Evidence map›Paper›PMID 41815729›Full record

ArticleFrontiers in neurology

REhabilitation of Dysphagia with ACupuncture and auricular Therapy after severe acquired brain injury (REDACT study): a double-blind randomized controlled trial protocol.

Martina Calamini, Agnese De Nisco, Francesca Draghi, Francesca Cecchi, Paola Graziani, Antonello Grippo, Claudio Macchi, Daniela Maccanti, Annamaria Romoli, Silvia Pancani and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in neurology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06888219 (REhabilitation of Dysphagia with ACupuncture and AuriculoTherapy in Non-communicative Patients with Severe Acquired Brain Injury), which is not on this map. Not yet cited in PubMed.

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

NCT06888219 naenrolling by invitationnot on this map

REhabilitation of Dysphagia with ACupuncture and AuriculoTherapy in Non-communicative Patients with Severe Acquired Brain Injury (REDACT-Study): a Pilot Controlled Randomized Double Blinded Trial Study Protocol

TypeinterventionalSponsorFondazione Don Carlo Gnocchi ETSRan2024 to 2026Enrolled24ConditionsBrain Injury, Cognitive Impairment, Deglutition DisorderArmsAcupuncture and Auricolotherapy, Conventional logopedic rehabilitation
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Martina CalaminiSchool of Specialization in Physical and Rehabilitation Medicine, University of Florence, Florence, Italy.
Agnese De NiscoIRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
Francesca DraghiIRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
Francesca CecchiSchool of Specialization in Physical and Rehabilitation Medicine, University of Florence, Florence, Italy.
Paola GrazianiIRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
Antonello GrippoIRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
Claudio MacchiIRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
Daniela MaccantiIRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
Annamaria RomoliIRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
Silvia PancaniIRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
Carmelo GuidoRegional Reference Center for Traditional Chinese Medicine, Corporate Coordination Center for Complementary Medicine, AUSL Toscana Centro, Florence, Italy.
Bahia HakikiSchool of Specialization in Physical and Rehabilitation Medicine, University of Florence, Florence, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Neurogenic dysphagia affects up to 99% of patients with severe acquired brain injury (sABI) upon admission to intensive rehabilitation units (IRU) and increase clinical complications, resource use, and mortality. Conventional dysphagia rehabilitation often relies on active techniques, which are hardly applicable in non-collaborative patients, as is often the case with patients after sABI. In the absence of guidelines for dysphagia rehabilitation that consider the heterogeneity and clinical complexity of these patients, acupuncture and auriculotherapy (AA) could represent a valid intervention to be introduced into clinical practice. The aim of this multicenter double-blind, randomized, controlled trial is to evaluate the superiority of AA combined with conventional rehabilitation compared to conventional rehabilitation alone in improving dysphagia in non-cooperative vascular sABI patients. To this end, improvement in swallowing will be measured using both a clinical scale (Mann Assessment of Swallowing Ability-MASA) and a fiber optic endoscopic assessment (Pooling Score). Certain characteristics of patients admitted to IRUs after sABI, such as the rate and timing of decannulation, the infection rate, and the functional outcome measured by the Glasgow Outcome Scale-Extended, will also be taken into consideration as secondary outcomes. By incorporating AA therapy into a personalized rehabilitation program, this study will examine its potential clinical benefits on dysphagia and the feasibility of this approach in the setting of early intensive rehabilitation for patients with sABI. AA could represent a low-cost, accessible bedside treatment complementary to standard rehabilitation, with no adverse effects, applicable in different clinical settings and at all stages of rehabilitation. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT06888219, NCT06888219.

Indexed as

acupunctureauriculotherapydysphagia (swallowing disorder)rehabilitationsevere acquired brain injuriestracheal cannula

Identifiers

PMID41815729
PMCPMC12971464

What Socratic 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 Socratic graph.