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临床试验/NCT03157492
NCT03157492已完成不适用

Enhanced Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

Gallaudet University9 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
9
主要终点
Change in Sentence Recognition CasperSent (Boothroyd, 2008)

研究概览

简要总结

This study evaluates the benefits of short-term training via telehealth for post-lingually deafened adult cochlear implant users. Half the participants will receive aural rehabilitation and the other half cognitive training. The hypothesis is that short-term aural rehabilitation via telerehab technology will improve outcomes for post-lingually deafened cochlear implant users

详细描述

Aural rehabilitation training (AR) has been demonstrated to improve outcomes for adult cochlear implant users. There are both financial and non-financial barriers to AR service delivery including accessibility (mobility, distance and transportation problems), accommodation (time off work impossible, caring for family) and availability (limited providers in rural areas, financial constraints, and lack of transportation. In this study the investigators will measure the impact of telerehab delivery on optimizing speech recognition, communication function, goals, social participation and hearing handicap.

Twenty-four participants will be randomly assigned to one of two treatment groups: aural rehabilitation (AR) and cognitive training (CT). Participants will complete six 90-minute treatment sessions in their home or office via a telerehab platform. Participants will come to a center for three 90-minute assessment sessions: pre-treatment, 1 week, and 2 months post-treatment.

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 (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Speech Tracking rate of at least 20 words per minute
  • Sentence recognition scores (CasperSent) between 10% and 85%
  • Passing score on cognitive screener (Callahan et al., 2002)

排除标准

  • Less than 18 years of age
  • Pre-lingually deafened
  • Prior Aural Rehabilitation with cochlear implant
  • Greater than three years post-activation of CI

结局指标

主要结局

Change in Sentence Recognition CasperSent (Boothroyd, 2008)

时间窗: Pre-training, One-week and Two-months post-training

Percent correct scores on CasperSent topic-related recorded sentences.

次要结局

  • Change in Client Oriented Scale of Improvement (COSI) (Dillon, James & Ginis, 1997)(Pre-training, One-week and Two-months post-training)
  • Change in Hearing Handicap Inventory (HHI) (Ventry & Weinstein,1982)(Pre-training, One-week and Two-months post-training)
  • Change in Glasgow Benefit Inventory (GBI) (Robinson et al.,1996(One-week and Two-months post-training)
  • Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) (Hinderdink et al., 2000)(Pre-training, One-week and Two-months post-training)

研究者

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

Diane Brewer

Co-Principal Investigator Research Audiologist

Gallaudet University

研究点 (9)

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