xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05981729</url>
    </required_header>
    <id_info>
      <org_study_id>IAA_UoS/KerrBME/2023</org_study_id>
      <nct_id>NCT05981729</nct_id>
    </id_info>
    <brief_title>Technology Enriched Stroke Rehabilitation in Acute/Sub-acute Stroke</brief_title>
    <official_title>Feasibility of Inpatient Technology Enriched Stroke Rehabilitation During the Acute and Sub-acute Phase After Stroke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Strathclyde</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>NHS Lanarkshire</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Strathclyde</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Delivery of intensive rehabilitation plays an important part within stroke care and has the&#xD;
        potential to affect rates of recovery and optimise outcomes as part of a wider&#xD;
        multidisciplinary approach. New and innovative models of rehabilitation delivery are needed&#xD;
        in order to bridge the gap between current staffing resources and recommended levels of&#xD;
        rehabilitation intensity.&#xD;
  &#xD;
        This study looks to investigate the feasibility and acceptability of such a model, using&#xD;
        rehabilitation technology to enrich and enhance delivery of rehabilitation within an NHS&#xD;
        inpatient stroke unit environment. This model of rehabilitation delivery has already been&#xD;
        tested by the research team with community-dwelling participants in the chronic phase of&#xD;
        stroke (over a year since stroke) and is known to be feasible and safe. Participants will be&#xD;
        recruited from the stroke unit at University Hospital Wishaw during the acute and sub-acute&#xD;
        phase of stroke (0-6 months since stroke), if requiring rehabilitation following a stroke and&#xD;
        deemed medically fit enough to participate. Participants will be supported to complete&#xD;
        activities in a newly dedicated 'technology enriched rehabilitation space' by NHS staff, in&#xD;
        addition to their usual treatment. This will enable participants to engage in rehabilitation&#xD;
        activities relating to their physical, cognitive, visual, communication and functional goals&#xD;
        using equipment such as an adapted treadmill, interactive screens and tablets, upper limb&#xD;
        exercise devices, power-assisted gym equipment and virtual reality. All devices are&#xD;
        commercially available and known to be safe for use with stroke patients, however the use of&#xD;
        such devices within NHS services is currently known to be under-utilised. Data will be&#xD;
        obtained through a range of measures to monitor safety (incidence and types of adverse&#xD;
        events), adherence (sessions/time attended, movement repetitions) and through interviews with&#xD;
        participants, their family/carers, and staff to understand user acceptability.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Scottish Stroke Improvement Programme identifies stroke as the most common cause of&#xD;
        severe physical disability amongst Scottish adults. Hospital care for these patients accounts&#xD;
        for 7% of all NHS beds and 5% of the entire NHS budget. Furthermore, the number of strokes&#xD;
        across the UK is projected to increase by 60% between 2015 and 2035.&#xD;
  &#xD;
        Rehabilitation delivered by a multi-disciplinary team including Allied Health Professionals&#xD;
        (occupational therapists [OT's], physiotherapists [PT's], and speech and language therapists&#xD;
        [SLT's]) is known to improve functional recovery after stroke, particularly if it can be&#xD;
        applied intensively and within enriched, stimulating environments. It is widely accepted that&#xD;
        greater intensity, or dose, of rehabilitation improves outcomes and leads to greater and&#xD;
        faster improvement of activities after stroke. However, a large gap exists between the&#xD;
        minimum recommendations for stroke rehabilitation (three hours of multidisciplinary therapy a&#xD;
        day, at least 5 days out of 7) and what the NHS are currently able to provide, given the&#xD;
        majority of in-patient stroke units are operating below the staffing levels recommended in&#xD;
        national clinical guidelines, and are therefore challenged to provide the amount of therapy&#xD;
        to facilitate optimum recovery for stroke patients. An analysis of data from the UK Sentinel&#xD;
        Stroke National Audit Programme found, on average, patients who required specific therapy&#xD;
        following stroke received around 14 minutes of PT, 13 minutes of OT, and 7 minutes of SLT per&#xD;
