Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes

Neurolutions

Status: Completed

Conditions: Stroke

Treatments: Device: IpsiHand Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04338971

Ipsihand Use in Chronic Stroke

Details and patient eligibility

About

This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis. The Neurolutions System is a brain-computer interface (BCI) comprised of a robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which are measured by EEG electrodes. The system also utilizes a tablet interface to provide therapy instructions to the patient.

Full description

Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System. Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.

Enrollment: 24 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 6-months or more post stroke
• Presentation of upper extremity hemiparesis or hemiplegia
• Participants must english speaking
• Demonstrate intact cognition to provide informed consent
• Botox injections are allowed, and must continue regimen at regular intervals throughout the study

Exclusion Criteria -

• Not active in another clinical study
• Not receiving formal therapy for the upper extremity
• No use of other modalities or technologies to the upper extremity
• Cognitive Impairment: Short Blessed Test Score 9 or above
• Significant Spasticity: Modified Ashworth Scale score 3 or more at the elbow
• Significant Hemispatial Neglect: Mesulam Cancellation Test 3 or more unilaterally
• Insufficient Strength: Motricity Index score for shoulder abduction 18 - Any contractors of the affected upper extremity that would not allow the IpsiHand robotic exoskeleton to be worn comfortably and/or safely for device use

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

IpsiHand Device

Experimental group

Description:

All participants will receive treatment with the IpsiHand Device.

Treatment:

Device: IpsiHand Therapy