New Therapeutical Perspectives in Cases of Phonological Disorders

Speech Sound Disorders Clinical Trial

Official title:

New Therapeutical Perspectives in Cases of Phonological Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935062
• Other study ID #: 28053914.1.0000.5346
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: February 2018

Study information

• Verified date: November 2019
• Source: Universidade Federal de Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Articulation Disorders
• Disease
• Speech Sound Disorder
• Speech Sound Disorders

Intervention

Behavioral:
• Traditional Phonological Therapy
Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words.
• Software Phonological Therapy- SIFALA
The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds.
• Placebo Therapy
No intervention to improve speech.

Locations

Country	Name	City	State
Brazil	Federal University of Santa Maria	Santa Maria	Rio Grande Do Sul
Brazil	Universidade Federal de Santa Maria- campus Camobi e centro- Floriano Peixoto 1709.	Santa Maria	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 weeks
Primary	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	10 weeks.