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ESCAPS study protocol: a feasibility randomised controlled trial of ‘Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm’

Fletcher-Smith, Joanna C.; Walker, Dawn-Marie; Sprigg, Nikola; James, Marilyn; Walker, Marion F.; Allatt, Kate; Mehta, Rajnikant; Pandyan, Anand D.

Authors

Joanna C. Fletcher-Smith

Dawn-Marie Walker

NIKOLA SPRIGG nikola.sprigg@nottingham.ac.uk
Professor of Stroke Medicine

MARILYN JAMES MARILYN.JAMES@NOTTINGHAM.AC.UK
Professor of Health Economics

Marion F. Walker

Kate Allatt

Rajnikant Mehta

Anand D. Pandyan



Abstract

Introduction Approximately 70% of patients with stroke experience impaired arm function, which is persistent and disabling for an estimated 40%. Loss of function reduces independence in daily activities and impacts on quality of life. Muscles in those who do not recover functional movement in the stroke affected arm are at risk of atrophy and contractures, which can be established as early as 6?weeks following stroke. Pain is also common. This study aims to evaluate the feasibility of a randomised controlled trial to test the efficacy and cost-effectiveness of delivering early intensive electrical stimulation (ES) to prevent post-stroke complications in the paretic upper limb.

Methods and analysis This is a feasibility randomised controlled trial (n=40) with embedded qualitative studies (patient/carer interviews and therapist focus groups) and feasibility economic evaluation. Patients will be recruited from the Stroke Unit at the Nottingham University Hospitals National Health Service (NHS) Trust within 72?h after stroke. Participants will be randomised to receive usual care or usual care and early ES to the wrist flexors and extensors for 30?min twice a day, 5?days a week for 3?months. The initial treatment(s) will be delivered by an occupational therapist or physiotherapist who will then train the patient and/or their nominated carer to self-manage subsequent treatments.

Ethics and dissemination This study has been granted ethical approval by the National Research Ethics Service, East Midlands Nottingham1 Research Ethics Committee (ref: 15/EM/0006). To our knowledge, this is the first study of its kind of the early application (within 72?h post-stroke) of ES to both the wrist extensors and wrist flexors of stroke survivors with upper limb impairment. The results will inform the design of a definitive randomised controlled trial. Dissemination will include 2 peer-reviewed journal publications and presentations at national conferences.

Citation

Fletcher-Smith, J. C., Walker, D., Sprigg, N., James, M., Walker, M. F., Allatt, K., …Pandyan, A. D. (2016). ESCAPS study protocol: a feasibility randomised controlled trial of ‘Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm’. BMJ Open, 6(1), Article e010079. https://doi.org/10.1136/bmjopen-2015-010079

Journal Article Type Article
Acceptance Date Oct 14, 2015
Publication Date Jan 4, 2016
Deposit Date Oct 31, 2016
Publicly Available Date Oct 31, 2016
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 6
Issue 1
Article Number e010079
DOI https://doi.org/10.1136/bmjopen-2015-010079
Public URL https://nottingham-repository.worktribe.com/output/773759
Publisher URL http://bmjopen.bmj.com/content/6/1/e010079

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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