Status:
ACTIVE_NOT_RECRUITING
The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
Lead Sponsor:
IRCCS San Raffaele Roma
Collaborating Sponsors:
Università degli Studi di Ferrara
Fondazione Gli Angeli di Padre Pio
Conditions:
Stroke
Upper Extremity Paresis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 impairmen...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 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;
- 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;
- 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).
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04697368
Start Date
December 28 2020
End Date
December 24 2025
Last Update
December 18 2025
Active Locations (7)
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1
Villa Bellombra
Bologna, Italy
2
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy
3
Azienda Ospedaliero Universitaria Ospedali Riuniti
Foggia, Italy
4
IRCCS Centro Neurolesi Bonino Pulejo
Messina, Italy