        day of inpatient stay. Therefore, new and innovative models of rehabilitation delivery are&#xD;
        needed in order to bridge the gap between current staffing resources and recommended levels&#xD;
        of rehabilitation intensity.&#xD;
  &#xD;
        Commercially available technology, such as robotics, adapted treadmills, virtual reality, and&#xD;
        mobile digital devices such as smartphones, tablets and wearable sensors, have been shown to&#xD;
        be a safe and feasible method of increasing rehabilitation intensity, under the prescription&#xD;
        and supervision of therapy staff. It can be used to enhance usual therapy and can allow&#xD;
        stroke patients to work on physical, cognitive, visual, and communication goals, without&#xD;
        one-to-one or 'hands on' treatment from a therapist. Despite the potential offered by&#xD;
        rehabilitation technology to help deliver evidence-based levels of practice intensity and&#xD;
        automated feedback without additional labour costs, currently few technologies have been&#xD;
        adopted into everyday rehabilitation.&#xD;
  &#xD;
        A well-established research group at the University of Strathclyde (UoS) Biomedical&#xD;
        Engineering department have been developing and testing a technology-based, holistic model as&#xD;
        a possible solution to the gap between clinical need and current provision. The technology&#xD;
        enriched rehabilitation model has been tested under controlled conditions with chronic stroke&#xD;
        survivors (at least one year post stroke) and shown to be feasible. While this model presents&#xD;
        a potential method of scaling up rehabilitation delivery, and has been successfully deployed&#xD;
        and tested for feasibility with chronic stroke, it not yet been evaluated for acute and&#xD;
        sub-acute stroke patients or tested for clinical acceptability. This specific population has&#xD;
        greater potential for recovery as the brain is more receptive to recovery through structural&#xD;
        changes to neural pathways (neuroplasticity), therefore delivering higher intensity&#xD;
        rehabilitation is therefore more critical at this phase of rehabilitation.&#xD;
  &#xD;
        Recently, an NHSL occupational therapy advanced practitioner has been seconded into a&#xD;
        research post within the UoS Biomedical Engineering department. This has created greater&#xD;
        opportunity for collaboration between the research team at UoS and NHS Lanarkshire, to test&#xD;
        this technology delivered rehabilitation model within an acute stroke unit where the impact&#xD;
        of enhanced rehabilitation is likely to be greater. The Director of Hospital Services at&#xD;
        University Hospital Wishaw (UHW) has expressed support for a technology enriched stroke&#xD;
        rehabilitation model to be tested within the stroke unit on site and has provided a large&#xD;
        room within the ward that can be made available for equipment (loaned from the University of&#xD;
        Strathclyde and UK manufacturer Innerva) to be housed and used by patients under supervision&#xD;
        from NHS staff. Funding has been secured for research assistant time from the UoS in order to&#xD;
        support the introduction of the technology and to complete data collection. Participants will&#xD;
        be supported to use the rehabilitation technology by trained NHS staff.&#xD;
  &#xD;
        This is a mixed methods feasibility study in line with Medical Research Council&#xD;
        recommendations for development of a complex intervention.The methodology of the study is as&#xD;
        follows;&#xD;
  &#xD;
          -  Inpatients on the stroke unit, with a diagnosis of stroke, at University Hospital&#xD;
             Wishaw, Scotland, will be assessed for eligibility by the NHS multidisciplinary team&#xD;
             using the inclusion/exclusion criteria.&#xD;
  &#xD;
          -  Patients who have been identified as medically fit for rehabilitation and who fit the&#xD;
             criteria for the study shall be highlighted to the research assistant by the NHS&#xD;
             medical/therapy team. The researcher shall then check with the relevant members of the&#xD;
             multi-disciplinary team that all inclusion/exclusion criteria are met before approaching&#xD;
             the patient.&#xD;
  &#xD;
          -  The Participant Information Sheet and link to a supporting YouTube video with info on&#xD;
             the study shall be supplied to the patient by the research assistant and an opportunity&#xD;
             shall be offered for any questions from the patient and their family/carers if&#xD;
             appropriate, with the patients consent. Informed consent shall then be taken by a&#xD;
