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Clinical Trials/NCT02540889
NCT02540889
Completed
N/A

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

University College, London1 site in 1 country36 target enrollmentMay 16, 2016
ConditionsAphasia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aphasia
Sponsor
University College, London
Enrollment
36
Locations
1
Primary Endpoint
Improvement in auditory comprehension on the comprehensive aphasia test.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 16, 2016
End Date
April 12, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)

Study Sites (1)

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