Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04566081 |
| Other study ID # |
18\0071 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 14, 2019 |
| Est. completion date |
February 25, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University College, London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Mortality from stroke in the UK has reduced from 21% in 1999 to 12% in 2008. However, stroke
prevalence has been increasing, the consequence of socioeconomic and scientific advances that
have improved survival; which means that more people are surviving with long-standing
disability. Language impairment (aphasia) is the second most common major impairment after
stroke, with a prevalence of 250,000 in the UK. Aphasia may respond to therapy many months
and years after the stroke occurs, but provision of specialist therapy (speech and language
therapy - SALT) is far below that needed to provide optimal rehabilitation.
The investigators will address this by targeting a common symptom of post-stroke aphasia:
impaired word retrieval problems. This is particularly important in patients receiving
rehabilitation for associated disabilities as poor speech production can impair
participation/compliance with treatment programmes. The study is designed to improve word
retrieval in patients with post-stroke aphasia, who are in the chronic phase (>6 months
post-stroke).
The main aim is to test the clinical efficacy of a novel, web-based, DNI. iTALKbetter will
provide an effective 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.
iTALKbetter will provide an app-based therapy for people with word retrieval difficulties who
have had a stroke (naming app for a wide variety of common words and phrases).
This Digital Neuro Intervention (DNI) will provide the opportunity for the necessary
increased rehabilitation to help people recover lost naming function. This will alleviate NHS
Speech and Language Therapist (SALT) time and put users in control of when and where they
carry out practice-based language therapy.
Purpose iTALKbetter will provide an app-based therapy for people with word retrieval
difficulties who have had a stroke (naming app for a wide variety of common words and
phrases).
What does it do? The DNI works via mass practice and feedback to the users on a
trial-by-trial basis. The DNI is very simple in a way; it just presents a long series of
pictures for users to name. The DNI will use speech recognition (SR) software in order to
make a binary decision as to whether the user said the correct word or not. This affects what
the next trial (object to name) is and what auditory cue (if any) is provided the next time
the user has to name the same item.
What is the clinical trial design? A small, well-defined sample of patients with the
potential to benefit from the DNI will be recruited. The main outcome measure is whether the
DNI is effective at improving naming impairments. This comparison is within-subject and is
achieved by comparing post-therapy measures to multiple baseline measures. A comparison of
two different versions of the therapy (a between group comparison) is also planned to answer
the secondary question of whether the therapy can be optimised. Outcome measures will be
collected by the research team using a variety of standardized and non-standardized tests of
language and cognition. These outcome measures are not built into the DNI at this point.
The DNI will be introduced to the participant when attending a testing session. One of the
research team will explain how to use the DNI, provide instructions for the user, and give
some time for practice items. When confident that the participant can use the DNI
independently, the participant will take the device home and continue their therapy
(suggested therapy time is 5-10 hours per week) which will be simultaneously monitored by the
research team. The research team will also check in on the participant weekly to trouble
shoot any difficulties they may have (whether motivational or technical). When the
participant has completed the therapy block, they will be invited in again for testing and
they will return the mobile device with the DNI on it. The participants who continue to
receive standard care during the therapy block will be asked to record and submit details to
the research team
Why is the research considered worth doing? Standard (face to face) Speech and Language
Therapy (SALT) has a huge evidence-base but patients in the NHS have unmet therapy needs due
to a lack of resources. The evidence from speech-therapy highlights the amount of
time-on-task required to improve patients' ability to communicate. Naming problems are common
and impact on the patients' wellbeing and social inclusion. There is also good evidence that
current existing therapeutic approaches work.
A Cochrane review of 39 RCT's involving 2518 participants concluded that speech-therapy
results in significant benefits to patients' functional communication. Many of these studies
involve high doses of therapy. A meta-analysis examining dose found that positive therapy
studies averaged 98 hours of speech therapy in total, while negative studies averaged 43. In
the NHS a patient with aphasia can expect a total average of 6-10 hours of SALT. When the
intervention takes place or how intensely seems less relevant to recovery. The solution to
the lack of available SALT therapy is to produce digital neuro-interventions that give
patients the opportunity to practice scientifically validated, impairment based therapy when
and where it suits them which gives them access to optimum therapy dose.
