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Trial registered on ANZCTR


Registration number
ACTRN12623000666628
Ethics application status
Approved
Date submitted
4/04/2023
Date registered
20/06/2023
Date last updated
18/08/2024
Date data sharing statement initially provided
20/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Staying connected: Personalising stroke recovery and rehabilitation through new technologies for people with stroke living at home
Scientific title
Staying connected: Personalising stroke recovery and rehabilitation through new technologies for people with stroke living at home
Secondary ID [1] 309100 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TAILOR & CONNECT
(Therapy and Artificial Intelligence Linked to Optimise Rehabilitation & CONNECT with people living with stroke at home).
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 329175 0
Impaired functional use of the upper limb 329176 0
Condition category
Condition code
Stroke 326147 326147 0 0
Ischaemic
Stroke 327251 327251 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 327252 327252 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three participant groups are provided with interventions:
1. People with stroke
2. Therapists (occupational therapists and physiotherapists)
3. Therapy Buddies (people nominated by Stroke participants to assist them with therapy in the home environment under the direction of the Therapists)

Participant Group 1 (People with stroke)
Will participate in the study for a 12 month period, during which they will receive 2 periods of therapy (each period consisting of 10 sessions of approximately 1 hour over 6 weeks) of evidence-based upper limb therapy that is tailored to their identified goals. Dates of sessions and attendance will be recorded in the Individual Therapy Record, completed by the Therapist. Selection of therapy will be based on the developed MYPLAN approach. The MYPLAN approach involves the individual with stroke self-selecting real-world activities that they would like to improve their performance of. These activities form their identified goals. A n app-based publicly available algorithm (VIATHERAPY) is used to guide the therapist and the individual with stroke to an established evidence-based therapy that is best suited to achieve their identified goals, based on their clinical assessment findings combined with analysis of their current performance of these activities. Therapy options are based upon current best-practice evidence and clinical guidelines, and comprise: Mirror Therapy; Motor Imagery; SENSe Therapy; modified Constraint Induced Movement Therapy; Strength Training; Task Specific Training; and use of electrical stimulation to muscle groups (e-STIM). Therapy will be primarily delivered remotely via telehealth to the participant with stroke or in an environment of their choice. Any equipment that may be required for the selected therapy will be provided to the Participant with Stroke by the research team. In addition, participants in Group 1 (stroke survivors) will be stratified into one of two subgroups that are allocated based on entry into the study, i.e. the first 75 participants (1-75) will be in one subgroup, while the second 75 participants (76-150) will be in the other subgroup. Participants 1-75 will receive 2 therapy blocks during their 12 month involvement in the study at time periods that enable a spread of periods across the timeframe of the study for the subgroup. Participants 76-150 will receive 2 therapy blocks during their 12 involvement in the study as determined by the Growing Self-Organizing Maps (an Artificial Intelligence approach developed for predictive models of recovery) prediction algorithm.

Participant Group 2 (Therapists)
Occupational therapists and physiotherapists will be involved in an implementation intervention and will receive training in the MYPLAN approach and therapy selection algorithm (using the Via Therapy App that they will download to their phone to generate therapy options, and then using a paper-based document to select the therapy from this generated list of options). In addition, therapists will receive training in 8 established upper limb therapies (e.g. motor imagery, strength training, task specific training) that are evidence based and recommended in clinical guidelines. Training will be delivered using interactive workshops delivered online by trained clinical researchers and involving multimedia resources. Therapist training will commence on the Therapists entry into the study, and will be completed prior to the therapist commencing with their first participant with stroke.There will be 8 modules covered across the workshops that will vary in length between 2 and 6 hours, dependent on the content that is involved for training of the various therapies. The participants who are therapists will also receive supervision and mentoring throughout their involvement. The knowledge and skill of therapists will be measured before, during and after delivery of therapy and during the up-skilling process. Confidence and ability to deliver therapy remotely will be evaluated, and will include assessment of treatment fidelity. Treatment fidelity will include assessment by Therapy Trainers and video observation and analysis.

