Brain Computer Interface, Hemiparesis After Stroke, Stroke
Conditions
Keywords
Neurolutions, IpsiHand, Stroke, Hemiparesis after stroke, BCI
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIpsiHand
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.
Sponsors
Neurolutions, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer - Upper Extremity (FM-UE) , Manual Long Form | 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. | Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Barthel Index | 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. | Assessment tool that measures a person's functional independence in activities of daily living and self-care. |
| Zarit Caregiver Burden Scale (ZBI) | 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. | Widely used questionnaire designed to assess the level of burden experienced by caregivers. |
| Patient Specific Functional Scale (PSFS) | 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. | 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. |
| Euro-QOL5D5L | 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-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 |
Contacts
Primary ContactLauren Souders, MOT, OTR/L, CBIS, CSRS
Backup ContactSeth Wilk, PhD
Outcome results
None listed