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

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

Study Overview

• Status: Completed
• Conditions: Aphasia
• Intervention / Treatment: Behavioral: Auditory comprehension therapy.

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • UCLondon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in auditory comprehension on the comprehensive aphasia test.	Investigation of improvement on a functionally relevant area of a widely used test of aphasia.	Measured over 36 weeks (0,12,24,36) weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in functional communication	Using patient reported outcomes to look at functional communication changes.	Measured over 36 weeks (0,12,24,36) weeks
Improvement in production of language	Investigation of improvement on a functionally relevant area of a widely used test of aphasia.	Measured over 36 weeks (0,12,24,36) weeks
Performance on the Sustained attention to response task	Investigation of improvement on sustained attention using the SART.	Measured over 36 weeks (0,12,24,36) weeks
Environmental sounds test	Investigation of improvement on the non verbal environmental sounds test.	Measured over 36 weeks (0,12,24,36) weeks
Test of semantics	Investigation of improvement in semantics knowledge.	Measured over 36 weeks (0,12,24,36) weeks
Improvement in written language comprehension	Investigation of improvement on a functionally relevant area of a widely used test of aphasia.	Measured over 36 weeks (0,12,24,36) weeks
Improvement on auditory descrimination	Investigation of improvement on a test of auditory discrimination developed by Dr Holly Robson.	Measured over 36 weeks (0,12,24,36) weeks

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: University College London Hospitals; Cambridge University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Alex Leff, PhD, UCL

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2016
• Primary Completion (ACTUAL): April 12, 2018
• Study Completion (ACTUAL): April 12, 2018

Study Registration Dates

• First Submitted: August 28, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (ESTIMATE): September 4, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: 14/0452