跳至主要内容
临床试验/NCT02935062
NCT02935062已完成不适用

New Therapeutical Perspectives in Cases of Phonological Disorders

Universidade Federal de Santa Maria4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
4
主要终点
Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

P300- Long-latency Auditory Evoked Potential

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcia Keske Soares

Professora Doutora

Universidade Federal de Santa Maria

研究点 (4)

Loading locations...

相似试验

New Therapeutical Perspectives in Cases of... | 临床试验