Recent improvements in acute stroke care means that demand for already limited NHS resources
will increase. Commissioners will need to address this growing unmet need and innovative
relatively cheap interventions like this one will provide necessary rehabilitation.
Therapy can be effortful for patients who can sometimes be too fatigued when the therapist
comes to do their session. This digital neuro-intervention will provide optimum availability
of therapy and therefore place the patient in control of how much they do. The investigators
aim to combat this by creating an engaging and adaptive therapy. The adaptiveness will serve
to reward the patients for their efforts without ever making them feel like they are failing.
This will hopefully boost how long they spend in therapy and therefore make greater gains.
There are therapy 'apps" available for patients with aphasia but the scientific basis for
them is lacking and none are targeted for speech production. By using voice recognition
software the intervention will be uniquely designed to be used by patients with word
retrieval impairments.
What new information will the research provide? The concept of the therapy component is based
on standard SALT practice and thus has a strong proof of concept basis, as do the proposed
outcome measures. The novel component is packaging it in a user- friendly web-app that is
designed for and by people with word-retrieval problems. This is ambitious and yet realistic
goal to provide a world-wide evidence-based therapy that can benefit many. This digital
neuro-intervention will be in contrast to the plethora of apps available online claiming
cognitive training without having scientific proof.
The iTALKbetter research study is a small-scale, randomised, clinical trial for participants
with word retrieval impairments post-stroke. The main research question is whether
iTALKbetter improves patients' naming ability for trained items. This hypothesis is tested by
assessing participants naming abilities on two matched lists of items, half are trained items
and half are untrained. A secondary question is whether it matters how the software
progresses patients through the therapy. This hypothesis is tested by creating two different
versions of iTALKbetter: 'deterministic' and 'reactive'. Participants will be randomised
(using minimisation) to one of two of these versions of the therapy. Participants practice
with the therapy for set periods of time (therapy block) following a series of (three)
baseline measures split over a single, pre-therapy block (see Trial design section 5). The
main outcome measure will be a clinically relevant improvement on the naming ability of the
trained items (compared to untrained control items). Secondary outcomes include investigating
which therapy version optimises recovery on naming accuracy and also improvements in social
activity and participation and participant and/or carer reported outcome measures (PROMS).
The investigators also plan to capture brain-based data (structural MRI) in order to test a
series of secondary hypotheses relating to both how and why the therapy may work in some
participants but not others. All brain imaging will be outside of standard care for the
participants and take place at UCL by trained staff.
Hypotheses and Objectives H1-Primary: Does iTB improve naming performance on trained items?
This is a within-subject comparison. The criteria for success is a 10% (raw, or
unstandardized) relative improvement in performance. This effect size was used in the recent
Big Cactus study.
H2-Secondary: Does reactive iTB significantly improve performance compared with deterministic
iTB?
This is two factor analysis with both a within-subject factor (trained vs. untrained items)
and a between-group factor (reactive iTB vs. deterministic iTB). The criteria for success is
a 5% (raw, or unstandardized) relative difference in performance. This is half the effect
size used in the recent Big Cactus study, but that was to compare therapy with no therapy,
here expected gains may be more marginal as both groups are receiving the therapy items, just
in different orders.
Primary Objective: Does iTB improve naming performance on trained items?
Secondary Objective(s):
The investigators believe that using this DNI will improve word retrieval on trained items by
providing a known therapy used by SLT's through a digital app and by enabling an increased
dose of therapy. However, another objective is that by using this DNI and practicing every
day, there will be changes in participants' brain structure and in the health of the
participants and their carers.
- Does reactive iTB significantly improve performance compared with deterministic iTB?
- Are the therapy effects item-specific or do is there generalization to untrained items?
- Are the effects of the DNI therapy limited to the language domain alone or do they
improve in other cognitive domains (e.g. sustained attention)?
- Does the DNI improve participant's social activity and participation?
- Is the DNI acceptable to participants (can they use it easily)?
- Is the DNI acceptable to participants' carers?
- Does the DNI improve carer health/well-being?
- Does the DNI have any economic benefits?
- Can baseline structural brain imaging explain participants' responses to the DNI?
- Can baseline structural brain imaging be used to predict incoming participants' response
to the DNI?
- Can repeated-measures structural brain imaging identify participants' brain areas that
change in response to the DNI?
