Table 1

All items from the WHO trial registration data set

Data category	Information
Primary registry and trial identifying number	ISRCTN Registration ISRCTN16489086
Date of registration in primary registry	15/01/2015
Secondary identifying numbers	ClinicalTrials.gov NCT02324634
Source(s) of monetary or material support	Monetary support: Department of Health funding from the NIHR RfPB programme (PB-PG-1013-32034) Material support: NeuroTrac Rehab devices used for the intervention were donated by Verity Medical Ltd
Primary sponsor	University of Nottingham
Secondary sponsor(s)	Nottingham University Hospitals NHS Trust
Contact for public queries	JCF-S (principal investigator) Joanna.fletcher-smith@nottingham.ac.uk
Contact for scientific queries	JCF-S (principal investigator) Joanna.fletcher-smith@nottingham.ac.uk
Public title	Early Electrical Stimulation to prevent Complications to the Arm Post-Stroke—a feasibility study (ESCAPS)
Scientific title	Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm—a feasibility study
Countries of recruitment	England, UK
Health condition(s) or problem(s) studied	Stroke: prevention of post-stroke complications (eg, pain and contractures) in the upper limb
Intervention(s)	ES applied to the wrist extensors and wrist flexors for 30 min, twice a day, 5 days a week, for 3 months The ES will be set to deliver a 450 μs pulse at a frequency of 40–60 Hz (as per patient convenience). The intensity of the current will be increased to produce an alternating contraction of the flexors and extensors using a flex-hold-extend-hold pattern. A single stimulation and hold cycle will last 20 s and this will be cyclically repeated for 30 min Control group will receive usual care only and will not receive any ES treatment
Key inclusion and exclusion criteria	Inclusion criteria: Confirmed clinical diagnosis of first disabling stroke event affecting the upper limb Aged >18 years Impaired arm movement and strength (NIHSS arm subscore >0) resulting in reduced function, caused specifically by the stroke Exclusion criteria: Previous history of stroke affecting their upper limb Peripheral nerve injury/existing orthopaedic condition affecting the upper limb; fixed contractures at the elbow, wrist or fingers; malignancy in the area of the ES electrode placement; or epilepsy Cardiac pacemaker or similar implanted device Pregnancy Undiagnosed pain or skin conditions (not related to the stroke)
Study type	Feasibility RCT (single centre) Interventional Allocation: randomised Masking: unblinded (for practical reasons during the feasibility trial but in any subsequent pilot and definitive trials the outcomes assessor will be blinded)
Date of first enrolment	June 2015
Target sample size	40
Recruitment status	Recruiting
Primary outcome(s)	Pertain to the feasibility aims of the study: Feasibility of the trial design (12 months)—recruitment rates: number/per cent of participants recruited within 72 h post-stroke; time post-stroke that participants received their first treatment; recruitment strategy: number/per cent of patients screened, number/per cent eligible and approached, number/per cent who consented, number/per cent excluded after screening; completion rates: number/per cent of participants who completed the intervention; number/per cent of participants who received ES twice a day, 5 days a week while in hospital, and number/per cent who continued with the treatment regime after discharge. Mean, minimum and maximum number of ES treatments that participants received during the 3-month intervention period; recruitment of patients lacking mental capacity to consent for themselves: consultee consent rates (number/per cent of patients unable to give informed consent, and number consented by a consultee, number of consultees who declined consent) Tolerability (12 months)—proportion of participants who withdraw or decline intervention; records of interventions declined and why Integrity of the study protocol (12 months)—measured by examining how many participants are able to complete the study, per cent of missing data, and per cent of people who completed each of the outcome measures at 3-month, 6-month and 12-month follow-up, calculation of the cost of running the study
Key secondary outcomes	NIHSS score (0, 3, 6, 12 months)—neurological outcome and degree of recovery Barthel ADL Index score and modified Rankin score (0, 3, 6, 12 months)—independence (functional ability) in basic daily activities SPIN (0, 3, 6, 12 months)—pain in the affected arm Muscle contractures (reduction in range of movement and spasticity; 0, 3, 6, 12 months)—muscle contractures will be monitored by measuring muscle activity during assessments using Biometrics equipment ARAT (0, 3, 6, 12 months)—arm function SS-QOL (0, 3, 6, 12 months)—stroke-related quality of life EQ-5D (0, 3, 6, 12 months)—health status Patient resource use (cost) questionnaire (0, 3, 6, 12 months)—a measure of resource use and health-related costs CSI (0, 3, 6, 12 months)—carer strain NEADL (0 months)—premorbid functional state MoCA (0 months)—cognitive status at baseline

ADL, activities of daily living; ARAT, Action Research Arm Test; CSI, Caregiver Strain Index; ES, electrical stimulation; EQ-5D, EuroQoL-5D; ISRCTN, International Standard Randomised Controlled Trial Number; MoCA, The Montreal Cognitive Assessment; NEADL, Nottingham Extended ADL; NHS, National Health Service; NIHR, National Institute for Health Research; NIHSS, National Institute for Health Stroke Scale; RCT, randomised controlled trial; RfPB, Research for Patient Benefit; SPIN, Scale of Pain Intensity; SS-QOL, Stroke Specific Quality of Life Scale.