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Digital Interventions in Neurorehabilitation: iTALKbetter

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ClinicalTrials.gov Identifier: NCT04566081
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:

iTALKBetter will provide an app-based therapy for people with word retrieval difficulties who have had a stroke.

This study aims to test the therapy application for people with naming difficulties through a small scale randomized controlled trial.


Condition or disease Intervention/treatment Phase
Stroke Aphasia Anomia Other: iTALKbetter: deterministic Other: iTALKbetter: reactive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Digital Interventions in Neuro-Rehabilitation (DINR): A Digital Neuro Intervention (DNI) for Word Retrieval (Anomia)
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Active Comparator: iTALKbetter: deterministic

Participants will receive the deterministic version of the iTALKbetter therapy for 6 weeks. Participants are required to use the therapy for 1.5 hours everyday to reach the required dose of 60 hours over the 6 week period.

iTALKbetter:deterministic version will randomise the order all of the words that are to be trained and participants will cycle through all of these words regardless of their performance until complete at which point the order is re-randomised and participants begin the cycle again.

Other: iTALKbetter: deterministic
A word retrieval therapy application
Other Name: deterministic iTB

Active Comparator: iTALKbetter: reactive

Participants will receive the reactive version of the iTALKbetter therapy for 6 weeks. Participants are required to use the therapy for 1.5 hours everyday to reach the required dose of 60 hours over the 6 week period.

iTALKbetter reactive version is identical to the deterministic version for the first cycle only. From then on the words participants are trained on can change depending on their performance on that word over a number of cycles. Words that participants are failing to retrieve over a number of cycles will be retired from the therapy as they are deemed too difficult for a given participant. Similarly words that are correctly retrieved over a number of consecutive cycles are also retired from the therapy as they are deemed to have been learned. In this way iTALKbetter reactive version will gradually give each participant a personalised corpus of words that they can train on, focusing on the words where they stand to make the most improvements.

Other: iTALKbetter: reactive
A word retrieval therapy application




Primary Outcome Measures :
  1. Change in accuracy performance on a bespoke Word Retrieval Test: WRT [ Time Frame: baseline (week 1), pre intervention (week 12), post-intervention (week 18) ]
    The WRT is custom test of word retrieval comprised of a subset of the trained and untrained items form the iTALKbetter therapy. Participants accuracy on the word retrieval test is measured at multiple timepoints (baseline, pre intervention, during intervention and post intervention).


Secondary Outcome Measures :
  1. Patient and carer reported outcome measures [ Time Frame: pre intervention (week 12), post intervention (week 18) ]
    Qualitative semi-structured interviews to assess a variety of outcomes.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any type of stroke but at least 6 months after onset.
  • Evidence of aphasia on the Comprehensive Aphasia Test
  • English as their dominant language
  • Able to tolerate MRI brain scan
  • Able to give informed consent
  • Able to use the DNI (app)

Exclusion Criteria:

  • No diagnosis of developmental language disorders
  • No diagnosis of severe dementia or primary progressive aphasia
  • No major co-existing neurological or psychiatric diagnosis
  • No contraindications to brain scanner (e.g. the presence of ferromagnetic implants or other metallic or electronic objects in the body, weight over 24 stone, claustrophobia or pregnancy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566081


Contacts
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Contact: Alexander P Leff, Professor 02076791177 a.leff@ucl.ac.uk
Contact: Victoria Fleming, PhD 02076791134 victoria.fleming@ucl.ac.uk

Locations
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United Kingdom
University College London Recruiting
London, United Kingdom, WC1E6BT
Contact: Alexander P Leff, Professor         
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Alexander P Leff, Professor University College, London
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04566081    
Other Study ID Numbers: 18\0071
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Anomia
Word Retrieval
Digital Therapy
Additional relevant MeSH terms:
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Aphasia
Anomia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases