Evidence map›Paper›PMID 32375815›Full record

Trial reportJournal of neuroengineering and rehabilitation2020

A new lower limb portable exoskeleton for gait assistance in neurological patients: a proof of concept study.

G Puyuelo-Quintana, R Cano-de-la-Cuerda, A Plaza-Flores, E Garces-Castellote, D Sanz-Merodio, A Goñi-Arana, J Marín-Ojea, E García-Armada

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Journal of neuroengineering and rehabilitation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 5 pooled it
3.5field-weighted citation impact, top 7% of its field
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

17 citing papers in PubMed, 5 syntheses or guidelines pooled it, 56 citations in OpenAlex.

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  17. Combining neural stimulation and a powered exoskeletal knee to enhance walking after stroke.Journal of rehabilitation and assistive technologies engineering
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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

8 authors at 3 institutions in 1 country.

G Puyuelo-QuintanaEscuela Internacional de Doctorado, Rey Juan Carlos University, Madrid, Spain.
R Cano-de-la-CuerdaDepartment of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine, Faculty of Health Sciences, Rey Juan Carlos University, Avda. Atenas s/n, 28922, Madrid, Spain. roberto.cano@urjc.es.
A Plaza-FloresMarsiBionics S.L., Madrid, Spain.
E Garces-CastelloteMarsiBionics S.L., Madrid, Spain.
D Sanz-MerodioMarsiBionics S.L., Madrid, Spain.
A Goñi-AranaCentre of Automation and Robotics, CSIC-UPM, Madrid, Spain.
J Marín-OjeaAita-Menni Hospital, Bilbao, Spain.
E García-ArmadaMarsiBionics S.L., Madrid, Spain.
Centre for Automation and Robotics · ESUniversidad Rey Juan Carlos · ESUniversidad de Alcalá · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFew portable exoskeletons following the assist-as-needed concept have been developed for patients with neurological disorders. Thus, the main objectives of this proof-of-concept study were 1) to explore the safety and feasibility of an exoskeleton for gait rehabilitation in stroke and multiple sclerosis patients, 2) to test different algorithms for gait assistance and measure the resulting gait changes and 3) to evaluate the user's perception of the device.

methodsA cross-sectional study was conducted. Five patients were recruited (4 patients with stroke and 1 with multiple sclerosis). A robotic, one-degree-of-freedom, portable lower limb exoskeleton known as the Marsi Active Knee (MAK) was designed. Three control modes (the Zero Force Control mode, Mode 1 and Mode 3) were implemented. Spatiotemporal gait parameters were measured by the 10-m walking test (10MWT), the Gait Assessment and Intervention Tool (G.A.I.T.) and Tinetti Performance Oriented Mobility Assessment (gait subscale) before and after the trials. A modified QUEST 2.0 questionnaire was administered to determine each participant's opinion about the exoskeleton. The data acquired by the MAK sensors were normalized to a gait cycle, and adverse effects were recorded.

resultsThe MAK exoskeleton was used successfully without any adverse effects. Better outcomes were obtained in the 10MWT and G.A.I.T. when Mode 3 was applied compared with not wearing the device at all. In 2 participants, Mode 3 worsened the results. Additionally, Mode 3 seemed to improve the 10MWT and G.A.I.T. outcomes to a greater extent than Mode 1. The overall score for the user perception of the device was 2.8 ± 0.4 95% CI.

conclusionsThe MAK exoskeleton seems to afford positive preliminary results regarding safety, feasibility, and user acceptance. The efficacy of the MAK should be studied in future studies, and more advanced improvements in safety must be implemented.

Indexed as

AlgorithmsExoskeleton DeviceAdultCross-Sectional StudiesFemaleGait Disorders, NeurologicHumansMaleMiddle AgedMultiple SclerosisPhysical Therapy ModalitiesProof of Concept StudyRoboticsStroke RehabilitationExoskeletonsFeasibilityGaitMultiple sclerosisSafetyStroke

Identifiers

PMID32375815
PMCPMC7201760
OpenAlexW3020910643

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.