The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

Last updated: July 11, 2025
Sponsor: IRCCS San Raffaele Roma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Treatment

Exoskeleton-Assisted Upper Limb Rehabilitation

Traditional Upper Limb Rehabilitation

Clinical Study ID

NCT04697368
RP 20/08
  • Ages 18-85
  • All Genders

Study Summary

Loss of arm function is a common and distressing consequence of stroke. Neurotechnology-aided rehabilitation could be a promising approach to accelerate the recovery of upper limb functional impairments. This multicentre randomized controlled trial is aimed at assessing the efficacy of robot-assisted upper limb rehabilitation in subjects with sub-acute stroke following a stroke, compared to the traditional upper limb rehabilitation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age between 18 and 85 years;

  • first stroke with neurological outcomes affecting the upper limb;

  • patients with severe or moderate hemiparesis (FM-UL≤44), stratified according tosevere (FM-UL ≤ 22) or moderate (22 <FM-UL ≤ 44) motor deficit;

  • patients in the sub-acute phase within 90 days of the acute event, stratified by thedistance from the acute event (OAI≤30; OAI> 30);

  • Modified Ashworth Scale (MAS) of the main components (shoulder, elbow, and wrist) ofthe upper limb <3;

  • sufficient cognitive and linguistic level to understand the instructions and provideconsent;

  • signed informed consent.

Exclusion

Exclusion Criteria:

  • unstable general clinical conditions;

  • severe visual impairment;

  • inability to maintain the sitting position;

  • mild motor deficit of the arm (FM-UL> 44) at baseline;

  • recent botox injection in the upper limb or planned botox injection during the studyperiod, including the follow-up;

  • inability to don the orthosis on the impaired upper limb;

  • bone instability in relevant areas of the upper extremity (unconsolidated fractures,fractures due to osteoporosis);

  • fixed contractures involving the impaired upper limb (e.g. frozen shoulder);

  • shoulder instability;

  • severe pain syndromes caused or intensified by rehabilitation with Armeo Power;

  • patients who need isolation for infectious diseases ;

  • epileptic disorder with frequent attacks that carry the risk of having a seizureduring rehabilitation with Armeo Power;

  • history of physical or neurological conditions that interfere with study proceduresor assessment of motor function;

  • interruption of treatment for 1 week, or 5 consecutive sessions;

  • participation in other innovative treatment protocols for the upper limbrehabilitation (e.g. robotics, virtual reality, AOT ... etc).

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Exoskeleton-Assisted Upper Limb Rehabilitation
Phase:
Study Start date:
December 28, 2020
Estimated Completion Date:
December 24, 2025

Study Description

Stroke is the most common cause of complex adult disability in high-income countries [1]. Loss of arm function affects 69% of people who have a stroke [2]. Only 12% of people with arm weakness at the onset of stroke make a full recovery [3]. Improving arm function has been identified as a research priority by stroke survivors, carers, and health professionals who report that current rehabilitation pays insufficient attention to arm recovery [4].

Robot-assisted training enables a greater number of repetitive tasks to be practiced in a consistent and controllable manner. Repetitive task training is known to drive Hebbian plasticity, where the wiring of pathways that are coincidently active is strengthened [5, 6]. A dose of greater than 20 h of repetitive task training improves upper limb motor recovery following a stroke [7] and, therefore, robot-assisted training has the potential to improve arm motor recovery after stroke. We anticipate that Hebbian neuroplasticity, which is learning dependent, will operate regardless of the post-stroke phase. We, hereby, describe the protocol for a multicentre randomized controlled trial to determine whether robot-assisted training improves upper limb function following a stroke in the sub-acute stage.

Connect with a study center

  • HABILITA S.p.A

    Bergamo, BG
    Italy

    Site Not Available

  • Villa Bellombra

    Bologna,
    Italy

    Completed

  • Azienda Ospedaliero-Universitaria di Ferrara

    Ferrara,
    Italy

    Completed

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Foggia,
    Italy

    Completed

  • IRCCS Centro Neurolesi Bonino Pulejo

    Messina,
    Italy

    Completed

  • IRCCS San Raffaele Pisana

    Roma, 00163
    Italy

    Active - Recruiting

  • IRCCS fondazione Santa Lucia

    Rome,
    Italy

    Completed

  • Fondazione "Gli Angeli di Padre Pio"

    San Giovanni Rotondo,
    Italy

    Completed

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