             University of Strathclyde research assistant only.&#xD;
  &#xD;
          -  Participants will be supported to access and use the rehabilitation technology, in&#xD;
             addition to usual care, by NHS staff. This will involve the prescription of a&#xD;
             rehabilitation technology programme by the NHS physiotherapists, occupational therapists&#xD;
             and speech and language therapists, following usual care assessment. This is with an aim&#xD;
             to increase rehabilitation activity within the participant's capacity, taking into&#xD;
             account their level of impairment and fatigue. Therefore, time spent using the&#xD;
             rehabilitation technology will be varied and tailored to meet the participant's needs.&#xD;
             The dose and intensity of technology enriched rehabilitation will be measured and&#xD;
             recorded, however will not be controlled for these reasons.&#xD;
  &#xD;
          -  The Principal Investigator (NHS occupational therapist) will hold weekly meetings with&#xD;
             the ward therapy staff to discuss any concerns around the study or regarding participant&#xD;
             programmes and will liaise directly with the research assistant as appropriate.&#xD;
  &#xD;
          -  Data collection/outcome measures will be completed as detailed in following sections.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Feasibility study with convenience sample. All in patients with diagnosis of stroke and who fit criteria will be offered intervention.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Duration of time spent on activities within the 'technology enriched rehabilitation space'</measure>
      <time_frame>1 year</time_frame>
      <description>Time in minutes will be measured in which participants spent on activities within the 'technology enriched rehabilitation space'</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Movement repetitions</measure>
      <time_frame>1 year</time_frame>
      <description>Number of movement repetitions completed within 'technology enriched rehabilitation' sessions will be measured by use of wearable activity monitors (armbands)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rates of recruitment and attrition</measure>
      <time_frame>1 year</time_frame>
      <description>Percentage of eligible individual consenting to participate and percentage of people dropping/opting out before discharge.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence to sessions</measure>
      <time_frame>1 year</time_frame>
      <description>Number of sessions attended as a percentage of those available/targeted</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intervention Acceptability</measure>
      <time_frame>1 year</time_frame>
      <description>Audio-recorded semi-structured interviews will be completed with participants, family/carers and NHS staff. These interviews will be completed by a UoS research assistant. The questions posed during these interviews will focus on collecting qualitative data on the acceptability of the intervention. These shall be transcribed and thematic analysis will be used to analyse this data.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>Technology enhanced stroke rehabilitation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Supported use of stroke rehabilitation technology</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Technology enriched stroke rehabilitation</intervention_name>
      <description>In order to increase time spent in rehabilitation activity, participants will be prescribed and supported to use (by NHS staff) commercially available technology, such as robotics, adapted treadmills, virtual reality, and mobile digital devices such as smartphones, tablets, and wearable sensors.</description>
      <arm_group_label>Technology enhanced stroke rehabilitation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of new stroke by NHS Lanarkshire physician&#xD;
  &#xD;
            -  More than 48 hours since stroke event&#xD;
  &#xD;
            -  Deemed medically fit for rehabilitation by medical staff&#xD;
  &#xD;
            -  Deemed to require rehabilitation&#xD;
  &#xD;
            -  Able to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acutely medically unwell&#xD;
  &#xD;
            -  Active cardiac disease, such as unstable angina&#xD;
  &#xD;
            -  Active delirium/significant levels of confusion&#xD;
  &#xD;
            -  Seizure within past 7 days&#xD;
  &#xD;
            -  Individual currently being managed under the Adults with Incapacity Act&#xD;
  &#xD;
            -  Known pregnancy&#xD;
  &#xD;
            -  Unable to follow verbal, written or gestured basic instructions&#xD;
