Phase
Condition
Cerebral Ischemia
Stroke
Treatment
Exoskeleton-Assisted Upper Limb Rehabilitation
Traditional Upper Limb Rehabilitation
Clinical Study ID
Ages 18-85 All Genders
Study Summary
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
Study Description
Connect with a study center
HABILITA S.p.A
Bergamo, BG
ItalySite Not Available
Villa Bellombra
Bologna,
ItalyCompleted
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara,
ItalyCompleted
Azienda Ospedaliero Universitaria Ospedali Riuniti
Foggia,
ItalyCompleted
IRCCS Centro Neurolesi Bonino Pulejo
Messina,
ItalyCompleted
IRCCS San Raffaele Pisana
Roma, 00163
ItalyActive - Recruiting
IRCCS fondazione Santa Lucia
Rome,
ItalyCompleted
Fondazione "Gli Angeli di Padre Pio"
San Giovanni Rotondo,
ItalyCompleted

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