Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04108364 |
| Other study ID # |
MYB155164 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
January 5, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Rising life expectancy is leading to a rising incidence of strokes worldwide. Approximately
one third of people who had a stroke live with a communication disorder, aphasia, which is
associated with the largest negative relationship to quality of life. In chronic stages,
people with aphasia (PwA) often do not receive any rehabilitation, despite treatment being
shown to significantly reduce impairment. In contrast to existing computerized aphasia
treatment, VoiceAdapt is an innovative and motivating application for PwA that provides
adaptive and context-aware training lessons via speech interaction on the mobile device. A
user-centred design process and motivational gamification ensure long-term engagement in
training. Through providing an autonomously usable and low-cost tool, VoiceAdapt will
positively affect PwA's self-esteem and social inclusion, leading to higher quality of life.
Description:
Purpose:
The purpose of the study proposed in this ethics application is to examine the impact of an
adaptive speech-language treatment app, created using principles of user-centred design, on
language and communication outcomes of people with aphasia (PwA) within a randomized
controlled trial.
Background:
Nearly one third of individuals who have a stroke will present with aphasia, a communication
impairment that affects the ability to speak, understand, read and write. People with aphasia
(PwA) have been shown to demonstrate more limitations in their participation in daily
activities, lower quality of life and a higher incidence of depression relative to
post-stroke individuals without aphasia, even when other factors such as physical ability,
social support and well-being were similar.
The overall goals of the VoiceAdapt research project are to: 1) conduct a needs survey with
PwA and speech-language pathologists (SLPs); 2) develop an app employing a user-centred
design process; and 3) conduct a randomized controlled trial. Using user-centred design, end
users and stakeholders (PwA, therapists and formal/informal caregivers) will be engage din a
needs survey during the technology development process. Outcomes will be analyzed to
elaborate implications for decision makers as to how to implement such adaptive training
environments in stroke rehabilitation. This aspect of the research (i.e., Goals 1 & 2) will
be carried out by consortium members in Austria and Germany. Only the randomized controlled
trial (Goal 3), which is the subject of the present application, will be conducted at the
University of Alberta and the University of Toronto.
PwA will be provided with a personalized speech-language treatment app (i.e., on a tablet),
which automatically adapts the exercises to the users' actual skill level. Individual
learning progress of PwA will be supported by personalized and gamified training elements to
achieve higher compliance and adherence to the exercises. As a primary outcome, the adaptive
assistive technology will examine language performance related to the specific intervention
of the personalized speech-language treatment app. Additional objectives will examine the
change in the overall language and communication functioning of PwA; the well-being and
quality of life of PwA and their caregiver's perception of communication effectiveness after
intervention with the treatment app.
The research will be carried out by the VoiceAdapt Consortium, which brings together the
resources of five participating international institutions. Research partners have expertise
in the fields of technology/e-health and graphical design skills (Nurogames, NG),
personalization and adaptvitiy (Technical University of Berlin, TUB), user-centred design and
gamification/persuasion (Austrian Institute of Technology, AIT), and clinical research and
intervention studies (University of Toronto, UoT; University of Alberta, UoA).
Research Methods/Procedures:
Researchers at the University of Alberta and University of Toronto will be the primary
investigators of the randomized controlled trial (RCT) portion of the VoiceAdapt Project. The
RCT will involve 80 PwA in total across University of Alberta and University of Toronto
sites.
Design of the RCT: The RCT will be a two arm, randomized, waitlist-controlled, crossover
group design. In Phase 1, PWA randomized to the intervention group will train with
VoiceAdapt. The control group will be a waitlist treatment-deferred group. In Phase 2, the
control group will train with VoiceAdapt. The randomization of participants will be achieved
by computer-generated assignment.
Participants: All participants will have suffered a left hemisphere stroke, be at least 6
months post-onset, and will have aphasia as defined by performance on the Western Aphasia
Battery - Rev. (Aphasia Quotient greater than or equal to 30, with a prominent verbal
expression impairment), but type of aphasia will not be an inclusion criterion. Participants
will speak English as their primary language, pass screenings of visual perception, hearing
and basic cognitive functioning and be willing to commit to participation for the study
duration.
Intervention: Each intervention phase will last for 5 weeks. During this period, participants
in the experimental condition will be asked to do speech language tasks 5 days a week for 60
minutes via the VoiceAdapt app (intervention group). The control group will not be engaged in
any one on one speech therapy during the first intervention phase (Phase 1). During the
second intervention phase (Phase 2), the control group will participate in training with the
VoiceAdapt app (60 minutes/day x 5 days/week) and the intervention group from Phase 1 will
crossover into receiving no treatment. Research staff will check in with individuals in the
intervention group on a weekly basis to monitor and adjust treatment exercises. Research
staff will check in with participants in the control group twice during their respective
control phase.
Outcome Measures: In line with the recommended core outcome measures for aphasia research
(Wallace et al., 2019), participants in both groups will be tested before and after each
condition on the following measures: the primary outcome measure will be the Boston Naming
Test (BNT) to measure naming; secondary outcome measures will be: Western Aphasia
Battery-Revised (WAB-R); Stroke and Aphasia Quality of Life Scale (SAQOL-39) to measure
quality of life; and Communication Effectiveness Index (CETI) to measure the person with
aphasia and the partners' perception of the participant's communication. In addition to these
measures, the Situational Motivation Scale (SIMS) and an end of study questionnaire will be
provided to all participants.
Plan for Data Analysis:
The primary analysis will be a one-sided hypothesis test of the null hypothesis of the change
in naming on the Boston Naming Test (BNT) from baseline to week 6, tested at the 0.1 level of
significance. The observed change on the BNT as well as the baseline, 6 week and follow up
values will be summarized for each group as means and standard deviations. Secondary outcomes
will be summarized using means (SD), medians (IQR) or proportions (CI), and analyzed using t
tests, as appropriate. All analyses will be presented in aggregate.
