NCT02540889

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

May 16, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2018

Completed
Last Updated

May 2, 2018

Status Verified

July 1, 2017

Enrollment Period

1.9 years

First QC Date

August 28, 2015

Last Update Submit

May 1, 2018

Conditions

Aphasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Improvement in functional communication

    Measured over 36 weeks (0,12,24,36) weeks

  • Improvement in production of language

    Measured over 36 weeks (0,12,24,36) weeks

  • Performance on the Sustained attention to response task

    Measured over 36 weeks (0,12,24,36) weeks

  • Environmental sounds test

    Measured over 36 weeks (0,12,24,36) weeks

  • Test of semantics

    Measured over 36 weeks (0,12,24,36) weeks

  • +2 more secondary outcomes

Study Arms (2)

trial arm

EXPERIMENTAL

100 hours of therapy.

Behavioral: Auditory comprehension therapy.

Normal therapy arm

NO INTERVENTION

12 weeks of normal therapy.

Interventions

Auditory comprehension therapy.BEHAVIORAL

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

trial arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLondon

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33154182DERIVED

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alex Leff, PhD

    ucl

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 4, 2015

Study Start

May 16, 2016

Primary Completion

April 12, 2018

Study Completion

April 12, 2018

Last Updated

May 2, 2018

Record last verified: 2017-07

Locations

GB(1)