Listen in: Developing and Testing a Therapy Application for Patients With Speech Comprehension Deficits After Stroke.
NCT ID: NCT02540889
Last Updated: 2018-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2016-05-16
2018-04-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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trial arm
100 hours of therapy.
Auditory comprehension therapy.
100 hours of Auditory comprehension therapy embedded within a computer game.
Normal therapy arm
12 weeks of normal therapy.
No interventions assigned to this group
Interventions
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Auditory comprehension therapy.
100 hours of Auditory comprehension therapy embedded within a computer game.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University College London Hospitals
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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Alex Leff, PhD
Role: PRINCIPAL_INVESTIGATOR
ucl
Locations
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UCLondon
London, , United Kingdom
Countries
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References
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Fleming V, Brownsett S, Krason A, Maegli MA, Coley-Fisher H, Ong YH, Nardo D, Leach R, Howard D, Robson H, Warburton E, Ashburner J, Price CJ, Crinion JT, Leff AP. Efficacy of spoken word comprehension therapy in patients with chronic aphasia: a cross-over randomised controlled trial with structural imaging. J Neurol Neurosurg Psychiatry. 2020 Nov 5;92(4):418-24. doi: 10.1136/jnnp-2020-324256. Online ahead of print.
Other Identifiers
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14/0452
Identifier Type: -
Identifier Source: org_study_id
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