Evidence map›Paper›PMID 38129910›Full record

ArticleTrials2023

Cortico-cortical stimulation and robot-assisted therapy (CCS and RAT) for upper limb recovery after stroke: study protocol for a randomised controlled trial.

Alex Martino Cinnera, Sonia Bonnì, Alessia D'Acunto, Michele Maiella, Matteo Ferraresi, Elias Paolo Casula, Valentina Pezzopane, Marco Tramontano, Marco Iosa, Stefano Paolucci and 3 more

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

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05478434 (Cortico-cortical Stimulation and Robot-assisted Therapy a New Approach of Upper Limb Functional Recovery After Stroke), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 19% 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.

NCT05478434 naunknown statusnot on this map

Cortico-cortical Stimulation and Robot-assisted Therapy a New Approach of Upper Limb Functional Recovery After Stroke

TypeinterventionalSponsorI.R.C.C.S. Fondazione Santa LuciaRan2022 to 2025Enrolled32ConditionsStroke, Stroke, IschemicArmsCortico-cortical stimulation plus robot-assisted therapy, Sham cortico-cortical stimulation plus robot-assisted therapy
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. 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

13 authors at 6 institutions in 1 country.

Alex Martino CinneraScientific Institute for Research, Hospitalization and Health Care IRCCS Santa Lucia Foundation, Rome, Italy. a.martino@hsantalucia.it.ORCID http://orcid.org/0000-0001-7267-3253
Sonia BonnìScientific Institute for Research, Hospitalization and Health Care IRCCS Santa Lucia Foundation, Rome, Italy.
Alessia D'AcuntoScientific Institute for Research, Hospitalization and Health Care IRCCS Santa Lucia Foundation, Rome, Italy.
Michele MaiellaScientific Institute for Research, Hospitalization and Health Care IRCCS Santa Lucia Foundation, Rome, Italy.
Matteo FerraresiScientific Institute for Research, Hospitalization and Health Care IRCCS Santa Lucia Foundation, Rome, Italy.
Elias Paolo CasulaScientific Institute for Research, Hospitalization and Health Care IRCCS Santa Lucia Foundation, Rome, Italy.
Valentina PezzopaneScientific Institute for Research, Hospitalization and Health Care IRCCS Santa Lucia Foundation, Rome, Italy.
Marco TramontanoDepartment of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater University of Bologna, Bologna, Italy.
Marco IosaScientific Institute for Research, Hospitalization and Health Care IRCCS Santa Lucia Foundation, Rome, Italy.
Stefano PaolucciScientific Institute for Research, Hospitalization and Health Care IRCCS Santa Lucia Foundation, Rome, Italy.
Giovanni MoroneDepartment of Life, Health and Environmental Sciences, University of L'Aquila, 67100, L'Aquila, Italy.
Giuseppe VannozziScientific Institute for Research, Hospitalization and Health Care IRCCS Santa Lucia Foundation, Rome, Italy.
Giacomo KochDepartment of Neuroscience and Rehabilitation, University of Ferrara, Ferrara, Italy.
Fondazione Santa Lucia · ITForo Italico University of Rome · ITAzienda USL di Bologna · ITUniversity of Ferrara · ITUniversity of L'Aquila · ITUniversity of Rome Tor Vergata · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSince birth, during the exploration of the environment to interact with objects, we exploit both the motor and sensory components of the upper limb (UL). This ability to integrate sensory and motor information is often compromised following a stroke. However, to date, rehabilitation protocols are focused primarily on recovery of motor function through physical therapies. Therefore, we have planned a clinical trial to investigate the effect on functionality of UL after a sensorimotor transcranial stimulation (real vs sham) in add-on to robot-assisted therapy in the stroke population.

methodsA randomised double-blind controlled trial design involving 32 patients with a single chronic stroke (onset > 180 days) was planned. Each patient will undergo 15 consecutive sessions (5 days for 3 weeks) of paired associative stimulation (PAS) coupled with UL robot-assisted therapy. PAS stimulation will be administered using a bifocal transcranial magnetic stimulator (TMS) on the posterior-parietal cortex and the primary motor area (real or sham) of the lesioned hemisphere. Clinical, kinematics and neurophysiological changes will be evaluated at the end of protocol and at 1-month follow-up and compared with baseline. The Fugl-Meyer assessment scale will be the primary outcome. Secondly, kinematic variables will be recorded during the box-and-block test and reaching tasks using video analysis and inertial sensors. Single pulse TMS and electroencephalography will be used to investigate the changes in local cortical reactivity and in the interconnected areas. DISCUSSION: The presented trial shall evaluate with a multimodal approach the effects of sensorimotor network stimulation applied before a robot-assisted therapy training on functional recovery of the upper extremity after stroke. The combination of neuromodulation and robot-assisted therapy can promote an increase of cortical plasticity of sensorimotor areas followed by a clinical benefit in the motor function of the upper limb.

trial registrationClinicalTrials.gov NCT05478434. Registered on 28 Jul 2022.

Indexed as

RoboticsStrokeStroke RehabilitationHumansRandomized Controlled Trials as TopicRecovery of FunctionTreatment OutcomeUpper ExtremityArmBrain stimulationClinical trialNeuroplasticityNeurorehabilitationPaired associative stimulationRecoveryTherapyTranscranial magnetic stimulation

Identifiers

PMID38129910
PMCPMC10740274
OpenAlexW4390060669

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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.