The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
Launched by IRCCS SAN RAFFAELE ROMA · Jan 4, 2021
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness of using a robotic device, known as an exoskeleton, to help patients regain arm function after experiencing a stroke. The focus is on individuals who are in the sub-acute phase of recovery, which means they are between 2 weeks and 3 months after their first stroke and have difficulty moving their arm. The trial aims to see if this robot-assisted rehabilitation is better than traditional methods for improving arm movement in stroke patients.
To be eligible for the trial, participants must be between 18 and 85 years old and should have experienced their first stroke that affects their arm. They should also have moderate to severe weakness in their arm and be able to understand instructions and give consent. Participants can expect to receive rehabilitation sessions that involve the robotic device, which may help them recover arm function more quickly. It’s important to note that individuals with certain medical conditions or recent treatments may not be eligible. Overall, this trial hopes to find new ways to support stroke recovery and improve quality of life for patients.
Gender
ALL
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).
About Irccs San Raffaele Roma
IRCCS San Raffaele Roma is a prestigious clinical research institute located in Rome, Italy, dedicated to advancing medical science through innovative research and high-quality patient care. As a leading sponsor of clinical trials, it focuses on a wide range of therapeutic areas, fostering collaboration between researchers, healthcare professionals, and industry partners. The institute is committed to translating scientific discoveries into effective treatments, prioritizing patient safety and ethical standards throughout the research process. With state-of-the-art facilities and a multidisciplinary team of experts, IRCCS San Raffaele Roma is at the forefront of clinical research, contributing significantly to the global advancement of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ferrara, , Italy
Roma, , Italy
Messina, , Italy
Bergamo, Bg, Italy
Bologna, , Italy
Foggia, , Italy
Rome, , Italy
San Giovanni Rotondo, , Italy
Patients applied
Trial Officials
Marco Franceschini, Prof.
Principal Investigator
IRCCS San Raffaele Pisana
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials