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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2028-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Hemiparesis After Stroke Brain Computer Interface

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult stroke patients with upper extremity hemiparesis.

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

IpsiHand

Intervention Type DEVICE

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.

Interventions

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IpsiHand

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.

Intervention Type DEVICE

Other Intervention Names

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IpsiHand Therapy BCI Therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No