Listen in: Developing and Testing a Therapy Application for Patients With Speech Comprehension Deficits After Stroke. (Listen-in)
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|ClinicalTrials.gov Identifier: NCT02540889|
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aphasia||Behavioral: Auditory comprehension therapy.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Listen-In: the Development and Testing of a Web-based Therapy Application for Patients With Impaired Speech Comprehension Caused by Stroke|
|Actual Study Start Date :||May 16, 2016|
|Actual Primary Completion Date :||April 12, 2018|
|Actual Study Completion Date :||April 12, 2018|
Experimental: trial arm
100 hours of therapy.
Behavioral: Auditory comprehension therapy.
100 hours of Auditory comprehension therapy embedded within a computer game.
No Intervention: Normal therapy arm
12 weeks of normal therapy.
- Improvement in auditory comprehension on the comprehensive aphasia test. [ Time Frame: Measured over 36 weeks (0,12,24,36) weeks ]Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
- Improvement in functional communication [ Time Frame: Measured over 36 weeks (0,12,24,36) weeks ]Using patient reported outcomes to look at functional communication changes.
- Improvement in production of language [ Time Frame: Measured over 36 weeks (0,12,24,36) weeks ]Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
- Performance on the Sustained attention to response task [ Time Frame: Measured over 36 weeks (0,12,24,36) weeks ]Investigation of improvement on sustained attention using the SART.
- Environmental sounds test [ Time Frame: Measured over 36 weeks (0,12,24,36) weeks ]Investigation of improvement on the non verbal environmental sounds test.
- Test of semantics [ Time Frame: Measured over 36 weeks (0,12,24,36) weeks ]Investigation of improvement in semantics knowledge.
- Improvement in written language comprehension [ Time Frame: Measured over 36 weeks (0,12,24,36) weeks ]Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
- Improvement on auditory descrimination [ Time Frame: Measured over 36 weeks (0,12,24,36) weeks ]Investigation of improvement on a test of auditory discrimination developed by Dr Holly Robson.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540889
|London, United Kingdom|
|Principal Investigator:||Alex Leff, PhD||ucl|