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

Sponsor
University College, London (Other)
Overall Status
Completed
CT.gov ID
NCT02540889
Collaborator
University College London Hospitals (Other), Cambridge University Hospitals NHS Foundation Trust (Other)
36
1
2
22.9
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Auditory comprehension therapy.
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Listen-In: the Development and Testing of a Web-based Therapy Application for Patients With Impaired Speech Comprehension Caused by Stroke
Actual Study Start Date :
May 16, 2016
Actual Primary Completion Date :
Apr 12, 2018
Actual Study Completion Date :
Apr 12, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Improvement in auditory comprehension on the comprehensive aphasia test. [Measured over 36 weeks (0,12,24,36) weeks]

    Investigation of improvement on a functionally relevant area of a widely used test of aphasia.

Secondary Outcome Measures

  1. Improvement in functional communication [Measured over 36 weeks (0,12,24,36) weeks]

    Using patient reported outcomes to look at functional communication changes.

  2. Improvement in production of language [Measured over 36 weeks (0,12,24,36) weeks]

    Investigation of improvement on a functionally relevant area of a widely used test of aphasia.

  3. Performance on the Sustained attention to response task [Measured over 36 weeks (0,12,24,36) weeks]

    Investigation of improvement on sustained attention using the SART.

  4. Environmental sounds test [Measured over 36 weeks (0,12,24,36) weeks]

    Investigation of improvement on the non verbal environmental sounds test.

  5. Test of semantics [Measured over 36 weeks (0,12,24,36) weeks]

    Investigation of improvement in semantics knowledge.

  6. Improvement in written language comprehension [Measured over 36 weeks (0,12,24,36) weeks]

    Investigation of improvement on a functionally relevant area of a widely used test of aphasia.

  7. Improvement on auditory descrimination [Measured over 36 weeks (0,12,24,36) weeks]

    Investigation of improvement on a test of auditory discrimination developed by Dr Holly Robson.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLondon London United Kingdom

Sponsors and Collaborators

  • University College, London
  • University College London Hospitals
  • Cambridge University Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Alex Leff, PhD, ucl

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College, London
ClinicalTrials.gov Identifier:
NCT02540889
Other Study ID Numbers:
  • 14/0452
First Posted:
Sep 4, 2015
Last Update Posted:
May 2, 2018
Last Verified:
Jul 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2018