Participant Group 3 (Therapy Buddies)
Participants with stroke (Group 1) on entering into the study have the opportunity to nominate a person of their choice (Therapy Buddy) to assist them with the performing of any tasks required during the therapy sessions, under the direction of the Therapist. Therapy Buddies may also assist in practice sessions outside of the therapy sessions at the agreement of the Therapy Buddy and the Participant with Stroke for the amount of time and frequency determined by Therapy Buddy and Participant with Stroke. Therapy Buddies, if used, will be surveyed regarding their experiences in assisting with therapy in the study, and perceived benefit of therapy to the stroke survivor.
Intervention code [1] 325547 0
Rehabilitation
Comparator / control treatment
There will be 2 epochs of therapy (each 10 sessions over 6 weeks) during the Participants with Stroke involvement in the study (12 months), with a minimum of 6 weeks between therapy epochs. There will also be at least a 6 week period of usual care prior to intervention and prior to exiting at 12 months. Thus there will be 3 epochs of usual care (1 prior to therapy epoch 1; 1 between therapy epochs 1 and 2; and 1 post therapy epoch 2). Participants with Stroke will be divided into 2 subgroups, and timing of therapy epochs will be determined as described below:
Subgroup 1 (Recruited Participants with Stroke 1-75): Timing of 2 bursts of therapy (10 sessions over 6 weeks) will be delivered at times spread across the timeframe of the study for the subgroup, with a minimum of 6 weeks between each burst and at the beginning and end of the 12 month study duration

Subgroup 2 (Recruited Participants with Stroke 76-150): Timing of 2 bursts of therapy (10 sessions over 6 weeks) will be informed by the Growing Self-Organizing Maps (an Artificial Intelligence approach that will be used to capture the individuality of recovery across multiple domains, assessed by monitoring at standard recovery timepoints and change in performance associated with periods of therapy. Predictive models of recovery will be developed that combine personalised biopsychosocial measures with the person's experience of doing an activity to predict magnitude of improvement in self-selected real-world activities after stroke.

Participants with Stroke will be able to continue to access their usual services (including assisted care and external therapy, such as physiotherapy) at all times during their 12 month involvement in the study (covering both usual care epochs and therapy epochs). Usual services will be monitored using the Self-Reported Resource Use Tool (described in the Outcome Measures). The difference in the therapy epochs will be the provision of tailored therapy according to the MY PLAN approach.

Therapy Buddies will only participate in the study during the 2 therapy blocks. However, it is possible that the Therapy Buddy (who is nominated by the Participant with Stroke) may provide ongoing assistance as part of usual care.
Control group
Active

