StrokeNCT05981729
Technology Enriched Stroke Rehabilitation in Acute/Sub-acute Stroke
A study testing Technology enriched stroke rehabilitation in people with Stroke, run by University of Strathclyde at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Technology enriched stroke rehabilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of new stroke by NHS Lanarkshire physician
- More than 48 hours since stroke event
- Deemed medically fit for rehabilitation by medical staff
- Deemed to require rehabilitation
- Able to provide informed consent
Who cannot join
- Acutely medically unwell
- Active cardiac disease, such as unstable angina
- Active delirium/significant levels of confusion
- Seizure within past 7 days
- Individual currently being managed under the Adults with Incapacity Act
- Known pregnancy
- Unable to follow verbal, written or gestured basic instructions
- Excessive pain or tonal issues which are deemed to contraindicate inclusion by medical/therapy team
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Wishaw
Wishaw, Lanarkshire, ML2 0DP
Gillian Sweeney, PhD, 01698 754555, gillian.sweeney@lanarkshire.scot.nhs.uk
Andrew Kerr, PhD, 01415482855, a.kerr@strath.ac.uk
About this study
Official title: Feasibility of Inpatient Technology Enriched Stroke Rehabilitation During the Acute and Sub-acute Phase After Stroke
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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- Technology enriched stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology enriched stroke rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Technology enhanced stroke rehabilitation | Experimental | Supported use of stroke rehabilitation technology Receives: Other: Technology enriched stroke rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of time spent on activities within the 'technology enriched rehabilitation space'
Time in minutes will be measured in which participants spent on activities within the 'technology enriched rehabilitation space'
Measured: 1 year
Movement repetitions
Number of movement repetitions completed within 'technology enriched rehabilitation' sessions will be measured by use of wearable activity monitors (armbands)
Measured: 1 year
Rates of recruitment and attrition
Percentage of eligible individual consenting to participate and percentage of people dropping/opting out before discharge.
Measured: 1 year
Adherence to sessions
Number of sessions attended as a percentage of those available/targeted
Measured: 1 year
Secondary outcomes (1)
Intervention Acceptability
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study with convenience sample. All in patients with diagnosis of stroke and who fit criteria will be offered intervention.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Strathclyde
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lanarkshire
- Responsible party
- Principal investigator, Gillian Sweeney, University of Strathclyde
- Investigators
- Gillian Sweeney, PhD, Principal investigator, South Health & Social Care Partnership
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981729
- Sponsor's protocol ID
- IAA_UoS/KerrBME/2023
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31957781Langhorne 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.
PubMed 19608100Gittins 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.
PubMed 32508132Kwakkel 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.
PubMed 23280266Warland 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.
PubMed 29644897Schroder 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.
PubMed 30318952Kerr 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.
PubMed 30120086Kerr 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.
PubMed 37477954National Clinical Guideline for Stroke for the UK and Ireland, 2023 edition. Royal College of Physicians, London UK.
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.
PubMed 34593508
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Inpatient Technology Enriched Stroke Rehabilitation During the Acute and Sub-acute Phase After Stroke
- ClinicalTrials.gov ID
- NCT05981729
- Acronym / sponsor ID
- IAA_UoS/KerrBME/2023
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of StrathclydeUniversity, hospital or other
- Collaborators
- NHS Lanarkshire
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study with convenience sample. All in patients with diagnosis of stroke and who fit criteria will be offered intervention.
| Arm | Type | Receives |
|---|---|---|
| Technology enhanced stroke rehabilitation | Experimental | Other: Technology enriched stroke rehabilitationSupported use of stroke rehabilitation technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of new stroke by NHS Lanarkshire physician
- More than 48 hours since stroke event
- Deemed medically fit for rehabilitation by medical staff
- Deemed to require rehabilitation
- Able to provide informed consent
Key exclusion criteria (8 listed)
- Acutely medically unwell
- Active cardiac disease, such as unstable angina
- Active delirium/significant levels of confusion
- Seizure within past 7 days
- Individual currently being managed under the Adults with Incapacity Act
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology enriched stroke rehabilitationIn 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. | Other | Technology enhanced stroke rehabilitation |
Primary outcome
Duration of time spent on activities within the 'technology enriched rehabilitation space'
Time frame: 1 year
Time in minutes will be measured in which participants spent on activities within the 'technology enriched rehabilitation space'
Movement repetitions
Time frame: 1 year
Number of movement repetitions completed within 'technology enriched rehabilitation' sessions will be measured by use of wearable activity monitors (armbands)
Rates of recruitment and attrition
Time frame: 1 year
Percentage of eligible individual consenting to participate and percentage of people dropping/opting out before discharge.
Adherence to sessions
Time frame: 1 year
Number of sessions attended as a percentage of those available/targeted
1 secondary outcome
Intervention Acceptability
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 31957781King 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.
- Background: PubMed 19608100Langhorne 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.
- Background: PubMed 32508132Gittins 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.
- Background: PubMed 23280266Kwakkel 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.
- Background: PubMed 29644897Warland 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.
- Background: PubMed 30318952Schroder 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.
- Background: PubMed 30120086Kerr 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.
- Background: PubMed 37477954Kerr 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.
- BackgroundNational Clinical Guideline for Stroke for the UK and Ireland, 2023 edition. Royal College of Physicians, London UK.
- Background: PubMed 34593508Skivington 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gillian Sweeney, PhD principal investigator
South Health & Social Care Partnership
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology enriched stroke rehabilitation in people with Stroke, run by University of Strathclyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gillian Sweeney, PhD (01698754555, gillian.sweeney@lanarkshire.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of time spent on activities within the 'technology enriched rehabilitation space' (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05981729, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.