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Completed

NCT Number: NCT02935062

New Therapeutical Perspectives in Cases of Phonological Disorders

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.

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Key information

Conditions

Speech Sound Disorders Behavior Communication Communication Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Speech Sound Disorder Verbal Behavior

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Phonological Therapy

Behavioral

Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words.

Software Phonological Therapy- SIFALA

Behavioral

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

Behavioral

No intervention to improve speech.

Primary outcomes

  1. Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument

    Time frame: 10 weeks

    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.

  2. P300- Long-latency Auditory Evoked Potential

    Time frame: 10 weeks.

    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

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Maria

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2016
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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