Evidence map›Paper›PMID 31771600›Full record

Trial reportJournal of neuroengineering and rehabilitation2019

The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study.

Lynsey D Duffell, Sue Paddison, Ahmad F Alahmary, Nick Donaldson, Jane Burridge

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neuroengineering and rehabilitation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03834324 (The Effects of FES Cycling Combined With Virtual Reality Racing on Lower Limb Voluntary Function After Incomplete SCI), which is not on this map. Cited by 16 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 5 pooled it
–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.

NCT03834324 nacompletednot on this map

The Effects of FES Cycling Combined With Virtual Reality Racing on Lower Limb Voluntary Function After Incomplete SCI: A Pilot Study.

TypeinterventionalSponsorUniversity of SouthamptonRan2013 to 2018Enrolled11ConditionsSpinal Cord InjuriesArmsFES
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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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

5 authors.

Lynsey D DuffellDepartment of Medical Physics & Biomedical Engineering, University College London, Malet Place Engineering Building, Gower Street, London, WC1E 6BT, UK. l.duffell@ucl.ac.uk.ORCID 0000-0002-8137-6071
Sue PaddisonLondon Spinal Cord Injury Centre, Royal National Orthopaedic Hospital, Stanmore, UK.
Ahmad F AlahmaryFaculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.
Nick DonaldsonDepartment of Medical Physics & Biomedical Engineering, University College London, Malet Place Engineering Building, Gower Street, London, WC1E 6BT, UK.
Jane BurridgeFaculty of Environmental and Life Sciences, University of Southampton, Southampton, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFunctional Electrical Stimulation (FES) cycling can benefit health and may lead to neuroplastic changes following incomplete spinal cord injury (SCI). Our theory is that greater neurological recovery occurs when electrical stimulation of peripheral nerves is combined with voluntary effort. In this pilot study, we investigated the effects of a one-month training programme using a novel device, the iCycle, in which voluntary effort is encouraged by virtual reality biofeedback during FES cycling.

methodsEleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) were recruited and completed 12-sessions of iCycle training. Function was assessed before and after training using the bilateral International Standards for Neurological Classification of SCI (ISNC-SCI) motor score, Oxford power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index for Spinal Cord Injury and 10 m-walk test. Power output (PO) was measured during all training sessions.

resultsTwo of the 6 participants with chronic injuries, and 4 of the 5 participants with sub-acute injuries, showed improvements in ISNC-SCI motor score > 8 points. Median (IQR) improvements were 3.5 (6.8) points for participants with a chronic SCI, and 8.0 (6.0) points for those with sub-acute SCI. Improvements were unrelated to other measured variables (age, time since injury, baseline ISNC-SCI motor score, baseline voluntary PO, time spent training and stimulation amplitude; p > 0.05 for all variables). Five out of 11 participants showed moderate improvements in voluntary cycling PO, which did not correlate with changes in ISNC-SCI motor score. Improvement in PO during cycling was positively correlated with baseline voluntary PO (R

conclusionsImproved ISNC-SCI motor scores in chronic participants may be attributable to the iCycle training. In sub-acute participants, early spontaneous recovery and changes due to iCycle training could not be distinguished. The iCycle is an innovative progression from existing FES cycling systems, and positive results should be verified in an adequately powered controlled trial.

trial registrationClinicalTrials.gov, NCT03834324. Registered 06 February 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03834324. Protocol V03, dated 06.08.2015.

Indexed as

Virtual RealityAdultAgedAged, 80 and overBiofeedback, PsychologyElectric Stimulation TherapyExercise TherapyFemaleHumansMaleMiddle AgedPilot ProjectsRecovery of FunctionSpinal Cord InjuriesYoung AdultBiofeedbackCyclingFunctional electrical stimulationISNC-SCI motor scoreSpinal cord injuryVirtual reality

Identifiers

PMID31771600
PMCPMC6880599

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Registered trials

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.