditory rehabilitation therapy included activities targeting auditory skills: sound detection, discrimination, identification and auditory comprehension. Language rehabilitation targeted improving semantics, syntax, pragmatics and phonology.
Primary Outcome Measure Information:
Title
change in prosodic skill assessment protocol subjective measures
Description
a quantitative test that evaluates ten prosodic skills, each skill is given a subjective score from 0 to 4 (4 is the best score) with a total score of 40.
Time Frame
baseline and 3 months
Title
change in prosodic skill assessment protocol mean frequency measures
Description
a quantitative tool that evaluates mean frequency value of recorded utterances in hertz
Time Frame
baseline and 3 months
Title
change in prosodic skill assessment protocol mean duration measures
Description
a quantitative tool that evaluates mean duration of recorded utterances in msec
Time Frame
baseline and 3 months
Title
change in prosodic skill assessment protocol mean energy measures
Description
a quantitative tool that evaluates mean energy of recorded utterances in dB
Time Frame
baseline and 3 months
Title
Change in Arabic prosodic assessment tool subjective ratings
Description
a qualitative tool that rates prosodic skills of recorded utterances as either (A) Appropriate or (I) Inappropriate
Time Frame
baseline and 3 months
Title
Change in Arabic prosodic assessment tool frequency measures
Description
a quantitative tool that evaluates frequency values of recorded utterances in hertz
Time Frame
baseline and 3 months
Title
Change in Arabic prosodic assessment tool duration measures
Description
a quantitative tool that evaluates duration of recorded utterances in msec
Time Frame
baseline and 3 months
Title
Change in Arabic prosodic assessment tool energy measures
Description
a quantitative tool that evaluates energy of recorded utterances in dB
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
change in Arabic language test scores
Description
a quantitative too that evaluates language skills, raw scores are converted into language age equivalent scores
Time Frame
baseline and 3 months
Title
change in values of Stanford Binet scale
Description
a quantitative tool that evaluates intelligence quotient
Time Frame
baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hearing impaired children of both sexes, in the preschool age (from 3 to 6 years), and school age (6 to 18 years). Children using auditory verbal communication. Children with moderately severe or severe up to profound sensorineural hearing loss in unaided conditions, fitted with hearing aids or cochlear implant devices with good benefit (aided hearing threshold less than 40 dB across all frequencies). Exclusion Criteria: Children with intellectual disability. Children with brain damage. Children with additional sensory deprivation (impaired vision). Psychiatric problems (example; ASD). Motor speech disorders (example: apraxia, dysarthria).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ossama A Sobhy, PhD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rania M Abdou, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nesrine H Hammouda, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sara M Ibrahim, Master's
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Alexandria University, Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34289481
Citation
Sobhy OA, Abdou RM, Ibrahim SM, Hamouda NH. Effects of Prosody Rehabilitation on Acoustic Analysis of Prosodic Features in Hearing-Impaired Children: A Randomized Controlled Trial. Folia Phoniatr Logop. 2022;74(1):29-45. doi: 10.1159/000516979. Epub 2021 Jul 21.
Results Reference
derived

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Adaptation of a Rehabilitation Program for Prosody and Its Application on Egyptian Hearing Impaired Children

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