Trial Outcomes & Findings for Digital Interventions in Neurorehabilitation: iTALKbetter (NCT NCT04566081)
NCT ID: NCT04566081
Last Updated: 2026-03-10
Results Overview
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 two timepoints: pre intervention (T3), and post intervention (T4). There are 110 trained and 110 untrained items. Accuracy is reported as a percentage score (min = 0%, max = 100%) for each of the four conditions. The outcome is the percentage change in performance on the WRT. To investigate the efficacy of iTalkBetter in improving the retrieval of trained single words on the WRT, a repeated measures ANOVA was used which compared change in accuracy over the pre-therapy block and the therapy block. There were two factors, each with two levels: time (pre-therapy (Baseline to T3) and therapy (T3 to T4)); and item (trained and untrained lexical items).
COMPLETED
NA
31 participants
Two time points: 1. Pre- intervention (T3 = 6 weeks post baseline) 2. Post-intervention (T4 = 12 weeks post baseline)
2026-03-10
Participant Flow
31 PWA were recruited for the study. Recruitment was from the Predicting Language Outcome and Recovery After Stroke (PLORAS) database and from a local outpatient clinic. Between Sep 7, 2020 and Mar 1, 2022.
Participant milestones
| Measure |
iTalkBetter Therapy Group
The iTalkBetter clinical study was a small-scale, repeated measures, control trial in which participants completed 6 weeks of therapy with the iTalkBetter app, aiming to complete 60 hours of therapy
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|---|---|
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Overall Study
STARTED
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31
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Overall Study
COMPLETED
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27
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
iTalkBetter Therapy Group
The iTalkBetter clinical study was a small-scale, repeated measures, control trial in which participants completed 6 weeks of therapy with the iTalkBetter app, aiming to complete 60 hours of therapy
|
|---|---|
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Overall Study
Death
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1
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Overall Study
Withdrawal by Subject
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3
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
iTALKbetter
n=27 Participants
The iTalkBetter clinical study was a small-scale, repeated measures, control trial in which participants completed 6 weeks of therapy with the iTalkBetter app, aiming to complete 60 hours of therapy
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|---|---|
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Age, Continuous
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62 Years
STANDARD_DEVIATION 12 • n=27 Participants
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Sex: Female, Male
Female
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7 Participants
n=27 Participants
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Sex: Female, Male
Male
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20 Participants
n=27 Participants
|
|
Word Retrieval Test (WRT)
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32 Percentage
STANDARD_DEVIATION 15.77 • n=27 Participants
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PRIMARY outcome
Timeframe: Two time points: 1. Pre- intervention (T3 = 6 weeks post baseline) 2. Post-intervention (T4 = 12 weeks post baseline)Population: Results are for the 27 participants who completed the study.
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 two timepoints: pre intervention (T3), and post intervention (T4). There are 110 trained and 110 untrained items. Accuracy is reported as a percentage score (min = 0%, max = 100%) for each of the four conditions. The outcome is the percentage change in performance on the WRT. To investigate the efficacy of iTalkBetter in improving the retrieval of trained single words on the WRT, a repeated measures ANOVA was used which compared change in accuracy over the pre-therapy block and the therapy block. There were two factors, each with two levels: time (pre-therapy (Baseline to T3) and therapy (T3 to T4)); and item (trained and untrained lexical items).
Outcome measures
| Measure |
iTALKbetter
n=27 Participants
The therapy is a single-word picture-naming task with error-reducing, phonological cues, and includes 220 lexical items from all major word classes. The therapy content also includes both concrete (highly imageable words which portray tangible concepts e.g., 'cat') and abstract words (low imageability words which refer to intangible concepts e.g., 'confidence').
A novel automatic speech recogniser was developed by a member of the team and incorporated into the therapy. This naming utterance verification system (NUVA) utilised a deep learning element that classified, in real time, a naming attempt as correct or incorrect. This allowed the app to determine the next cue level and also enabled the provision of immediate feedback to the PWA for each individual practice of a word (trial). See Supplementary materials for the item progression algorithm. iTalkBetter also utilises gamification to reduce the boredom and fatigue effects often associated with repetitive and intensive tasks, thereby decreasing participant drop-out rates. In iTalkBetter, bright and engaging colours are used in the therapy via the use of an 'outer space' theme, which was designed and developed by our software team, SoftV. Visual feedback, in the form of words ('Well done!') and actions (pictures are collected and stored in sight on screen), are also provided to motivate users when items are correctly named.
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|---|---|
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Accuracy Performance (%) on a Bespoke Word Retrieval Test: WRT. Two Conditions: 1. Trained Items 2. Untrained Items
Untrained items (T4)
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43 percentage
Standard Error 1.95
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Accuracy Performance (%) on a Bespoke Word Retrieval Test: WRT. Two Conditions: 1. Trained Items 2. Untrained Items
Trained items (T3)
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38.3 percentage
Standard Error 0.85
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Accuracy Performance (%) on a Bespoke Word Retrieval Test: WRT. Two Conditions: 1. Trained Items 2. Untrained Items
Untrained items (T3)
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38.4 percentage
Standard Error 0.95
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Accuracy Performance (%) on a Bespoke Word Retrieval Test: WRT. Two Conditions: 1. Trained Items 2. Untrained Items
Trained items (T4)
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50.6 percentage
Standard Error 1.8
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SECONDARY outcome
Timeframe: Baseline and Post-intervention (T4 = 12 weeks post Baseline)Semi-structured interviews were carried out with partcipants to better understand why they took part in the study, and what they hoped to gain (baseline) and then reflections on what it was like taking part in the study (Last time point)
Outcome measures
Outcome data not reported
Adverse Events
iTALKbetter
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Alex Leff
UCL Queen Square Institute of Neurology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place