Outcomes
Primary outcome [1] 334074 0
Participants with Stroke: Performance in self-selected real-world activities, measured using the Canadian Occupational Performance Measure (COPM, a patient-reported measure, 10-point scale).
Timepoint [1] 334074 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Primary outcome [2] 334508 0
Performance in self-selected real-world activities, measured using the Performance Quality Rating Scale (PQRS, a therapist-rated measure, 10-point scale)
Timepoint [2] 334508 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [1] 419284 0
Participants with stroke: Use of the arm, measured by the Motor Activity Log.
Timepoint [1] 419284 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [2] 419285 0
Participants with Stroke: Motor skills. Assessed using the Action Research Arm Test (for grasp and release).
Timepoint [2] 419285 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [3] 419309 0
Participants with Stroke: Sensory discrimination skills, measured by the Tactile Discrimination Test (TDT).
Timepoint [3] 419309 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [4] 419310 0
Participants with Stroke: Transfer of training to untrained activities, measured using the Canadian Occupational Performance Measure COPM). This is the same measure that is used for the Primary outcome, but focus on activities not specifically trained.
Timepoint [4] 419310 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [5] 419557 0
Participants with stroke: Computer vision sensorimotor tasks.
These basic sensorimotor tasks, e.g., point, copy of hand/arm position, tracing an outline, object hit and avoid. These will be presented virtually and will permit calibration of movement capabilities for the self-selected real time activities.
Timepoint [5] 419557 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [6] 419558 0
Participants with Stroke: Pain Profile. Measured by the Margolis Pain Diagram (which will identify region of pain if present),
Timepoint [6] 419558 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Secondary outcome [7] 419559 0
Participants with Stroke: Fatigue.
Measured using the Fatigue Assessment Scale.
Timepoint [7] 419559 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Secondary outcome [8] 419560 0
Participants with Stroke: Stroke Impact
Measured by the Stroke Impact Scale.
Timepoint [8] 419560 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [9] 419561 0
Participants with Stroke: Self-reported Resource Use.
Measured by use of study-specific questionnaire that sources details re: use of community and private rehabilitation services, costs of rehabilitation provision at current clinical practice settings, productivity (ability to perform daily activities including leisure and work) or participants treated by the Therapy Centres.
Timepoint [9] 419561 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [10] 419562 0
Participants with Stroke: Cognition
Measured by the Montreal Cognitive Assessment (MoCA)
Timepoint [10] 419562 0
Baseline (entry) and exit (12-month post-entry).
Secondary outcome [11] 419563 0
Participants with Stroke: Anxiety and Mood.
Measured by the Hospital Anxiety and Depression Rating Scale.
Timepoint [11] 419563 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [12] 419564 0
Participants with Stroke: Severity of stroke.
Measured by the Modified Rankin Scale.
Timepoint [12] 419564 0
Assessed on entry into the study and at exit (12 months post-entry).
Secondary outcome [13] 419565 0
Participants with Stroke: Self-reported coping styles and self-efficacy.
Measured by the Stroke Self-Efficacy Questionnaire
Timepoint [13] 419565 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [14] 419566 0
Participants with Stroke: Readiness to engage in therapy.
Measured by the Readiness for Therapy Questionnaire
Timepoint [14] 419566 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [15] 419567 0
Participants with Stroke: Stress.
Measured by analysis of hair sample for cortisol levels.
Timepoint [15] 419567 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Secondary outcome [16] 419568 0
Participants with Stroke: Physical Activity.
Measured by the Rapid Assessment of Physical Activity (RAPA)
Timepoint [16] 419568 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Secondary outcome [17] 419569 0
Participants with Stroke: Real-time monitoring, via:
Personalised wearable sensors: (Actigraph GT9X Link) will monitor physiological variables, amount and frequency of physical activity, spontaneous arm use and sleep.
Timepoint [17] 419569 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Wearable sensors will be worn continually (as tolerated) through the monitoring period (5-7 days) for each assessment timepoint.
Monitoring via wearable sensors is also linked to therapy blocks (pre/commencement and post/completion) and will therefore enable monitoring during therapy and performing of the nominated activities to be trained in the therapy block.
Secondary outcome [18] 419570 0
Participants who are Therapy Buddies (i.e. those that may be assisting with the delivery of therapy to the Participant with Stroke): Therapy Buddy Satisfaction.
Measured by the Therapy Buddy Questionnaire, developed for this study, to source feedback from the Therapy Buddy regarding: their satisfaction with the level of information and training they are provided with prior to therapy; the therapy service provided; their confidence in assisting the delivery of therapy, and; the support they were provided with.
Timepoint [18] 419570 0
Assessed post therapy bursts.
Secondary outcome [19] 419571 0
Participants who are Therapy Buddies: Caregiver burden.
Measured by the Caregiver Burden Scale.
Timepoint [19] 419571 0
Assessed pre and post therapy bursts.
Secondary outcome [20] 419572 0
Participants who are Therapy Buddies: Perceived level of improvement in the Participant with Stroke's ability to perform their nominated real-world activities.
Measured by the Predictive Gains Question: “How effective do you think the therapy was in achieving improvement in the individuals nominated tasks performance?” (Not effective/Slightly effective/Moderately effective/Very effective).
