Evidence map›Paper›PMID 34127032›Full record

ArticleTrials2021

An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial.

Elvira Maranesi, Roberta Bevilacqua, Mirko Di Rosa, Giuseppe Pelliccioni, Valentina Di Donna, Riccardo Luzi, Micaela Morettini, Agnese Sbrollini, Elisa Casoni, Nadia Rinaldi and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04087083 (Assistive Robotic in the Elderly), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 51% 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.

NCT04087083 naunknown statusnot on this map

Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation

TypeinterventionalSponsorIstituto Nazionale di Ricovero e Cura per AnzianiRan2021 to 2024Enrolled150ConditionsStroke, Aging Problems, Innovative Rehabilitation Treatment Based on RoboticsArmsTechnological intervention arm, Control arm
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  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

14 authors at 2 institutions in 1 country.

Elvira MaranesiClinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy. e.maranesi@inrca.it.ORCID http://orcid.org/0000-0002-2414-3773
Roberta BevilacquaScientific Direction, IRCCS INRCA, Ancona, Italy.
Mirko Di RosaUnit of Geriatric Pharmacoepidemiology, IRCCS INRCA, Ancona, Italy.
Giuseppe PelliccioniNeurology Unit, IRCCS INRCA, Ancona, Italy.
Valentina Di DonnaClinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.
Riccardo LuziMedical Direction, IRCCS INRCA, Ancona, Italy.
Micaela MorettiniCardiovascular Bioengineering Lab, Department of Information Engineering, Università Politecnica delle Marche, Ancona, Italy.
Agnese SbrolliniCardiovascular Bioengineering Lab, Department of Information Engineering, Università Politecnica delle Marche, Ancona, Italy.
Elisa CasoniClinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.
Nadia RinaldiClinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.
Renato BaldoniClinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.
Fabrizia LattanzioScientific Direction, IRCCS INRCA, Ancona, Italy.
Laura BurattiniCardiovascular Bioengineering Lab, Department of Information Engineering, Università Politecnica delle Marche, Ancona, Italy.
Giovanni R RiccardiClinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.
Istituti di Ricovero e Cura a Carattere Scientifico · ITMarche Polytechnic University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke, and improving walking function is often a key component of any rehabilitation program. To achieve this goal, a robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects.

methodsIn this single-blind randomized controlled trial, we will include 152 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. Twenty treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 min. The technological intervention group, using the G-EO system, will carry out 30 min of traditional therapy and 20 min of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, and acceptance of the technology, will be carried. DISCUSSION: The final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation, focused on the use of a robotic device, in order to obtain the beneficial effects of this treatment.

trial registrationClinicalTrials.gov NCT04087083 . Registered on September 12, 2019.

Indexed as

StrokeStroke RehabilitationAccidental FallsAgedExercise TherapyFearGaitHumansMiddle AgedRandomized Controlled Trials as TopicSingle-Blind MethodTreatment OutcomeEnd-effector gait rehabilitationGait trainingStroke patients

Identifiers

PMID34127032
PMCPMC8204575
OpenAlexW3172098389

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.