  &#xD;
            -  Excessive pain or tonal issues which are deemed to contraindicate inclusion by&#xD;
               medical/therapy team&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gillian Sweeney, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>South Health &amp; Social Care Partnership</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gillian Sweeney, PhD</last_name>
      <phone>01698754555</phone>
      <email>gillian.sweeney@lanarkshire.scot.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Andrew Kerr, PhD</last_name>
      <phone>01415482855</phone>
      <email>a.kerr@strath.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital Wishaw</name>
        <address>
          <city>Wishaw</city>
          <state>Lanarkshire</state>
          <zip>ML2 0DP</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Gillian Sweeney, PhD</last_name>
        <phone>01698 754555</phone>
        <email>gillian.sweeney@lanarkshire.scot.nhs.uk</email>
      </contact>
      <contact_backup>
        <last_name>Andrew Kerr, PhD</last_name>
        <phone>01415482855</phone>
        <email>a.kerr@strath.ac.uk</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <reference>
      <citation>King D, Wittenberg R, Patel A, Quayyum Z, Berdunov V, Knapp M. The future incidence, prevalence and costs of stroke in the UK. Age Ageing. 2020 Feb 27;49(2):277-282. doi: 10.1093/ageing/afz163.</citation>
      <PMID>31957781</PMID>
    </reference>
    <reference>
      <citation>Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.</citation>
      <PMID>19608100</PMID>
    </reference>
    <reference>
      <citation>Gittins M, Vail A, Bowen A, Lugo-Palacios D, Paley L, Bray B, Gannon B, Tyson S. Factors influencing the amount of therapy received during inpatient stroke care: an analysis of data from the UK Sentinel Stroke National Audit Programme. Clin Rehabil. 2020 Jul;34(7):981-991. doi: 10.1177/0269215520927454. Epub 2020 Jun 7.</citation>
      <PMID>32508132</PMID>
    </reference>
    <reference>
      <citation>Kwakkel G, Kollen BJ. Predicting activities after stroke: what is clinically relevant? Int J Stroke. 2013 Jan;8(1):25-32. doi: 10.1111/j.1747-4949.2012.00967.x.</citation>
      <PMID>23280266</PMID>
    </reference>
    <reference>
      <citation>Warland A, Paraskevopoulos I, Tsekleves E, Ryan J, Nowicky A, Griscti J, Levings H, Kilbride C. The feasibility, acceptability and preliminary efficacy of a low-cost, virtual-reality based, upper-limb stroke rehabilitation device: a mixed methods study. Disabil Rehabil. 2019 Sep;41(18):2119-2134. doi: 10.1080/09638288.2018.1459881. Epub 2018 Apr 12.</citation>
      <PMID>29644897</PMID>
    </reference>
    <reference>
      <citation>Schroder J, van Criekinge T, Embrechts E, Celis X, Van Schuppen J, Truijen S, Saeys W. Combining the benefits of tele-rehabilitation and virtual reality-based balance training: a systematic review on feasibility and effectiveness. Disabil Rehabil Assist Technol. 2019 Jan;14(1):2-11. doi: 10.1080/17483107.2018.1503738. Epub 2018 Oct 14.</citation>
      <PMID>30318952</PMID>
    </reference>
    <reference>
      <citation>Kerr A, Smith M, Reid L, Baillie L. Adoption of Stroke Rehabilitation Technologies by the User Community: Qualitative Study. JMIR Rehabil Assist Technol. 2018 Aug 17;5(2):e15. doi: 10.2196/rehab.9219.</citation>
      <PMID>30120086</PMID>
    </reference>
    <reference>
      <citation>Kerr A, Keogh M, Slachetka M, Grealy M, Rowe P. An Intensive Exercise Program Using a Technology-Enriched Rehabilitation Gym for the Recovery of Function in People With Chronic Stroke: Usability Study. JMIR Rehabil Assist Technol. 2023 Jul 21;10:e46619. doi: 10.2196/46619.</citation>
      <PMID>37477954</PMID>
    </reference>
    <reference>
      <citation>National Clinical Guideline for Stroke for the UK and Ireland, 2023 edition. Royal College of Physicians, London UK.</citation>
    </reference>
    <reference>
      <citation>Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.</citation>
      <PMID>34593508</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Strathclyde</investigator_affiliation>
      <investigator_full_name>Gillian Sweeney</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05981729
  org study id: IAA_UoS/KerrBME/2023
  nct id: NCT05981729
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Delivery of intensive rehabilitation plays an important part within stroke care and has the
        potential to affect rates of recovery and optimise outcomes as part of a wider
        multidisciplinary approach. New and innovative models of rehabilitation delivery are needed
        in order to bridge the gap between current staffing resources and recommended levels of
        rehabilitation intensity.
