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

Aphasia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540889
• Other study ID #: 14/0452
• Status: Completed
• Phase: N/A
• Start date: May 16, 2016
• Est. completion date: April 12, 2018

Study information

• Verified date: July 2017
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 12, 2018
• Est. primary completion date: April 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia

Intervention

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

Locations

Country	Name	City	State
United Kingdom	UCLondon	London

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	Cambridge University Hospitals NHS Foundation Trust, University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in functional communication	Using patient reported outcomes to look at functional communication changes.	Measured over 36 weeks (0,12,24,36) weeks
Secondary	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
Secondary	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
Secondary	Environmental sounds test	Investigation of improvement on the non verbal environmental sounds test.	Measured over 36 weeks (0,12,24,36) weeks
Secondary	Test of semantics	Investigation of improvement in semantics knowledge.	Measured over 36 weeks (0,12,24,36) weeks
Secondary	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
Secondary	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