Timepoint [20] 419572 0
Measured post therapy bursts.
Secondary outcome [21] 419573 0
Participants who are Therapists: Skills and Confidence to deliver Therapy.
Measured by the Therapist Baseline Skills and Confidence Questionnaire, developed for this study.
Timepoint [21] 419573 0
Therapists will complete the Questionnaire on entry into the study and at exit (on completion of the study).
Secondary outcome [22] 419574 0
Participants who are Therapists: Evaluation of Upskilling Program
Measured by the Therapist Upskilling Evalulation Questionnaire, developed for this study.
Timepoint [22] 419574 0
Therapists will complete the Therapist Upskilling Evaluation Questionnaire following completion of the upskilling program on entry into the study.
Secondary outcome [23] 419575 0
Participants who are Therapists: Therapist Reflection of the Therapy Program.
Therapists will complete the Therapy Program Reflection Document for each Participant with Stroke.
Timepoint [23] 419575 0
Therapists will complete the Therapy Program Reflection Document for each Participant with Stroke that they provide a therapy burst for, following each completed therapy program.
Secondary outcome [24] 419576 0
Participants who are Therapists: Perceived level of improvement in the Participant with Stroke's ability to perform their nominated real-world activities.
Measured by the Predictive Gains Question: “How effective do you think the therapy was in achieving improvement in the individuals nominated tasks performance?” (Not effective/Slightly effective/Moderately effective/Very effective).
Timepoint [24] 419576 0
Measured post therapy bursts
Secondary outcome [25] 419577 0
Participants who are Therapists: Treatment Fidelity
Measured by use of a developed Fidelity checklist, completed at time of observation of video of therapy session by Clinical Research Team Members.
Timepoint [25] 419577 0
Performed during and post therapy bursts.
Secondary outcome [26] 419578 0
Participants who are Therapists: Experiences in using the developed algorithm for therapy selection and experiences using a cognitive orientated approach.
This will be measured by use of focus groups to facilitate shared experiences.
Timepoint [26] 419578 0
Measured on entry into the study and on exit (completion of the study).
Secondary outcome [27] 420937 0
Participants with Stroke: Motor skills. Assessed using the Fugl-Meyer Test (for upper limb movements).
Timepoint [27] 420937 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [28] 420938 0
Participants with Stroke: Transfer of training to untrained activities, measured using the Performance Quality Rating Scale (PQRS). This is the same measure that is used for the Primary outcome, but focus on activities not specifically trained.
Timepoint [28] 420938 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [29] 420939 0
Participants with Stroke: Pain Profile. Measured by the Visual Analogue Scale for upper limb pain (a continuous scale from 0 no pain to 10 most pain possible).
Timepoint [29] 420939 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post entry).
Secondary outcome [30] 420940 0
Participants with Stroke: Pain Profile. Measured by the Neuropathic Pain Symptom Inventory (a series of pain symptoms that the participant is asked to score on a numerical rating scale of 0 - no pain symptom to 10 most pain symptom possible)
Timepoint [30] 420940 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post entry).
Secondary outcome [31] 420941 0
Participants with Stroke: Quality of Life.
Measured by the EuroQOL (EQ5D5L).
Timepoint [31] 420941 0
Baseline (entry), at two standard recovery time points post-stroke 93/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and at exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [32] 420942 0
Participants with Stroke: Real-time monitoring, via:
Experience Sampling Application: will capture perceived challenge and satisfaction during performance of daily acitivities and/or self-selected therapy activities, in addition to mood, fatigue, physical activity and social context.
Timepoint [32] 420942 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Experience sampling measures will be taken at random times in the day over the 5-7 day monitoring period. The Experience Sampling App will provide the client with 3-4 signals (beeps) per day during the monitoring period, followed by a brief (2-3 minutes) digital questionnaire assessment current state, perceived challenge and response to selected activities.
Monitoring via experience sampling is also linked to therapy blocks (pre/commencement and post/completion) and will therefore enable monitoring during therapy and performing of the nominated activities to be trained in the therapy block.
Secondary outcome [33] 421016 0
Participants with Stroke: Sensory discrimination skills, measured by the Wrist Position Sense Test (WPST)
Timepoint [33] 421016 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [34] 421017 0
Participants with Stroke: Sensory discrimination skills, measured by the functional Tactile Object Recognition Test (fTORT)
Timepoint [34] 421017 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.
Secondary outcome [35] 421018 0
Participants with Stroke: Goal driven attention and executive function.
Measured by the Trail Making Test A & B
Timepoint [35] 421018 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Secondary outcome [36] 421019 0
Participants with Stroke: Goal driven attention and executive function
Measured by the Digit Span Test)
Timepoint [36] 421019 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Secondary outcome [37] 422002 0
Cost-effectiveness: Cost (self-reported resource use) per Quality Adjusted Life Year (QALY; derived from EQ5D-5L).
Timepoint [37] 422002 0
Baseline (entry), at two standard recovery time points post-stroke (3/6/12/18/24/30 months post-stroke) that fall within the individuals 12 month involvement in the study, and exit (12 months post-entry).
Pre and post each therapy burst.

