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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-16

Study Completion Date

2018-04-12

Brief Summary

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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

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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.

Conditions

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Aphasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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trial arm

100 hours of therapy.

Group Type EXPERIMENTAL

Auditory comprehension therapy.

Intervention Type BEHAVIORAL

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

Normal therapy arm

12 weeks of normal therapy.

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College London Hospitals

OTHER

Sponsor Role collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Leff, PhD

Role: PRINCIPAL_INVESTIGATOR

ucl

Locations

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UCLondon

London, , United Kingdom

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 33154182 (View on PubMed)

Other Identifiers

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14/0452

Identifier Type: -

Identifier Source: org_study_id

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