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NCT04697368Completed

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

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

Source: ClinicalTrials.gov · Last updated 15 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
94 (actual)
First submitted
30 Dec 2020
Start date
28 Dec 2020
Primary completion date
1 Mar 2025
Lead sponsor
IRCCS San Raffaele Roma
Diseases
Stroke
NCT number
NCT04697368

What you commit to

  • Study type: Interventional
  • Participants enrolled: 94
  • From 28 Dec 2020 to the primary completion date, 1 Mar 2025
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • unstable general clinical conditions;
  • severe visual impairment;
  • 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 seizure during rehabilitation with Armeo Power;
  • history of physical or neurological conditions that interfere with study procedures or assessment of motor function;

Other

  • 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 study period, 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;
  • interruption of treatment for 1 week, or 5 consecutive sessions;
  • participation in other innovative treatment protocols for the upper limb rehabilitation (e.g. robotics, virtual reality, AOT ... etc).

Who the study is looking for

  • 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 to severe (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 the distance from the acute event (OAI≤30; OAI\> 30);
  • Modified Ashworth Scale (MAS) of the main components (shoulder, elbow, and wrist) of the upper limb \<3;
  • sufficient cognitive and linguistic level to understand the instructions and provide consent;
  • signed informed consent.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Villa Bellombra
Coordinator of this site? Confirm its status
BolognaItalyUnknown status
Azienda Ospedaliero Universitaria di Ferrara
Coordinator of this site? Confirm its status
FerraraItalyUnknown status
Azienda Ospedaliero Universitaria Ospedali Riuniti
Coordinator of this site? Confirm its status
FoggiaItalyUnknown status
IRCCS Centro Neurolesi Bonino Pulejo
Coordinator of this site? Confirm its status
MessinaItalyUnknown status
IRCCS San Raffaele Pisana
Coordinator of this site? Confirm its status
RomaItalyUnknown status
IRCCS Fondazione Santa Lucia
Coordinator of this site? Confirm its status
RomeItalyUnknown status
Fondazione "Gli Angeli di Padre Pio"
Coordinator of this site? Confirm its status
San Giovanni RotondoItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.