Eligibility
Key inclusion criteria
Key inclusion criteria are listed for the three groups of participants.

Participants with Stroke:
- Clinical diagnosis of stroke between 3 and 18 months prior to entry.
- Medically stable
- Able to give informed consent
- Comprehend simple instructions (follow stage 3 instructions and sustain attention for treatment - assessed at screening with adapted questions from the Mini Mental Stage Examination
- Willing to commit time to participate in the therapy program and monitoring process
- Living in the community
- May nominate to have access to a Therapy Buddy

Participants who are Therapy Buddies:
- Nominated by the stroke survivor as being able to assist in the delivery of therapy under the guidance of the TAILOR & CONNECT Therapist
- Medically stable
- Able to give informed consent
- Able to understand and speak English language, and, if appropriate, an ability to understand and speak the language of the participating stroke survivor if they are non-English speaking
- Able to be present/available during therapy sessions in the home
- Willing to commit time to participate in supporting delivery of the MY PLAN Therapy Program as a Therapy Buddy.

Participants who are Therapists:
- Qualified Occupational Therapist or Physiotherapist
- Registered to practice by the Australian Health Practitioner Regulation Agency
- Experience in stroke rehabilitation (minimum 6 months)
- Willing to participate in the upskilling program of the MYPLAN approach, including the therapy selection process and therapy delivery.
- Undertake evaluation and actively participate in mentoring in order to develop competency to successfully select and deliver therapy in accordance with the MY PLAN Therapy Program
- Willing to participate in intervention implementation activities, including questionnaires and focus groups.
- Able to understand and speak English language.
- Able to commit to delivery of upper limb therapy programs (10 sessions over 6 weeks) for participants with stroke, using the MYPLAN Therapy Approach and Therapy Selection Algoroithm
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants with Stroke:
- Not medically stable
- Severe unilateral spatial neglect, based on screening questions, clinical reports and/or standard neuropsychological tests (line bisection)
- Prior history of other central nervous system dysfunction with unstable or progressive prognosis
- Severe peripheral neuropathy in the upper limb
- Presence of moderate to severe cognitive impairment suggested through adapted Mini Mental State Examination questions
- Not able to comprehend simple instructions or sustained attention needed to particiapte in treatment (screened with adapted questions from the Mini Mental State Examination)
- Not able to give informed consent
- Physical limitations that prevent participation in therapy tasks (e.g., contracture of the hand, or unhealed wounds)
- Unable to participate in a clinical appointment lasting 30 minutes.

Participants who are Therapy Buddies:
- Not able to give informed consent
- Physical limitations that prevent the individual being able to assist the stroke survivor in the delivery of the Therapy Program
- Unable to commit to the necessary time required for the MY Plan Therapy Program

Participants who are Therapists:
There are no additional exclusion criteria for the participants who are therapists.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Participants with Stroke (Group 1) will be divided into 2 subgroups (determined by timing of enrolment into the study), and the timing of delivery of therapy will be determined based on each group as described below:

Subgroup 1 (Recruited Participants with Stroke 1-75): Timing of 2 bursts of therapy (10 sessions over 6 weeks) will be delivered at times spread across the timeframe of the study for the subgroup (12 months), with a minimum of 6 weeks usual care between each burst and at the beginning and end of the 12 month study duration.

