Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT04697368
Eligibility Criteria:
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 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 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 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04697368
Study Brief:
Protocol Section:
NCT04697368