Evidence map›Paper›PMID 39522015›Full record

ArticleBMC neurology2024

Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial.

Ali Ali, Avril D McCarthy, Mark Reeves, Jamie Healey, Louise Moody, Adewale Adebajo, Tim Good, Simon Dixon, Kathleen Baster, Wendy Tindale and 1 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Ali AliSheffield Institute of Translational Neurosciences, University of Sheffield, Sheffield, UK. ali.ali@sheffield.ac.uk.
Avril D McCarthyClinical Engineering, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Mark ReevesClinical Engineering, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Jamie HealeyClinical Engineering, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Louise MoodyUniversity of Coventry, Coventry, UK.
Adewale AdebajoDepartment of Rheumatology, Barnsley Hospital NHS Foundation Trust, Barnsley, Barnsley, UK.
Tim GoodSchool of Health and Related Research (ScHARR), Faculty of Medicine, Dentistry and Health, The University of Sheffield, Sheffield, UK.
Simon DixonSchool of Health and Related Research (ScHARR), Faculty of Medicine, Dentistry and Health, The University of Sheffield, Sheffield, UK.
Kathleen BasterSchool of Health and Related Research (ScHARR), Faculty of Medicine, Dentistry and Health, The University of Sheffield, Sheffield, UK.
Wendy TindaleClinical Engineering, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Krishnan Padmakumari Sivaraman NairDepartment of Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.

Funding

National Institute for Health and Care Research Invention for Innovation (i4i) 201642
6 · The paper itself

Abstract

introductionPost stroke elbow spasticity (PSES) affects over a third of individuals following stroke and negatively impacts on functional recovery, comfort and quality of life. Drug therapies have limited efficacy and unwanted side effects, botulinum toxin, although effective, is costly, and conventional electrical stimulation therapies are limited long term by habituation. We aim to investigate the efficacy of Sheffield Adaptive Patterned Electrical Stimulation (SHAPES), that delivers temporally and spatially varying pattern of electrical stimulation, against transcutaneous electrical stimulation (TENS) and standard care at reducing PSES. METHODS AND

designOverall, 297 people with PSES will be randomised (1:1:1) to one of 3 arms: Standard care (no electrical stimulation), TENS (conventional patterned electrical stimulation) or SHAPES (adaptive patterned electrical stimulation). Both SHAPES and TENS are delivered using a specially designed electrical stimulation sleeve used for 60 min each day for 6-weeks. Outcome measures are completed at baseline, end of treatment (EOT 6 weeks) and then 6-weeks, 12-weeks and 24-weeks after the end of treatment. Efficacy will be determined based on the proportion of participants experiencing meaningful improvement (18%) in the 7-day Numerical Rating Scale (NRS-S) for PSES, compared between both intervention arms and standard care, and between the two intervention groups. Measures of arm motor function (Action Research Arm Test, MRC scale), and quality of life (SQoL-6D, EQ-5D) will also be measured along with a parallel health economic evaluation. DISCUSSION: The results of the SHAPES trial will inform management of elbow spasticity after stroke. The SHAPES intervention is a low cost, self-administered intervention for the management of spasticity that can be used repeatedly, and if found to be more effective than TENS or control has the potential to be widely implemented in the UK NHS healthcare setting. Furthermore, despite the wide use of TENS in the management of spasticity, this study will provide critically required evidence regarding its efficacy. The trial has been registered with the ISRCTN registry (ISRCTN26060261).

Indexed as

Muscle SpasticityStrokeArmElectric Stimulation TherapyFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicTranscutaneous Electric Nerve StimulationTreatment OutcomeElectrical stimulationRCTSHAPESSpasticityStrokeTENS

Identifiers

PMID39522015
PMCPMC11549865

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.