Subgroup 2 (Recruited Participants with Stroke 76-150): Timing of 2 bursts of therapy (10 sessions over 6 weeks) will be informed by the Growing Self-Organizing Maps (an Artificial Intelligence approach that will be used to capture the individuality of recovery across multiple domains, assessed by monitoring at standard recovery timepoints and change in performance associated with periods of therapy. Predictive models of recovery will be developed that combine personalised biopsychosocial measures with the person's experience of doing an activity to predict magnitude of improvement in self-selected real-world activities after stroke.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed to examine:

for Stroke Survivors
1) Improvement in real world activities. Pre-post changes in the primary outcomes (performance rating in real-world activities, 20 point scale) will be determined during bursts of therapy (2 epochs) and compared to usual care (3 epochs). We will model how bursts of therapy disrupt the trend for recovery. A family of planned comparisons will compare if the level (magnitude) and slope (rate) of change is greater across the intervention epochs, when adjusted for the change expected from the prior trend. Latency (post-stroke and duration of usual care epochs vary and will also be adjusted for. Both mean changes associated with therapy, and individual changes expressed as functions of minimal clinically significant change, will be evaluated.

2) Real time monitoring. Each person's recovery trajectory will be monitored on 7-8 occasions over the 12-month enrolment period, i.e. at baseline; at standard times post-stroke (2 occasions); pre post therapy bursts (4 occasions); and at end of study period. The Artificial Intelligence approach (Growing Self Organizing Maps) will be used to capture the individuality of recovery across multiple domains. We will develop predictive models of recovery that combine personalised biopsychosocial measures with the person's experience of doing a task and tests its ability to predict magnitude of improvement in self-selected real-world activities after stroke.

3) Magnitude of change in sensorimotor function. The magnitude of therapeutic change in sensorimotor function pre-post therapy blocks will be determined as an effect size and compared to benchmark effect sizes obtained in previous controlled studies for the specific therapy delivered. Statistical estimates of change will employ 95% confidence intervals. Sustainability of the intervention effect will be evaluated via the assessment schedule.

For All Participants (Stroke Survivors, TAILOR and CONNECT Therapists, and Therapy Buddies):
4) Input from stroke survivors, therapy buddies and TAILOR and CONNECT therapist. Data from questionnaires will be summarized and categorised into themes using qualitative methods.

For Therapists:
5) Implementation and Treatment Fidelity. High fidelity delivery will be defined as a score of 80% or higher on treatment fidelity checklists. Audit data will be summarized and compared across deliveries. Pre and post-test questionnaires of knowledge, confidence, and ability to deliver MYPLAN therapy program remotely will be examined. Response tendencies will be analysed using contingency tables, chi-square and graphical representation. Focus group information will be analyzed thematically withj assistance of the qualitative software package NVivo10.

Economics:
6) Economic evaluation. Economic costs associated with delivery of bursts of therapy, in particular the costs of up-skilling therapists in the selection and delivery of the clinical interventions, will be determined. Outcomes and resource use of patients participating in therapy will be compared to those in current clinical practice and home settings and during usual care monitoring periods. The incremental cost-effectiveness of bursts of TAILOR and CONNECT therapy compared to usual care will be evaluated. The cost per unit of improvement in the primary outcome (performance in self-selected activity) will be reported, with incremental cost-effectiveness ratios reported as net costs per unit of improvement. Quality adjusted life years will be estimated based on responses to the EQ5D-5L provided by participants at each assessment in TAILOR and CONNECT Therapy Centres. This instrument has been validated for patients with stroke.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/07/2023
Actual
11/10/2023
Date of last participant enrolment
Anticipated
11/07/2026
Actual
Date of last data collection
Anticipated
11/07/2027
Actual
Sample size
Target
312
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 24288 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 24356 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 24357 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 39939 0
2305 - New Lambton
Recruitment postcode(s) [2] 39940 0
3084 - Heidelberg
Recruitment postcode(s) [3] 39941 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 313303 0
Government body
Name [1] 313303 0
National Health and Medical Research Council (NHMRC) Ideas Grant
Country [1] 313303 0
Australia
Primary sponsor type
Individual
Name
Professor Leeanne Carey
Address
School of Allied Health, Human Services and Sport
La Trobe University
Kingsbury Drive
Bundoora Vic 3086
Country
Australia
Secondary sponsor category [1] 315046 0
University
Name [1] 315046 0
La Trobe University
Address [1] 315046 0
Research Office
La Trobe University
Kingsbury Drive
Bundoora Vic 3086
Country [1] 315046 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312529 0
Austin Human Research Ethics Committee
Ethics committee address [1] 312529 0
145 Studley Road
Heidelberg, Vic 3084
Ethics committee country [1] 312529 0
Australia
Date submitted for ethics approval [1] 312529 0
13/09/2022
Approval date [1] 312529 0
22/02/2023
Ethics approval number [1] 312529 0
HREC/89411/Austin-2022

