title: 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'.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ISRCTN1648908; Pre-results. Clinicaltrials.gov ID: NCT02324634.
authors.affiliation: Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
authors.forename: Joanna C
authors.initials: JC
authors.lastname: Fletcher-Smith
authors.affiliation: Faculty of Health Sciences, University of Southampton, Southampton, UK.
authors.forename: Dawn-Marie
authors.initials: DM
authors.lastname: Walker
authors.affiliation: Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
authors.forename: Nikola
authors.initials: N
authors.lastname: Sprigg
authors.affiliation: Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
authors.forename: Marilyn
authors.initials: M
authors.lastname: James
authors.affiliation: Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
authors.forename: Marion F
authors.initials: MF
authors.lastname: Walker
authors.affiliation: Sheffield, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Allatt
authors.affiliation: Research Design Service East Midlands, University of Nottingham, Nottingham, UK.
authors.forename: Rajnikant
authors.initials: R
authors.lastname: Mehta
authors.affiliation: School of Health and rehabilitation, Keele University, Keele, UK.
authors.forename: Anand D
authors.initials: AD
authors.lastname: Pandyan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001132:Arm; D002985:Clinical Protocols; D003286:Contracture / Q000209:etiology / Q000517:prevention & control*; D004599:Electric Stimulation Therapy / Q000379:methods*; D005240:Feasibility Studies; D006801:Humans; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000502:physiology; D059352:Musculoskeletal Pain / Q000209:etiology / Q000517:prevention & control*; D010291:Paresis / Q000150:complications*; D010349:Patient Compliance; D011788:Quality of Life; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome; D014953:Wrist; D055815:Young Adult
keywords: Occupational Therapy; PAIN MANAGEMENT; QUALITATIVE RESEARCH