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New Therapeutical Perspectives in Cases of Phonological Disorders

Primary Purpose

Speech Sound Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Traditional Phonological Therapy
Software Phonological Therapy- SIFALA
Placebo Therapy
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Speech Sound Disorders focused on measuring Speech, Speech Therapy, Speech Sound Disorders, Phonological Disorders, Auditory Perception

Eligibility Criteria

4 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Parents/guardians and child agree to participate and have signed the Informed Consent Form;
  • Have age between 4:0 to 8:11 (years:months);
  • Present diagnosis of phonological disorders;
  • Present hearing thresholds within the normal range

Exclusion Criteria:

  • Present neurological impairment, emotional and/or cognitive clearly diagnosed, or have complaint;
  • Present any degree of hearing loss is the type conductive, mixed or sensorineural, and middle ear disorders in time of selection, as well as having presented otitis complaints;
  • Present language impairment associated with speech sound disorder;
  • Present commitment in the stomatognathic system that can interfere in the speech production;
  • Have been received speech and language therapy before.

Sites / Locations

  • Universidade Federal de Santa Maria- campus Camobi e centro- Floriano Peixoto 1709.
  • Federal University of Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Traditional Phonological Therapy

Software Phonological Therapy- SIFALA

Placebo Therapy

Arm Description

This intervention will be intermediated by the traditional model cycles. This approach has the principle of treating the suppression of operant phonological processes in child's speech, from the awareness of sound-target characteristics operating in that phonological process.

This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments.

No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities.

Outcomes

Primary Outcome Measures

Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument
The percentage of correct consonants corresponds to the number of phonemes produced by the child, evaluated initially before starting treatment and at the end of treatment. The variable of this calculation is based on the percentage which is determined at what phonological level of disorder the child is at. It is expected that at the end of treatment the percentage of correct consonants will increase due to the therapy stimuli offered.
P300- Long-latency Auditory Evoked Potential
Electrophysiological evaluation of the auditory pathway through the protocol, Pretreatment and Post-treatment P300 waves were analyzed by the latency according to the parameters of MacPherson (1996). The electrophysiological protocol was performed before and after therapy. The marking of the waves was judged by specialist judges in the field of audiology. The variable that predicts P300 latency is quantified in milliseconds (ms

Secondary Outcome Measures

Full Information

First Posted
September 15, 2016
Last Updated
November 27, 2019
Sponsor
Universidade Federal de Santa Maria
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1. Study Identification

Unique Protocol Identification Number
NCT02935062
Brief Title
New Therapeutical Perspectives in Cases of Phonological Disorders
Official Title
New Therapeutical Perspectives in Cases of Phonological Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to verify phonological and auditory aspects of children submitted to traditional phonological therapy, phonological therapy using a software and placebo therapy in children with phonological disorders.
Detailed Description
The study will provide different therapeutic approaches for cases of phonological disorders, the classical approach would be mediated by Cycles Model, innovated approach is performed by means of an intervention speech software-SIFALA, there will still be the group that does not receive any of the proposals therapies that will be the placebo group.The study will provide 25 sessions for each group, with 30 minutes in each group. At the end of these sessions, the placebo group will receive one of the therapeutic approaches. With these three study groups, the investigators understand in what manner to obtain correct sounds is more effective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Sound Disorders
Keywords
Speech, Speech Therapy, Speech Sound Disorders, Phonological Disorders, Auditory Perception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Phonological Therapy
Arm Type
Active Comparator
Arm Description
This intervention will be intermediated by the traditional model cycles. This approach has the principle of treating the suppression of operant phonological processes in child's speech, from the awareness of sound-target characteristics operating in that phonological process.
Arm Title
Software Phonological Therapy- SIFALA
Arm Type
Experimental
Arm Description
This intervention will be intermediated by the software SIFALA. The software SIFALA, allows to select target segments using the Modelo de Estratos (second model Strata), based on the level segment of production and complexity of distinctive features, from the child's sound system analysis and planned generalizations. It also seeks the treatment of phonological disorders, by selection stimulus words in more favorable environments and playful activities with computer resource for the correct production of the target segment in the words stimulus, promoting the spread segments.
Arm Title
Placebo Therapy
Arm Type
Placebo Comparator
Arm Description
No interventional group. This group will be the sham group. The proposed activities will be fun games on the computer, there is no relationship with speech and it will be not emphasized the correct sound production, will only play activities.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Phonological Therapy
Intervention Description
Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words.
Intervention Type
Behavioral
Intervention Name(s)
Software Phonological Therapy- SIFALA
Intervention Description
The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds.
Intervention Type
Behavioral
Intervention Name(s)
Placebo Therapy
Intervention Description
No intervention to improve speech.
Primary Outcome Measure Information:
Title
Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument
Description
The percentage of correct consonants corresponds to the number of phonemes produced by the child, evaluated initially before starting treatment and at the end of treatment. The variable of this calculation is based on the percentage which is determined at what phonological level of disorder the child is at. It is expected that at the end of treatment the percentage of correct consonants will increase due to the therapy stimuli offered.
Time Frame
10 weeks
Title
P300- Long-latency Auditory Evoked Potential
Description
Electrophysiological evaluation of the auditory pathway through the protocol, Pretreatment and Post-treatment P300 waves were analyzed by the latency according to the parameters of MacPherson (1996). The electrophysiological protocol was performed before and after therapy. The marking of the waves was judged by specialist judges in the field of audiology. The variable that predicts P300 latency is quantified in milliseconds (ms
Time Frame
10 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parents/guardians and child agree to participate and have signed the Informed Consent Form; Have age between 4:0 to 8:11 (years:months); Present diagnosis of phonological disorders; Present hearing thresholds within the normal range Exclusion Criteria: Present neurological impairment, emotional and/or cognitive clearly diagnosed, or have complaint; Present any degree of hearing loss is the type conductive, mixed or sensorineural, and middle ear disorders in time of selection, as well as having presented otitis complaints; Present language impairment associated with speech sound disorder; Present commitment in the stomatognathic system that can interfere in the speech production; Have been received speech and language therapy before.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia Keske-Soares, PhD
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de Santa Maria- campus Camobi e centro- Floriano Peixoto 1709.
City
Santa Maria
State/Province
Rio Grande Do Sul
ZIP/Postal Code
97015-372
Country
Brazil
Facility Name
Federal University of Santa Maria
City
Santa Maria
State/Province
Rio Grande Do Sul
ZIP/Postal Code
97060-500
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The plan to make the individual data available is in accordance with the criteria adopted in the research and the research ethics committee of the educational institution, which developed the study. The results, placed on the platform of this randomized clinical trial, can be used by other researchers.
IPD Sharing Time Frame
Results were exposed for three years
IPD Sharing Access Criteria
Researchers with access to Clinical Trials and those who wish to contact the responsible researcher.

Learn more about this trial

New Therapeutical Perspectives in Cases of Phonological Disorders

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