  
        This study looks to investigate the feasibility and acceptability of such a model, using
        rehabilitation technology to enrich and enhance delivery of rehabilitation within an NHS
        inpatient stroke unit environment. This model of rehabilitation delivery has already been
        tested by the research team with community-dwelling participants in the chronic phase of
        stroke (over a year since stroke) and is known to be feasible and safe. Participants will be
        recruited from the stroke unit at University Hospital Wishaw during the acute and sub-acute
        phase of stroke (0-6 months since stroke), if requiring rehabilitation following a stroke and
        deemed medically fit enough to participate. Participants will be supported to complete
        activities in a newly dedicated 'technology enriched rehabilitation space' by NHS staff, in
        addition to their usual treatment. This will enable participants to engage in rehabilitation
        activities relating to their physical, cognitive, visual, communication and functional goals
        using equipment such as an adapted treadmill, interactive screens and tablets, upper limb
        exercise devices, power-assisted gym equipment and virtual reality. All devices are
        commercially available and known to be safe for use with stroke patients, however the use of
        such devices within NHS services is currently known to be under-utilised. Data will be
        obtained through a range of measures to monitor safety (incidence and types of adverse
        events), adherence (sessions/time attended, movement repetitions) and through interviews with
        participants, their family/carers, and staff to understand user acceptability.
  The Scottish Stroke Improvement Programme identifies stroke as the most common cause of
        severe physical disability amongst Scottish adults. Hospital care for these patients accounts
        for 7% of all NHS beds and 5% of the entire NHS budget. Furthermore, the number of strokes
        across the UK is projected to increase by 60% between 2015 and 2035.
  
        Rehabilitation delivered by a multi-disciplinary team including Allied Health Professionals
        (occupational therapists [OT's], physiotherapists [PT's], and speech and language therapists
        [SLT's]) is known to improve functional recovery after stroke, particularly if it can be
        applied intensively and within enriched, stimulating environments. It is widely accepted that
        greater intensity, or dose, of rehabilitation improves outcomes and leads to greater and
        faster improvement of activities after stroke. However, a large gap exists between the
        minimum recommendations for stroke rehabilitation (three hours of multidisciplinary therapy a
        day, at least 5 days out of 7) and what the NHS are currently able to provide, given the
        majority of in-patient stroke units are operating below the staffing levels recommended in
        national clinical guidelines, and are therefore challenged to provide the amount of therapy
        to facilitate optimum recovery for stroke patients. An analysis of data from the UK Sentinel
        Stroke National Audit Programme found, on average, patients who required specific therapy
        following stroke received around 14 minutes of PT, 13 minutes of OT, and 7 minutes of SLT per
        day of inpatient stay. Therefore, new and innovative models of rehabilitation delivery are
        needed in order to bridge the gap between current staffing resources and recommended levels
        of rehabilitation intensity.
  
        Commercially available technology, such as robotics, adapted treadmills, virtual reality, and
        mobile digital devices such as smartphones, tablets and wearable sensors, have been shown to
        be a safe and feasible method of increasing rehabilitation intensity, under the prescription
        and supervision of therapy staff. It can be used to enhance usual therapy and can allow
        stroke patients to work on physical, cognitive, visual, and communication goals, without
        one-to-one or 'hands on' treatment from a therapist. Despite the potential offered by
        rehabilitation technology to help deliver evidence-based levels of practice intensity and
        automated feedback without additional labour costs, currently few technologies have been
        adopted into everyday rehabilitation.
  
        A well-established research group at the University of Strathclyde (UoS) Biomedical
        Engineering department have been developing and testing a technology-based, holistic model as
        a possible solution to the gap between clinical need and current provision. The technology
        enriched rehabilitation model has been tested under controlled conditions with chronic stroke
        survivors (at least one year post stroke) and shown to be feasible. While this model presents
        a potential method of scaling up rehabilitation delivery, and has been successfully deployed
        and tested for feasibility with chronic stroke, it not yet been evaluated for acute and
        sub-acute stroke patients or tested for clinical acceptability. This specific population has
        greater potential for recovery as the brain is more receptive to recovery through structural
        changes to neural pathways (neuroplasticity), therefore delivering higher intensity
        rehabilitation is therefore more critical at this phase of rehabilitation.
