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临床试验/NCT02540889
NCT02540889已完成不适用

Listen-In: the Development and Testing of a Web-based Therapy Application for Patients With Impaired Speech Comprehension Caused by Stroke

University College, London1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年5月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Improvement in auditory comprehension on the comprehensive aphasia test.

研究概览

简要总结

The main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. Listen-In will provide an effective speech comprehension training tool that patients with aphasia can use to practice independently. This will free up therapists time to provide additional assessment, supervision and functional intervention in a highly cost effective manner.

详细描述

The main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. Listen In will provide an effective speech comprehension training tool that patients can use to practice independently. This will free up SALT time to provide additional assessment, supervision and functional intervention in a highly cost effective manner.

Phase 1 (24 months. London, Newcastle, Cambridge): Development of Listen In, including diagnostic and therapeutic components, driven by patient user's feedback (alpha and beta testing). The intervention is detailed below and is based on current SALT practice. It will be adaptive, provide feedback and target auditory perception at many levels: the phonemic, lexical and sentence level processing of heard verbal stimuli, as well as auditory short term memory and nonverbal sound discrimination.

Phase 2 (12 months. London and Cambridge): A pilot, randomised, crossover, clinical trial of Listen-In in a group of aphasic patients in the chronic post-stroke period. A power calculation suggests that we will need 36 patents, 18 in each arm. The comparison will be standard SALT clinical care. The main outcome measure is a clinically relevant improvement on the comprehension of spoken language score of the Comprehensive Aphasia Test (Swinburn, 2004). Secondary outcomes include improvements in social activity and participation. The milestones for this phase will be: 50% recruitment into study and last patient, last visit.

Phase 3 (funded outside i4i grant) will be the rollout of the therapy application on the internet with a pragmatic trial of whether therapy gains can be made outside the confines of a clinical trial. The comparison will be on similar outcome measures as Phase 2 with a control test on sustained attention (internal control) that we predict will not improve with therapy.

研究设计

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

入排标准

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

入选标准

  • •any type of stroke but greater than 6 months post onset
  • •evidence of receptive aphasia
  • •English as their main language
  • •able to give informed consent
  • •age 18 years or above
  • •no diagnosis of degenerative brain disease.

排除标准

  • •Stroke less than 6 months post onset
  • •No evidence of receptive aphasia
  • •English not their main language
  • •Unable to give informed consent
  • •Less than 18 years old
  • •diagnosis of degenerative brain disease.

研究组 & 干预措施

trial arm

Experimental

100 hours of therapy.

干预措施: Auditory comprehension therapy. (Behavioral)

Normal therapy arm

No Intervention

12 weeks of normal therapy.

结局指标

主要结局

Improvement in auditory comprehension on the comprehensive aphasia test.

时间窗: Measured over 36 weeks (0,12,24,36) weeks

Investigation of improvement on a functionally relevant area of a widely used test of aphasia.

次要结局

  • Improvement in production of language(Measured over 36 weeks (0,12,24,36) weeks)
  • Test of semantics(Measured over 36 weeks (0,12,24,36) weeks)
  • Improvement on auditory descrimination(Measured over 36 weeks (0,12,24,36) weeks)
  • Improvement in written language comprehension(Measured over 36 weeks (0,12,24,36) weeks)
  • Improvement in functional communication(Measured over 36 weeks (0,12,24,36) weeks)
  • Performance on the Sustained attention to response task(Measured over 36 weeks (0,12,24,36) weeks)
  • Environmental sounds test(Measured over 36 weeks (0,12,24,36) weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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