Summary
Brief summary
A large proportion of stroke survivors return to living in the community with chronic and complex health needs that are often left unmet. This can have a devastating and long-term impact on their health and productivity. Current stroke rehabilitation is typically hospital-based, time-limited, and applies standard therapy despite variable outcomes. However, there is a gap in transfer of gains to activities the person needs and wants to do at home, and individual recovery trajectories are often disrupted by the lack of tailored professional services to support mid and long-term recovery. This study aims to bridge this gap.
We propose a solution to address the individual complexity of recovery over time, delivery therapy at the time of need in the community, and utilise new technologies to monitor and give interactive feedback, to enhance productivity goals. Our approach utilises 3 key points of innovation which are operationalised for persons with stroke living at home.
First is monitoring the person in real-time in their home environment, using personalised wearable sensors and an application to survey the experience of engaging in daily activities, in order to determine biopsychosocial markers of recovery and rehabilitation and to inform personalised needs and capacity.
Second is the provision of bursts of evidence-based therapies in the community that are personalised, goal-directed for real-world activities, and enhanced to give feedback through a therapist avatar.
This is the formation of a centralised hub with an interactive database informed by artificial intelligence. This hub will be supported by a network of sites and up-skilled therapists to support delivery of personalised best practice therapy: at the right time and right place.
Our target is improved performance in real-world activities and quality of life of persons with stroke living in the community. Significance lies in establishing evidence for a shift in practice that guides personalised rehabilitation in the long-term, at home, and supported by new technologies to stay connected.
We hypothesise that individuals with stroke living in the community will demonstrate significant improvements in their performance of self-selected, real -world activities following bursts of personalised rehabilitation that includes the use of technology-enhanced remote feedback.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124986 0
Prof Leeanne Carey
Address 124986 0
Occupational Therapy
School of Allied Health, Human Services and Sport
La Trobe University
Kingsbury Drive
Bundoora, Vic 3086
Country 124986 0
Australia
Phone 124986 0
+61 3 9479 5600
Fax 124986 0
+61 3 94975737
Email 124986 0
[email protected]
Contact person for public queries
Name 124987 0
Brendon Haslam
Address 124987 0
Occupational Therapy
School of Allied Health, Human Services and Sport
La Trobe University
Kingsbury Drive
Bundoora, Vic 3086
Country 124987 0
Australia
Phone 124987 0
+61 4 38323006
Fax 124987 0
+61 3 94975737
Email 124987 0
[email protected]
Contact person for scientific queries
Name 124988 0
Leeanne Carey
Address 124988 0
Occupational Therapy
School of Allied Health, Human Services and Sport
La Trobe University
Kingsbury Drive
Bundoora, Vic 3086
Country 124988 0
Australia
Phone 124988 0
+61 3 9479 5600
Fax 124988 0
+61 3 94975737
Email 124988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing of personal participant data was not included in the approved ethics application to Austin Health HREC.
We will endeavour to share non-identifiable non-raw data (i.e. semi-analysed de-identified) upon request wherever possible, providing it is consistent with the approved ethics.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18729Other    Recruitment Poster 385482-(Uploaded-28-03-2023-12-20-48)-Study-related document.pdf



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.