Evidence map›Paper›PMID 40912703›Full record

ArticleBMJ open2025

Efficacy of peroneal nerve functional electrical stimulation (FES) for the reduction of bradykinesia in Parkinson's disease: an assessor-blinded randomised controlled trial (STEPS II)-study protocol.

Abbey Tufft, Helen Neilens, Jonathan Marsden, Siobhan Creanor, Ayesha Ali, Margaret Donovan-Hall, Paigan Aspinall, Amber Lord, Ben Jones, Paul Taylor

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

10 authors.

Abbey TufftPeninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, Plymouth, UK abbey.tufft@plymouth.ac.uk.ORCID http://orcid.org/0009-0008-8199-5447
Helen NeilensPeninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, Plymouth, UK.
Jonathan MarsdenFaculty of Health, School of Health Professions, University of Plymouth, Plymouth, UK.
Siobhan CreanorExeter Clinical Trials Unit, Faculty of Health and Life Sciences, Department of Health and Community Sciences, Exeter Medical School, University of Exeter, Exeter, UK.
Ayesha AliExeter Clinical Trials Unit, Faculty of Health and Life Sciences, Department of Health and Community Sciences, Exeter Medical School, University of Exeter, Exeter, UK.
Margaret Donovan-HallSchool of Health Sciences, University of Southampton, Southampton, UK.
Paigan AspinallPeninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, Plymouth, UK.
Amber LordPeninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, Plymouth, UK.
Ben JonesExeter Clinical Trials Unit, Faculty of Health and Life Sciences, Department of Health and Community Sciences, Exeter Medical School, University of Exeter, Exeter, UK.
Paul TaylorSalisbury NHS Foundation Trust, Salisbury, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDifficulty with walking can lead to reduced quality of life for people with Parkinson's disease (pwPD); improving walking is considered a treatment priority. Drug therapies can control PD symptoms; however, pwPD often still experience mobility problems.Functional electrical stimulation (FES) induces movement in weak muscles via external electrical stimulation. FES is used in stroke and multiple sclerosis patients to correct dropped foot by stimulating the common peroneal nerve and is associated with improved quality of life and mobility. The randomised feasibility study preceding this definitive study showed that daily FES can produce a clinically meaningful improvement in walking speed in pwPD; this was sustained 4 weeks after FES was withdrawn. STEPS II is the first definitive randomised controlled trial, with blinded outcome assessment, aiming to determine the efficacy of FES in pwPD. METHODS AND ANALYSIS: STEPS II is a two-group, parallel, assessor-blinded, superiority randomised controlled trial with an internal pilot, designed to compare FES plus usual care versus usual care alone. 234 participants will be randomised across eight UK sites. Telephone pre-screening and face-to-face screening will determine eligibility. The intervention group will attend four unblinded FES visits to receive the device and assess walking with and without FES. All participants have blinded assessments at baseline and weeks 2, 6, 18 and 22. The primary objective is to compare whole body bradykinesia at 18 weeks post-baseline via changes in 10m walking speed. Secondary objectives will assess the wider effects of FES on Parkinsonian gait and quality of life. An embedded qualitative component will explore wider experiences of FES. ETHICS AND DISSEMINATION: This study received ethical approval from the Yorkshire and The Humber-Sheffield Research Ethics Committee (reference 23/YH/0193). A Data Monitoring Committee and Trial Steering Committee will provide independent oversight. Dissemination will be via publications, conferences and social media. FES intervention and training materials will be made open access. TRIAL REGISTRATION NUMBER: ISRCTN13120555.

Indexed as

Electric Stimulation TherapyHypokinesiaParkinson DiseasePeroneal NerveEquivalence Trials as TopicFemaleHumansMaleQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodTreatment OutcomeElectric Stimulation TherapyGaitParkinson-s diseaseWearable Devices

Identifiers

PMID40912703
PMCPMC12414162

What OpenQuestion holds

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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.