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REmote Speech entrainment Therapy with people with long-term acquired and developmental communication disORdErs (RESTORE)

Feasibility of delivering REmote Speech entrainment Therapy with people with long-term acquired and developmental communication disORdErs (RESTORE)

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001160729
Acronym
RESTORE
Enrollment
1
Registered
2022-08-24
Start date
2023-02-23
Completion date
2023-02-23
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Kinephonics app is a new technology to support people with communication difficulties using speech entrainment intervention technique. It is hypothesised the app, with the support from a support worker or allied health assistant, can help adults with a range of backgrounds (including stroke, developmental disorder, autism, brain injury) with improving their speech and language skills. The current study is a pilot study, which will inform the development of a future large clinical trial. The primary objectives of the study are to a) determine the acceptability and feasibility of conducting the study for a large clinical trial in the future using the Kinephonics app with support workers and allied health assistants implementing the intervention; and b) to determine the effect of the Kinephonics app on various speech and language outcomes. Following an assessment visit to capture communication outcomes, participants will be randomised to immediate intervention group or waitlist control group. Each group will receive Kinephonics® speech entrainment sessions 20-30 minutes 1-2 weekly for a total of 12 sessions within 6 weeks. Outcomes will be assessed after each intervention/usual care phase, and 1 month after all phases. fMRI neuroimaging on 20 participants with a background of a stroke before and after the intervention to identify neurological changes with Kinephonics® use is an optional component of the study. Outcomes which will be measured include: * Number of intervention sessions participants attend * Support worker and allied health assistants following the Kinephonics training and intervention requirements * Receptive and expressive language skills before and after the intervention * Speech skills before and after the intervention * Fatigue ratings after participating in the intervention * Optional functional MRI for stroke participants to measure neurological changes * Optional interview to discuss participant and family experience with being in the study

Interventions

The Kinephonics speech entrainment software is a communication app used on portable devices such as phones, laptops, and tablets. It incorporates multiple outputs of visualisation (camera filming the speaker; written text) and audio (text-to-speech generation) produced simultaneously on the screen. Written text and audio outputs of scripts entered into the software allow the speaker to listen to and read the script, as well as observe their face and mouth while speaking. Support workers (SW) and

The Kinephonics speech entrainment software is a communication app used on portable devices such as phones, laptops, and tablets. It incorporates multiple outputs of visualisation (camera filming the speaker; written text) and audio (text-to-speech generation) produced simultaneously on the screen. Written text and audio outputs of scripts entered into the software allow the speaker to listen to and read the script, as well as observe their face and mouth while speaking. Support workers (SW) and allied health assistants (AHA) will be trained by Kinephonics staff to implement the app with adult participants with various etiologies who experience chronic communication disorders. Individual training for each participant's SW/AHA will be completed following the participant's enrollment into the project and prior to their first intervention session (week -1 to week 0). Each participant will attend 12 in-person intervention sessions over 6 weeks with a SW/AHA for approximately 30 minutes each. The intervention is completed within the community during everyday activities. Family members/carers may also be present during the intervention sessions. support workers/allied health assistants will meet with participants in either their home or a community setting, rather than in a clinic environment. Examples of exercises could include ordering their regular coffee, common phrases used when buying items in stores, or introducing themselves. To monitor adherence to the intervention, the SW/AHA will complete a form after each intervention session to record that it occurred and whether there were any issues. SW/AHAs will be trained by Kinephonics staff prior to the intervention period, over 3 20-minute sessions. The SW/AHAs will learn how to use the Kinephonics technology, how to prepare the material and stimulus for each intervention session, and how to run a session with minimal assistance. The feasibility, acceptability, and adherence to completing the intervention with SW/AHAs for the purpose of conducting a larger clinical trial will be investigated as the primary outcome. Feasibility outcomes include participant fatigue, attendance rate to intervention sessions, and fidelity of intervention delivery is captured. Process evaluation interviews will also be conducted for an in-depth investigation of the trial feasibility with participants and SW/AHAs. Language outcomes before and after the intervention sessions will also be collected as secondary outcomes of this pilot trial. 20 participants with previous history of stroke will also be enrolled to complete 2 fMRI scans, one before the intervention and one after. These will be the first 20 eligible stroke participants who give consent to participate in fMRI component of the study. fMRI’s will be completed by the research staff of the Research Imaging NSW located at the Prince of Wales Hospital. This scan will take in total 60 minutes.

Sponsors

Kinephonics Trading Pty limited
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age 18 - 65 years * Receiving National Disability Insurance Scheme (NDIS) funding * Acquired or developmental communication disorders, caused by stroke, autism, cerebral palsy, intellectual or developmental disability, head injury, etc. * Chronic communication disorder - >6 months post acquired injury * English spoken as primary language * Access to smartphone or tablet * Provision of electronic informed consent

Exclusion criteria

* Sensory loss (hearing/vision) preventing participation in communication assessments and treatments * Acquired communication disorder diagnosed <6 months * Progressive neurological disease * Any other medical condition or disability, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant’s ability to cooperate or adhere to the protocol * Participation in any other impairment-based therapy for communication disorders (including alternative therapies and clinical trials) during the study period * Previous participation in Kinephonics intervention

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026