NCT04691830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

December 28, 2020

Last Update Submit

December 30, 2020

Conditions

Keywords

Hearing impairmentProsodySpeech rehabilitationCochlear implant

Outcome Measures

Primary Outcomes (8)

  • 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.

    baseline and 3 months

  • change in prosodic skill assessment protocol mean frequency measures

    a quantitative tool that evaluates mean frequency value of recorded utterances in hertz

    baseline and 3 months

  • change in prosodic skill assessment protocol mean duration measures

    a quantitative tool that evaluates mean duration of recorded utterances in msec

    baseline and 3 months

  • change in prosodic skill assessment protocol mean energy measures

    a quantitative tool that evaluates mean energy of recorded utterances in dB

    baseline and 3 months

  • 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

    baseline and 3 months

  • Change in Arabic prosodic assessment tool frequency measures

    a quantitative tool that evaluates frequency values of recorded utterances in hertz

    baseline and 3 months

  • Change in Arabic prosodic assessment tool duration measures

    a quantitative tool that evaluates duration of recorded utterances in msec

    baseline and 3 months

  • Change in Arabic prosodic assessment tool energy measures

    a quantitative tool that evaluates energy of recorded utterances in dB

    baseline and 3 months

Secondary Outcomes (2)

  • change in Arabic language test scores

    baseline and 3 months

  • change in values of Stanford Binet scale

    baseline and 3 months

Study Arms (4)

group IA

EXPERIMENTAL

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

Behavioral: Prosody treatment programBehavioral: Traditional auditory and language rehabilitation

group IB

ACTIVE COMPARATOR

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.

Behavioral: Traditional auditory and language rehabilitation

group IIA

EXPERIMENTAL

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

Behavioral: Prosody treatment programBehavioral: Traditional auditory and language rehabilitation

group IIB

ACTIVE COMPARATOR

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.

Behavioral: Traditional auditory and language rehabilitation

Interventions

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.

group IAgroup IIA

Auditory rehabilitation therapy included activities targeting auditory skills: sound detection, discrimination, identification and auditory comprehension. Language rehabilitation targeted improving semantics, syntax, pragmatics and phonology.

group IAgroup IBgroup IIAgroup IIB

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University, Faculty of Medicine

Alexandria, 21131, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ossama A Sobhy, PhD

    Alexandria University

    PRINCIPAL INVESTIGATOR
  • Rania M Abdou, PhD

    Alexandria University

    STUDY CHAIR
  • Nesrine H Hammouda, PhD

    Alexandria University

    STUDY DIRECTOR
  • Sara M Ibrahim, Master's

    Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Demonstrator of phoniatrics

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 31, 2020

Study Start

February 19, 2019

Primary Completion

February 16, 2020

Study Completion

February 16, 2020

Last Updated

December 31, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations