Prospective Real-World Evidence Study of the IpsiHand® System in Adult Stroke Survivors

Prospective Real-World Evidence Study of the IpsiHand® System in Adult Stroke Survivors

This study focuses on monitoring real-world customers who have been prescribed the IpsiHand® as part of their rehabilitation post-stroke. This study aims to evaluate their progress over time, assessing motor recovery, functional independence in activities of daily living (ADLs), caregiver burden, and health economic outcomes.

IpsiHand® is an FDA-authorized, non-invasive, BCI-based device that is indicated for use in chronic stroke patients (≥ 6 months post stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity. Through utilization of EEG signals from the unaffected side of the brain, the device enables stroke survivors to control a robotic hand orthosis, facilitating functional reorganization of the brain and improved motor recovery.

Inclusion Criteria:

1. Adult age 18-85 years.
2. Diagnosis of stroke six or more months prior with upper extremity weakness.
3. Has received an IpsiHand® system as a commercial customer for stroke rehabilitation.

Exclusion Criteria:

1. Severe cognitive impairment that would impede utilization of IpsiHand®
2. Any contraindications to IpsiHand® device use
3. Inability to comprehend English