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Trial record 94 of 361 for:    "Speech Disorder"

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
Sponsor:
Collaborators:
University College London Hospitals
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment Phase
Aphasia Behavioral: Auditory comprehension therapy. Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
UCLondon
London, United Kingdom
Sponsors and Collaborators
University College, London
University College London Hospitals
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Alex Leff, PhD ucl

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02540889     History of Changes
Other Study ID Numbers: 14/0452
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: July 2017

Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms