New Therapeutical Perspectives in Cases of Phonological Disorders

NCT02935062 | Completed Results DMC

• 1 other identifier: 28053914.1.0000.5346
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Speech Sound Disorders

Keywords

Speech; Speech Therapy; Speech Sound Disorders; Phonological Disorders; Auditory Perception

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

Study Arms (3)

Traditional Phonological Therapy

ACTIVE COMPARATOR

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.

Behavioral: Traditional Phonological Therapy

Software Phonological Therapy- SIFALA

EXPERIMENTAL

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.

Behavioral: Software Phonological Therapy- SIFALA

Placebo Therapy

PLACEBO COMPARATOR

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.

Behavioral: Placebo Therapy

Interventions

Traditional Phonological Therapy BEHAVIORAL

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

Traditional Phonological Therapy

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.

Software Phonological Therapy- SIFALA

Placebo Therapy BEHAVIORAL

No intervention to improve speech.

Placebo Therapy

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (2)

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

Santa Maria, Rio Grande do Sul, 97015-372, Brazil

Location

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97060-500, Brazil

Location

MeSH Terms

Conditions

Speech Sound Disorder; Speech; Communication Disorders

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations: Small number of the sample, since the study requires treatment, so there are few researchers for the treatments. Also some limitations regarding the human subjectivity of results. However the participants adhered to the treatment.

Results Point of Contact

• Title: Márcia Keske-Soares
• Organization: Federal University of Santa Maria

marcia-keske.soares@ufsm.br

55 55 999726370

Study Officials

• Marcia Keske-Soares, PhD

  Universidade Federal de Santa Maria

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professora Doutora

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: October 17, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: December 18, 2019
• Results First Posted: December 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Results were exposed for three years
• Access Criteria: Researchers with access to Clinical Trials and those who wish to contact the responsible researcher.

Locations

BR (2)