  
        Recently, an NHSL occupational therapy advanced practitioner has been seconded into a
        research post within the UoS Biomedical Engineering department. This has created greater
        opportunity for collaboration between the research team at UoS and NHS Lanarkshire, to test
        this technology delivered rehabilitation model within an acute stroke unit where the impact
        of enhanced rehabilitation is likely to be greater. The Director of Hospital Services at
        University Hospital Wishaw (UHW) has expressed support for a technology enriched stroke
        rehabilitation model to be tested within the stroke unit on site and has provided a large
        room within the ward that can be made available for equipment (loaned from the University of
        Strathclyde and UK manufacturer Innerva) to be housed and used by patients under supervision
        from NHS staff. Funding has been secured for research assistant time from the UoS in order to
        support the introduction of the technology and to complete data collection. Participants will
        be supported to use the rehabilitation technology by trained NHS staff.
  
        This is a mixed methods feasibility study in line with Medical Research Council
        recommendations for development of a complex intervention.The methodology of the study is as
        follows;
  
          -  Inpatients on the stroke unit, with a diagnosis of stroke, at University Hospital
             Wishaw, Scotland, will be assessed for eligibility by the NHS multidisciplinary team
             using the inclusion/exclusion criteria.
  
          -  Patients who have been identified as medically fit for rehabilitation and who fit the
             criteria for the study shall be highlighted to the research assistant by the NHS
             medical/therapy team. The researcher shall then check with the relevant members of the
             multi-disciplinary team that all inclusion/exclusion criteria are met before approaching
             the patient.
  
          -  The Participant Information Sheet and link to a supporting YouTube video with info on
             the study shall be supplied to the patient by the research assistant and an opportunity
             shall be offered for any questions from the patient and their family/carers if
             appropriate, with the patients consent. Informed consent shall then be taken by a
             University of Strathclyde research assistant only.
  
          -  Participants will be supported to access and use the rehabilitation technology, in
             addition to usual care, by NHS staff. This will involve the prescription of a
             rehabilitation technology programme by the NHS physiotherapists, occupational therapists
             and speech and language therapists, following usual care assessment. This is with an aim
             to increase rehabilitation activity within the participant's capacity, taking into
             account their level of impairment and fatigue. Therefore, time spent using the
             rehabilitation technology will be varied and tailored to meet the participant's needs.
             The dose and intensity of technology enriched rehabilitation will be measured and
             recorded, however will not be controlled for these reasons.
  
          -  The Principal Investigator (NHS occupational therapist) will hold weekly meetings with
             the ward therapy staff to discuss any concerns around the study or regarding participant
             programmes and will liaise directly with the research assistant as appropriate.
  
          -  Data collection/outcome measures will be completed as detailed in following sections.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Feasibility study with convenience sample. All in patients with diagnosis of stroke and who fit criteria will be offered intervention.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Duration of time spent on activities within the 'technology enriched rehabilitation space'
  time frame: 1 year
  description: Time in minutes will be measured in which participants spent on activities within the 'technology enriched rehabilitation space'
  measure: Movement repetitions
  time frame: 1 year
  description: Number of movement repetitions completed within 'technology enriched rehabilitation' sessions will be measured by use of wearable activity monitors (armbands)
  measure: Rates of recruitment and attrition
  time frame: 1 year
  description: Percentage of eligible individual consenting to participate and percentage of people dropping/opting out before discharge.
  measure: Adherence to sessions
  time frame: 1 year
  description: Number of sessions attended as a percentage of those available/targeted
  measure: Intervention Acceptability
  time frame: 1 year
  description: Audio-recorded semi-structured interviews will be completed with participants, family/carers and NHS staff. These interviews will be completed by a UoS research assistant. The questions posed during these interviews will focus on collecting qualitative data on the acceptability of the intervention. These shall be transcribed and thematic analysis will be used to analyse this data.
