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Completed

NCT Number: NCT02540889

Listen in: Developing and Testing a Therapy Application for Patients With Speech Comprehension Deficits After Stroke.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLondon

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auditory comprehension therapy.

Behavioral

100 hours of Auditory comprehension therapy embedded within a computer game.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. Environmental sounds test

    Time frame: Measured over 36 weeks (0,12,24,36) weeks

    Investigation of improvement on the non verbal environmental sounds test.

  5. Test of semantics

    Time frame: Measured over 36 weeks (0,12,24,36) weeks

    Investigation of improvement in semantics knowledge.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • University College London Hospitals

Registry information

Official study title

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

Acronym: Listen-in

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 4, 2015
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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