Ipsihand Device Use in Stroke Patients to Assess Motor Recovery of the Upper Extremity and Functional Outcomes
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Neurolutions, Inc.
- Enrollment
- 24
- Locations
- 3
- Primary Endpoint
- Fugl-Meyer Assessment - Upper Extremity
Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
IpsiHand Device
All participants will receive treatment with the IpsiHand Device.
Intervention: IpsiHand Therapy (Device)
Outcomes
Primary Outcomes
Fugl-Meyer Assessment - Upper Extremity
Time Frame: "Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score.
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity.
Secondary Outcomes
- Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks(Change in AMAT score (points) from Baseline to 12 Weeks)