Listen in: Developing and Testing a Therapy Application for Patients With Speech Comprehension Deficits After Stroke. (Listen-in)
Primary Purpose
Aphasia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Auditory comprehension therapy.
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia
Eligibility 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.
Sites / Locations
- UCLondon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
trial arm
Normal therapy arm
Arm Description
100 hours of therapy.
12 weeks of normal therapy.
Outcomes
Primary Outcome Measures
Improvement in auditory comprehension on the comprehensive aphasia test.
Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
Secondary Outcome Measures
Improvement in functional communication
Using patient reported outcomes to look at functional communication changes.
Improvement in production of language
Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
Performance on the Sustained attention to response task
Investigation of improvement on sustained attention using the SART.
Environmental sounds test
Investigation of improvement on the non verbal environmental sounds test.
Test of semantics
Investigation of improvement in semantics knowledge.
Improvement in written language comprehension
Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
Improvement on auditory descrimination
Investigation of improvement on a test of auditory discrimination developed by Dr Holly Robson.
Full Information
NCT ID
NCT02540889
First Posted
August 28, 2015
Last Updated
May 1, 2018
Sponsor
University College, London
Collaborators
University College London Hospitals, Cambridge University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02540889
Brief Title
Listen in: Developing and Testing a Therapy Application for Patients With Speech Comprehension Deficits After Stroke.
Acronym
Listen-in
Official Title
Listen-In: the Development and Testing of a Web-based Therapy Application for Patients With Impaired Speech Comprehension Caused by Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 16, 2016 (Actual)
Primary Completion Date
April 12, 2018 (Actual)
Study Completion Date
April 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
University College London Hospitals, Cambridge University Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trial arm
Arm Type
Experimental
Arm Description
100 hours of therapy.
Arm Title
Normal therapy arm
Arm Type
No Intervention
Arm Description
12 weeks of normal therapy.
Intervention Type
Behavioral
Intervention Name(s)
Auditory comprehension therapy.
Intervention Description
100 hours of Auditory comprehension therapy embedded within a computer game.
Primary Outcome Measure Information:
Title
Improvement in auditory comprehension on the comprehensive aphasia test.
Description
Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
Time Frame
Measured over 36 weeks (0,12,24,36) weeks
Secondary Outcome Measure Information:
Title
Improvement in functional communication
Description
Using patient reported outcomes to look at functional communication changes.
Time Frame
Measured over 36 weeks (0,12,24,36) weeks
Title
Improvement in production of language
Description
Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
Time Frame
Measured over 36 weeks (0,12,24,36) weeks
Title
Performance on the Sustained attention to response task
Description
Investigation of improvement on sustained attention using the SART.
Time Frame
Measured over 36 weeks (0,12,24,36) weeks
Title
Environmental sounds test
Description
Investigation of improvement on the non verbal environmental sounds test.
Time Frame
Measured over 36 weeks (0,12,24,36) weeks
Title
Test of semantics
Description
Investigation of improvement in semantics knowledge.
Time Frame
Measured over 36 weeks (0,12,24,36) weeks
Title
Improvement in written language comprehension
Description
Investigation of improvement on a functionally relevant area of a widely used test of aphasia.
Time Frame
Measured over 36 weeks (0,12,24,36) weeks
Title
Improvement on auditory descrimination
Description
Investigation of improvement on a test of auditory discrimination developed by Dr Holly Robson.
Time Frame
Measured over 36 weeks (0,12,24,36) weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Leff, PhD
Organizational Affiliation
ucl
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLondon
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33154182
Citation
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.
Results Reference
derived
Learn more about this trial
Listen in: Developing and Testing a Therapy Application for Patients With Speech Comprehension Deficits After Stroke.
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