RecruitingACTRN12623000666628

Staying connected: Personalising stroke recovery and rehabilitation through new technologies for people with stroke living at home


Sponsor

Professor Leeanne Carey

Enrollment

312 participants

Start Date

Oct 11, 2023

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria24

  • 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

Exclusion Criteria15

  • 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:

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Interventions

Three participant groups are provided with interventions: 1. People with stroke 2. Therapists (occupational therapists and physiotherapists) 3. Therapy Buddies (people nominated by Stroke participa

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.


Locations(3)

John Hunter Hospital - New Lambton

NSW,SA,VIC, Australia

Austin Health - Austin Hospital - Heidelberg

NSW,SA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,SA,VIC, Australia

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ACTRN12623000666628


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