Evidence map›Paper›PMID 37974284›Full record

Trial reportTrials2023

The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a statistical analysis plan for a randomized controlled trial.

Marta Cipriani, Floriana Pichiorri, Emma Colamarino, Jlenia Toppi, Federica Tamburella, Matteo Lorusso, Alessandra Bigioni, Giovanni Morone, Francesco Tomaiuolo, Filippo Santoro and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report 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 NCT04353297 (The PROMOTOER), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 24% 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.

NCT04353297 nacompletednot on this map

The PROMOTOER: a BCI -Based Intervention That Promotes Upper Limb Functional Motor Recovery. A Randomized Clinical Trial to Test Long-term Efficacy and to Identify Determinants of Response to Intervention in Subacute Stroke Patients

TypeinterventionalSponsorI.R.C.C.S. Fondazione Santa LuciaRan2021 to 2023Enrolled49ConditionsStroke, Motor DisordersArmsEEG-based BCI system for (hand) Motor Imagery training, Motor Imagery training
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
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

15 authors at 3 institutions in 1 country.

Marta CiprianiDepartment of Neuroscience, Istituto Superiore di Sanità, Rome, Italy.
Floriana PichiorriFondazione Santa Lucia, IRCCS, Rome, Italy.
Emma ColamarinoFondazione Santa Lucia, IRCCS, Rome, Italy.
Jlenia ToppiFondazione Santa Lucia, IRCCS, Rome, Italy.
Federica TamburellaFondazione Santa Lucia, IRCCS, Rome, Italy.
Matteo LorussoFondazione Santa Lucia, IRCCS, Rome, Italy.
Alessandra BigioniFondazione Santa Lucia, IRCCS, Rome, Italy.
Giovanni MoroneFondazione Santa Lucia, IRCCS, Rome, Italy.
Francesco TomaiuoloDepartment of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Filippo SantoroResearch Coordination and Support Service, Istituto Superiore di Sanità, Rome, Italy.
Daniele CordellaIT Service, Istituto Superiore di Sanità, Rome, Italy.
Marco MolinariFondazione Santa Lucia, IRCCS, Rome, Italy.
Febo CincottiFondazione Santa Lucia, IRCCS, Rome, Italy.
Donatella MattiaFondazione Santa Lucia, IRCCS, Rome, Italy.
Maria PuopoloDepartment of Neuroscience, Istituto Superiore di Sanità, Rome, Italy. maria.puopolo@iss.it.ORCID http://orcid.org/0000-0001-5410-2334
Fondazione Santa Lucia · ITIstituto Superiore di Sanità · ITUniversity of Messina · IT

Funding

Ministero della Salute RF-2018-12365210
6 · The paper itself

Abstract

backgroundElectroencephalography (EEG)-based brain-computer interfaces (BCIs) allow to modulate the sensorimotor rhythms and are emerging technologies for promoting post-stroke motor function recovery. The Promotoer study aims to assess the short and long-term efficacy of the Promotoer system, an EEG-based BCI assisting motor imagery (MI) practice, in enhancing post-stroke functional hand motor recovery. This paper details the statistical analysis plan of the Promotoer study.

methodsThe Promotoer study is a randomized, controlled, assessor-blinded, single-centre, superiority trial, with two parallel groups and a 1:1 allocation ratio. Subacute stroke patients are randomized to EEG-based BCI-assisted MI training or to MI training alone (i.e. no BCI). An internal pilot study for sample size re-assessment is planned. The primary outcome is the effectiveness of the Upper Extremity Fugl-Meyer Assessment (UE-FMA) score. Secondary outcomes include clinical, functional, and user experience scores assessed at the end of intervention and at follow-up. Neurophysiological assessments are also planned. Effectiveness formulas have been specified, and intention-to-treat and per-protocol populations have been defined. Statistical methods for comparisons of groups and for development of a predictive score of significant improvement are described. Explorative subgroup analyses and methodology to handle missing data are considered. DISCUSSION: The Promotoer study will provide robust evidence for the short/long-term efficacy of the Promotoer system in subacute stroke patients undergoing a rehabilitation program. Moreover, the development of a predictive score of response will allow transferring of the Promotoer system to optimal clinical practice. By carefully describing the statistical principles and procedures, the statistical analysis plan provides transparency in the analysis of data.

trial registrationClinicalTrials.gov NCT04353297 . Registered on April 15, 2020.

Indexed as

Brain-Computer InterfacesStrokeStroke RehabilitationHumansPilot ProjectsRecovery of FunctionUpper ExtremityEEG-based brain-computer interfaceHand functional motor recoveryNeurorehabilitationRandomized controlled trialStatistical analysis planStroke

Identifiers

PMID37974284
PMCPMC10655338
OpenAlexW4388725594

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.