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

Launched by IRCCS SAN RAFFAELE ROMA · Jan 4, 2021

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).