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.
Study Type
OBSERVATIONAL
Enrollment
100
IpsiHand is a therapeutic device that uses a brain-computer interface system which detects neural signals associated with motor intent and translates them into assisted hand movements in individuals with upper extremity impairment following a stroke.
Fugl-Meyer - Upper Extremity (FM-UE) , Manual Long Form
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Time frame: Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.
The Barthel Index
Assessment tool that measures a person's functional independence in activities of daily living and self-care.
Time frame: Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.
Zarit Caregiver Burden Scale (ZBI)
Widely used questionnaire designed to assess the level of burden experienced by caregivers.
Time frame: Baseline Visit, 12-Week, 24-Week, 36 Week, 12-Months, and 24-Months post-use of IpsiHand Device or at time of completion of IpsiHand device use if occurring prior to 24-Months.
Patient Specific Functional Scale (PSFS)
patient-reported outcome measure used to assess an individual's ability to perform specific functional activities that are important to them. It is commonly used in rehabilitation and clinical settings to track progress over time in response to treatment.
Time frame: Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.
Euro-QOL5D5L
Patient-reported outcome measure used to assess health-related quality of life (HRQoL) across different diseases and treatments. It is widely used in clinical research, health economics, and healthcare decision-making to quantify the impact of health conditions and interventions on daily living
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Time frame: Baseline Visit, 12-Week, 24-Week, 36 Week, 12-Months, and 24-Months post-use of IpsiHand Device or at time of completion of IpsiHand device use if occurring prior to 24-Months.