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

Neurolutions

Status: Not yet enrolling

Conditions: Stroke; Brain Computer Interface; Hemiparesis After Stroke

Treatments: Device: IpsiHand

Study type: Observational

Funder types: Industry

Identifiers

NCT07147881

RWE_002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Adult stroke patients with upper extremity hemiparesis.

Description:

Chronic Stroke Patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation with use of the IpsiHand® System.

Treatment:

Device: IpsiHand