Evidence map›Paper›PMID 26076696›Full record

Trial reportJournal of neuroengineering and rehabilitation2015

The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study.

Magdo Bortole, Anusha Venkatakrishnan, Fangshi Zhu, Juan C Moreno, Gerard E Francisco, Jose L Pons, Jose L Contreras-Vidal

3 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neuroengineering and rehabilitation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 91 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 7 pooled it
31.4field-weighted citation impact, top 1% 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.

NCT02114450 narecruitingnot on this map

Human Machine Interface System With the H2 Lower Limb Exoskeleton for Rehabilitation

TypeinterventionalSponsorUniversity of HoustonRan2015 to 2029Enrolled60ConditionsStroke, HemiparesisArmsRobot-assisted training with the H2 lower limb powered exoskeleton, Supervised motor practice
NCT04228224 nacompletednot on this mapstarted 2019, after this paper: background citation

Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile

TypeinterventionalSponsorCorporación de Rehabilitación Club de Leones Cruz del SurRan2019 to 2020Enrolled50ConditionsStrokeArmsRobot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain), Conventional gait rehabilitation
NCT04778852 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Quantitative Assessment of Training Effects Using a Wearable Exoskeleton in Parkinson Disease Patients

TypeinterventionalSponsorUniversity of PadovaRan2020 to 2023Enrolled50ConditionsParkinson DiseaseArmsExperimental: EksoGT, Functional kinematic training
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 7 syntheses or guidelines pooled it, 345 citations in OpenAlex.

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  10. Exploiting telerobotics for sensorimotor rehabilitation: a locomotor embodiment.Journal of neuroengineering and rehabilitation · 2021
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  14. Effects of a powered ankle-foot orthosis on perturbed standing balance.Journal of neuroengineering and rehabilitation · 2018
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31 more citing papers are in PubMed but not listed here.

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

7 authors at 4 institutions in 2 countries.

Magdo BortoleNeural Rehabilitation Group, Cajal Institute, Spanish Research Council, Av. Doctor Arce 37, Madrid, 28002, Spain. m.bortole@csic.es.
Anusha VenkatakrishnanNoninvasive Brain-Machine Interface Systems Laboratory, Department of Electrical and Computer Engineering, University of Houston, Houston, 77204-4005, USA. avenkatakrishnan@uh.edu.
Fangshi ZhuNoninvasive Brain-Machine Interface Systems Laboratory, Department of Electrical and Computer Engineering, University of Houston, Houston, 77204-4005, USA. fzhu@uh.edu.
Juan C MorenoNeural Rehabilitation Group, Cajal Institute, Spanish Research Council, Av. Doctor Arce 37, Madrid, 28002, Spain. jc.moreno@csic.es.
Gerard E FranciscoTIRR Memorial Hermann and Department of PM&R, University of Texas Health Sciences Center, 1333 Moursund Street, Houston, 77030, USA. gerard.e.francisco@uth.tmc.edu.
Jose L PonsNeural Rehabilitation Group, Cajal Institute, Spanish Research Council, Av. Doctor Arce 37, Madrid, 28002, Spain. jose.pons@csic.es.
Jose L Contreras-VidalNoninvasive Brain-Machine Interface Systems Laboratory, Department of Electrical and Computer Engineering, University of Houston, Houston, 77204-4005, USA. jlcontr2@central.uh.edu.
Instituto Cajal · ESUniversity of Houston · USMemorial Hermann Institute for Rehabilitation and Research Foundation · USPalo Alto Research Center · US

Funding

Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
NCATS NIH HHS UL1 TR000371
6 · The paper itself

Abstract

backgroundStroke significantly affects thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in stroke survivors. Recent technological developments in powered robotics exoskeletons can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. Here, we present the development and evaluation of a novel lower limb robotic exoskeleton, namely H2 (Technaid S.L., Spain), for gait rehabilitation in stroke survivors.

methodsH2 has six actuated joints and is designed to allow intensive overground gait training. An assistive gait control algorithm was developed to create a force field along a desired trajectory, only applying torque when patients deviate from the prescribed movement pattern. The device was evaluated in 3 hemiparetic stroke patients across 4 weeks of training per individual (approximately 12 sessions). The study was approved by the Institutional Review Board at the University of Houston. The main objective of this initial pre-clinical study was to evaluate the safety and usability of the exoskeleton. A Likert scale was used to measure patient's perception about the easy of use of the device.

resultsThree stroke patients completed the study. The training was well tolerated and no adverse events occurred. Early findings demonstrate that H2 appears to be safe and easy to use in the participants of this study. The overground training environment employed as a means to enhance active patient engagement proved to be challenging and exciting for patients. These results are promising and encourage future rehabilitation training with a larger cohort of patients.

conclusionsThe developed exoskeleton enables longitudinal overground training of walking in hemiparetic patients after stroke. The system is robust and safe when applied to assist a stroke patient performing an overground walking task. Such device opens the opportunity to study means to optimize a rehabilitation treatment that can be customized for individuals.

trial registrationThis study was registered at ClinicalTrials.gov ( https://clinicaltrials.gov/show/NCT02114450 ).

Indexed as

Exoskeleton DeviceRoboticsAdultAlgorithmsBiomechanical PhenomenaGait Disorders, NeurologicHumansLower ExtremityMaleMiddle AgedParesisPatient SafetyPhysical Therapy ModalitiesPilot ProjectsProsthesis DesignStroke

Identifiers

PMID26076696
PMCPMC4469252
OpenAlexW1580648284

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.