Evidence map›Paper›PMID 41815092›Full record

Trial reportStroke2026

Exoskeleton-Assisted Therapy Enhances Upper Limb Motor Recovery in Early Subacute Stroke: A Multicenter, Single-Blind Randomized Controlled Trial.

Giovanni Morone, Sanaz Pournajaf, Marco Iosa, Michela Goffredo, Maria Rosaria Leo, Stefano Paolucci, Maria Teresa Gatta, Andrea Santamato, Sofia Straudi, Rocco Salvatore Calabrò and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Stroke, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04697368 (A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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.

NCT04697368 naactive not recruitingnot on this map

A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

TypeinterventionalSponsorIRCCS San Raffaele RomaRan2020 to 2025Enrolled70ConditionsStroke, Upper Extremity ParesisArmsExoskeleton-Assisted Upper Limb Rehabilitation, Traditional Upper Limb Rehabilitation
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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.

Giovanni Morone *Department of Life, Health and Environmental Sciences, University of L'Aquila, Italy (G.M.).
Sanaz Pournajaf *Department of Neuroscience, Research Area in Neuromotor Rehabilitation and Rehabilitation Robotics, IRCSS San Raffaele Roma, Rome, Italy (S. Pournajaf, M.G., M.F.).ORCID 0000-0001-8749-2236
Marco IosaDepartment of Psychology, Sapienza University of Rome, Italy (M.I.).ORCID 0000-0003-2434-3887
Michela GoffredoDepartment of Neuroscience, Research Area in Neuromotor Rehabilitation and Rehabilitation Robotics, IRCSS San Raffaele Roma, Rome, Italy (S. Pournajaf, M.G., M.F.).ORCID 0000-0002-2651-8479
Maria Rosaria LeoPresidio Ospedaliero Accreditato Villa Bellombra, Bologna, Italy (M.R.L.).
Stefano PaolucciSanta Lucia Foundation, Scientific Institute for Research, Hospitalization and Health Care (IRCCS), Rome, Italy (M.I., S. Paolucci).ORCID 0000-0002-3105-1148
Maria Teresa GattaFondazione Centri di Riabilitazione Padre Pio ONLUS, Presidio "Gli Angeli di Padre Pio", San Giovanni Rotondo (FG), Italy (M.T.G.).
Andrea SantamatoPhysical Medicine and Rehabilitative Unit-Riuniti Hospital, University of Foggia, Italy (A.S.).
Sofia StraudiDepartment of Neuroscience and Rehabilitation, University of Ferrara, Italy (S.S.).ORCID 0000-0002-2061-9922
Rocco Salvatore CalabròIRCCS Centro Neurolesi Bonino-Pulejo, Messina, Italy (R.S.C.).ORCID 0000-0002-8566-3166
Marco FranceschiniDepartment of Neuroscience, Research Area in Neuromotor Rehabilitation and Rehabilitation Robotics, IRCSS San Raffaele Roma, Rome, Italy (S. Pournajaf, M.G., M.F.).ORCID 0000-0002-2131-1583
Italian PowerUPS-Rehab Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRobot-assisted therapy (RAT) with exoskeletons is believed to enhance motor recovery in stroke survivors. RAT offers intensive, feedback-based, task-oriented training to improve function. This study evaluated exoskeleton-based RAT integrated into usual rehabilitation care for individuals in early subacute stroke.

methodsThis multicenter randomized controlled trial was conducted across 8 stroke neurorehabilitation units over a 3-year period (December 2020-March 2024). Inpatients with moderate-to-severe upper limb impairment postsubacute stroke (<3 months poststroke) were randomized (1:1) to 25 sessions (5/week for 5 weeks) of exoskeleton-assisted RAT (robotic group) or conventional rehabilitation (control group). Outcome assessors were blinded. The primary outcome was the change in the Fugl-Meyer Assessment for Upper Limb (motor section, 0-66) from baseline to treatment end. Secondary outcomes addressed body function, activity (capacity/performance), and participation. Clinical assessments were at baseline (T0), posttreatment (T1), and 6-month telephone follow-up (T2). Odds ratio for achieving a minimal clinically important difference (≥10 points) on the Fugl-Meyer Assessment for Upper Limb was calculated.

resultsA total of 109 individuals with subacute stroke were screened. Of these, 94 (35% women; mean age 62.5±13.5 years; mean onset 34±28 days) were eligible and randomized, and 82 completed the intervention (12% dropout). No significant differences were observed at baseline, despite the median Fugl-Meyer score being 16 in the robotic group and 10 in the control group. The robotic group showed significantly greater improvement in Fugl-Meyer Assessment for Upper Limb motor score than the control group, with a median between-group difference of 22 points (

conclusionsExoskeleton-assisted RAT offers significant clinical benefits in early poststroke upper limb recovery, yielding higher minimal clinically important difference rates on impairment outcomes but not on specific functional measures compared with conventional therapy. Further research should evaluate long-term effects and optimize protocols based on patient characteristics. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04697368.

Indexed as

Exoskeleton DeviceRecovery of FunctionStrokeStroke RehabilitationUpper ExtremityAgedFemaleHumansMaleMiddle AgedRoboticsSingle-Blind MethodTreatment Outcomeexoskeleton deviceminimal clinically important differenceroboticsstrokeupper extremity

Identifiers

PMID41815092
PMCPMC13117556

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.