Technology Enriched Stroke Rehabilitation in Acute/Sub-acute Stroke

NCT05981729 | Unknown DMC

• 1 other identifier: IAA_UoS/KerrBME/2023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• 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'

  1 year

• Movement repetitions

  Number of movement repetitions completed within 'technology enriched rehabilitation' sessions will be measured by use of wearable activity monitors (armbands)

  1 year

• Rates of recruitment and attrition

  Percentage of eligible individual consenting to participate and percentage of people dropping/opting out before discharge.

  1 year

• Adherence to sessions

  Number of sessions attended as a percentage of those available/targeted

  1 year

Secondary Outcomes (1)

• Intervention Acceptability

  1 year

Study Arms (1)

Technology enhanced stroke rehabilitation

EXPERIMENTAL

Supported use of stroke rehabilitation technology

Other: Technology enriched stroke rehabilitation

Interventions

Technology enriched stroke rehabilitation OTHER

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.

Technology enhanced stroke rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Strathclyde: lead
• NHS Lanarkshire: collaborator

Study Sites (1)

University Hospital Wishaw

Wishaw, Lanarkshire, ML2 0DP, United Kingdom

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• National Clinical Guideline for Stroke for the UK and Ireland, 2023 edition. Royal College of Physicians, London UK.

  BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gillian Sweeney, PhD

  South Health & Social Care Partnership

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gillian Sweeney, PhD

CONTACT

01698754555; gillian.sweeney@lanarkshire.scot.nhs.uk

Andrew Kerr, PhD

CONTACT

01415482855; a.kerr@strath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility study with convenience sample. All in patients with diagnosis of stroke and who fit criteria will be offered intervention.

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 8, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)