Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001160729
Ethics application status
Approved
Date submitted
16/08/2022
Date registered
24/08/2022
Date last updated
16/11/2023
Date data sharing statement initially provided
24/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
REmote Speech entrainment Therapy with people with long-term acquired and developmental communication disORdErs (RESTORE)
Scientific title
Feasibility of delivering REmote Speech entrainment Therapy with people with long-term acquired and developmental communication disORdErs (RESTORE)
Secondary ID [1] 307259 0
None
Universal Trial Number (UTN)
Trial acronym
RESTORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic communication disorder in adults 327148 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324283 324283 0 0
Speech therapy
Neurological 324529 324529 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324098 0
Rehabilitation
Intervention code [2] 324099 0
Treatment: Other
Comparator / control treatment
Active control group, in which participants will be randomised to the intervention phase or wait list group for the first 6 weeks. At week 7, participants will cross over and enter the intervention phase or wait list period for another 6 weeks. During the wait list period, participants will have no other speech therapy than the study intervention during the study period. Both groups will have study intervention. The difference is the timing of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 332093 0
The proportion of participants with satisfactory adherence to the intervention (attend at least 9 intervention sessions). The SW/AHA will be recording the number of sessions which the participants attend. Additionally, following the completion of the 16-week period, SW/AHAs will be asked to complete interviews about their views on the experience of the intervention, including adherence.
Timepoint [1] 332093 0
End of intervention phase - week 6 (intervention group) or week 12 (wait list group) post-randomisation
Primary outcome [2] 332094 0
Feasibility of recruitment and retention, measured by proportion of eligible patients who consent and proportion of participants with complete follow-ups assessed by an audit of study enrolment and the number of intervention sessions attended..
Timepoint [2] 332094 0
Eligible participants who consent will be measured at screening. Complete follow-ups will be measured at week 6 post baseline visit (for intervention group) and week 12 post baseline visit (for wait list group).
Primary outcome [3] 332095 0
Feasibility of delivering the intervention with SW/AHA measured by qualitative evaluation through semi-structured one-on-one audio-recorded interviews with a member of the research team and the SW/AHA and quantitative evaluation of the study-specific SW/AHA supervision questionnaire and study-specific training sessions. This is a composite outcome.
Timepoint [3] 332095 0
At the end of intervention phase - week 6 (intervention phase group) or week 12 (wait list group) post baseline visit
Secondary outcome [1] 412233 0
Changes in each language assessment task, assessed as a composite of: time of phrase completion, percent correct words, intelligibility, level of communication prompts, number of mazes, number of language errors, number of content units, number of syllables, number of syllables per content unit, number of turns taken within a conversation, measure of skill in supported conversation and measure of participation in conversation.
Timepoint [1] 412233 0
At baseline (week 0), week 6, week 12, and week 16 post-baseline visit
Secondary outcome [2] 412248 0
Change in brain activation observed using functional MRI before and after the intervention for stroke participants.
Timepoint [2] 412248 0
For intervention group: fMRI at week 0 and week 6 post-commencement
For wait list group: fMRI at week 6 and week 12 post-commencement
Secondary outcome [3] 412251 0
Participant self-rated fatigue level scale
Timepoint [3] 412251 0
Rated after each of the 12 intervention sessions
Secondary outcome [4] 412252 0
Serious adverse events will be reported by the participant, their family, or the support worker, to the research team, who will record this information in a study-specific questionnaire. Possible adverse events include any serious medical event (e.g. stroke, fall incident) which may occur during the study period, unrelated to the project. This is included as a result of a higher risk of accidents with this population.
Timepoint [4] 412252 0
Captured across the participant's study period (week 0 - week 16 post-baseline visit).
Secondary outcome [5] 413181 0
Additional primary outcome - Acceptability of research procedures and outcome measures determined by the assessment visit attendance rate and proportion of data completed for all outcome measures.
Timepoint [5] 413181 0
At screening, week 6, week 12, and week 16 post-baseline visit.
Secondary outcome [6] 413182 0
Additional primary outcome - Change in Mean Length of Utterance (MLU) of trained words/phrases after phase 1 in patients with developmental or acquired communication disorders.
MLU is a simple, standard speech pathology outcome measure to determine the complexity level of spontaneous speech. It was chosen for this project as a universal measure across all aetiologies of communication disorders, to identify any change in the length and/or complexity of spoken sentences before and after treatment (Stubbs et al., 2018; Condouris, Meyer, & Tager-Flusberg, 2003; Tager-Flusberg et al., 2009). It is calculated by counting the number of words per sentence and identifying the mean number of words across all sentences in a language sample.
Timepoint [6] 413182 0
At baseline, week 6, week 12, and week 16 post-baseline visit

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation allocation sequence is concealed by using electronic randomisation system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The assignment is similar to a crossover design, in which all participants will receive the intervention and are randomised if they are allocated to the wait list or intervention arm initially. However, the participants in the intervention arm who go on to the wait list at week 7 are not a standard 'control' group as they have previously received the language intervention.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
31/08/2022
Actual
23/02/2023
Date of last participant enrolment
Anticipated
15/03/2023
Actual
23/02/2023
Date of last data collection
Anticipated
3/07/2023
Actual
29/06/2023
Sample size
Target
50
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311556 0
Government body
Name [1] 311556 0
Australian Government Department of Industry, Science, Energy and Resources
Country [1] 311556 0
Australia
Funding source category [2] 312055 0
Other
Name [2] 312055 0
Brain Health Strategic Funding from The George Institute for Global Health
Country [2] 312055 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Kinephonics Trading Pty limited
Address
6 Gilderthorpe Avenue
Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 312971 0
Other
Name [1] 312971 0
The George Instittue for Global Health
Address [1] 312971 0
Level 5, 1 King Street
Newtown, NSW 2042
Country [1] 312971 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311006 0
Sydney Local Health District (RPAH Zone)
Ethics committee address [1] 311006 0
Ethics committee country [1] 311006 0
Australia
Date submitted for ethics approval [1] 311006 0
Approval date [1] 311006 0
16/07/2022
Ethics approval number [1] 311006 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119670 0
Prof Craig Anderson
Address 119670 0
The George Institute for Public Health
Level 5, 1 King Street
Newtown, NSW 2042
Country 119670 0
Australia
Phone 119670 0
+61 02 80524521
Fax 119670 0
Email 119670 0
canderson@georgeinstitute.org.au
Contact person for public queries
Name 119671 0
Molly Barnhart
Address 119671 0
The George Institute for Public Health
Level 5, 1 King Street
Newtown, NSW 2042
Country 119671 0
Australia
Phone 119671 0
+61 02 80524521
Fax 119671 0
Email 119671 0
mbarnhart@georgeinstitute.org.au
Contact person for scientific queries
Name 119672 0
Xiaoying Chen
Address 119672 0
The George Institute for Public Health
Level 5, 1 King Street
Newtown, NSW 2042
Country 119672 0
Australia
Phone 119672 0
+61 02 80524549
Fax 119672 0
Email 119672 0
xchen@georgeinstitute.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.