  arm group label: Technology enhanced stroke rehabilitation
  arm group type: Experimental
  description: Supported use of stroke rehabilitation technology
  intervention type: Other
  intervention name: Technology enriched stroke rehabilitation
  description: In order to increase time spent in rehabilitation activity, participants will be prescribed and supported to use (by NHS staff) commercially available technology, such as robotics, adapted treadmills, virtual reality, and mobile digital devices such as smartphones, tablets, and wearable sensors.
  arm group label: Technology enhanced stroke rehabilitation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Gillian Sweeney, PhD
  role: Principal Investigator
  affiliation: South Health & Social Care Partnership
  last name: Gillian Sweeney, PhD
  phone: 01698754555
  email: gillian.sweeney@lanarkshire.scot.nhs.uk
  last name: Andrew Kerr, PhD
  phone: 01415482855
  email: a.kerr@strath.ac.uk
  facility: 
  contact: 
  contact backup: 
  country: United Kingdom
  citation: King D, Wittenberg R, Patel A, Quayyum Z, Berdunov V, Knapp M. The future incidence, prevalence and costs of stroke in the UK. Age Ageing. 2020 Feb 27;49(2):277-282. doi: 10.1093/ageing/afz163.
  PMID: 31957781
  citation: Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.
  PMID: 19608100
  citation: Gittins M, Vail A, Bowen A, Lugo-Palacios D, Paley L, Bray B, Gannon B, Tyson S. Factors influencing the amount of therapy received during inpatient stroke care: an analysis of data from the UK Sentinel Stroke National Audit Programme. Clin Rehabil. 2020 Jul;34(7):981-991. doi: 10.1177/0269215520927454. Epub 2020 Jun 7.
  PMID: 32508132
  citation: Kwakkel G, Kollen BJ. Predicting activities after stroke: what is clinically relevant? Int J Stroke. 2013 Jan;8(1):25-32. doi: 10.1111/j.1747-4949.2012.00967.x.
  PMID: 23280266
  citation: Warland A, Paraskevopoulos I, Tsekleves E, Ryan J, Nowicky A, Griscti J, Levings H, Kilbride C. The feasibility, acceptability and preliminary efficacy of a low-cost, virtual-reality based, upper-limb stroke rehabilitation device: a mixed methods study. Disabil Rehabil. 2019 Sep;41(18):2119-2134. doi: 10.1080/09638288.2018.1459881. Epub 2018 Apr 12.
  PMID: 29644897
  citation: Schroder J, van Criekinge T, Embrechts E, Celis X, Van Schuppen J, Truijen S, Saeys W. Combining the benefits of tele-rehabilitation and virtual reality-based balance training: a systematic review on feasibility and effectiveness. Disabil Rehabil Assist Technol. 2019 Jan;14(1):2-11. doi: 10.1080/17483107.2018.1503738. Epub 2018 Oct 14.
  PMID: 30318952
  citation: Kerr A, Smith M, Reid L, Baillie L. Adoption of Stroke Rehabilitation Technologies by the User Community: Qualitative Study. JMIR Rehabil Assist Technol. 2018 Aug 17;5(2):e15. doi: 10.2196/rehab.9219.
  PMID: 30120086
  citation: Kerr A, Keogh M, Slachetka M, Grealy M, Rowe P. An Intensive Exercise Program Using a Technology-Enriched Rehabilitation Gym for the Recovery of Function in People With Chronic Stroke: Usability Study. JMIR Rehabil Assist Technol. 2023 Jul 21;10:e46619. doi: 10.2196/46619.
  PMID: 37477954
  citation: National Clinical Guideline for Stroke for the UK and Ireland, 2023 edition. Royal College of Physicians, London UK.
  citation: Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
  PMID: 34593508
  responsible party type: Principal Investigator
  investigator affiliation: University of Strathclyde
  investigator full name: Gillian Sweeney
  investigator title: Principal Investigator
  mesh term: Stroke
  sharing ipd: No