PULSE-I - Is rePetitive Upper Limb SEnsory stimulation early after stroke feasible and acceptable? A stratified single-blinded randomised controlled feasibility study

Kausik Chatterjee,Caroline Watkins,Sioned Davies,Rachel C Stockley,Mary Fisher Morris,Turo Nurmikko,Brenda Ankers,Katy Cottrell,Steven Lane,Nick Fallon

doi:10.1186/s13063-019-3428-y

Abstract

BackgroundReduction in sensorimotor function of the upper limb is a common and persistent impairment after stroke, and less than half of stroke survivors recover even basic function of the upper limb after a year. Previous work in stroke has shown that repetitive sensory stimulation (RSS) of the upper limb may benefit motor function. As yet, there have been no investigations of RSS in the early-acute period despite this being the time window during which the neuroplastic processes underpinning sensorimotor recovery are likely to occur.MethodsA single-blinded, stratified, randomised controlled feasibility study was undertaken at two NHS acute trusts to determine the recruitment rate, intervention adherence, and safety and acceptability of an RSS intervention in the early period after stroke. Participants were recruited within 2 weeks of index stroke. Stratified on arm function, they were randomised to receive either 45 min of daily RSS and usual care or usual care alone (UC) for 2 weeks. Changes from baseline on the primary outcome of the Action Research Arm Test (ARAT) to measurements taken by a blinded assessor were examined after completion of the intervention (2 weeks) and at 3 months from randomisation.ResultsForty patients were recruited and randomised (RSS n = 23; UC n = 17) with a recruitment rate of 9.5% (40/417) of patients admitted with a stroke of which 52 (12.5%) were potentially eligible, with 10 declining to participate for various reasons. Participants found the RSS intervention acceptable and adherence was good. The intervention was safe and there were no serious adverse events.ConclusionsThis study indicates that recruitment to a trial of RSS in the acute period after stroke is feasible. The intervention was well tolerated and appeared to provide additional benefit to usual care. In addition to a definitive trial of efficacy, further work is warranted to examine the effects of varying doses of RSS upon arm function and the mechanism by which RSS induces sensorimotor recovery in the acute period after stroke.Trial registrationISRCTN, registry no: ISRCTN17422343; IRAS Project ID: 215137. Registered on October 2016

Highlights

Reduction in sensorimotor function of the upper limb is a common and persistent impairment after stroke, and less than half of stroke survivors recover even basic function of the upper limb after a year
Further research is needed to inform an ‘optimum’ dose of repetitive sensory stimulation (RSS) to benefit motor function after stroke as inconsistencies in the data mean that there is little evidence on which to base current treatment parameters. The results from this single-blinded, randomised controlled feasibility study show that RSS is acceptable to use in the early acute period after stroke and that recruitment to a trial to determine its effectiveness is feasible but is likely to require a multi-centre design
This is the first study of RSS in the acute period after stroke and showed that an RSS intervention was well tolerated and that participants were largely adherent to the daily RSS programme over 2 weeks

Summary

Introduction

Reduction in sensorimotor function of the upper limb is a common and persistent impairment after stroke, and less than half of stroke survivors recover even basic function of the upper limb after a year. There have been no investigations of RSS in the early-acute period despite this being the time window during which the neuroplastic processes underpinning sensorimotor recovery are likely to occur. Recent work has identified a 5-week critical window after stroke in which most of the neuroplasticity that underpins recovery of sensorimotor control of the upper limb occurs [10]. This period presents a short but sensitive phase of increased responsiveness to rehabilitation after stroke. Difficulties arise as it requires participants to be consistently and highly motivated, and rehabilitation staff need to have the time and resources to support RTT [11, 12]

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