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

University College London (UCL)

Status: Completed

Conditions: Aphasia

Treatments: Behavioral: Auditory comprehension therapy.

Study type: Interventional

Funder types: Other

Identifiers

NCT02540889

14/0452

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 2 patient groups

trial arm

Experimental group

Description:

100 hours of therapy.

Treatment:

Behavioral: Auditory comprehension therapy.

Normal therapy arm

No Intervention group

Description:

12 weeks of normal therapy.