Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurolutions, Santa Cruz, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IpsiHand Therapy

Device

The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of hometherapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use.

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

Time frame: Change in AMAT score (points) from Baseline to 12 Weeks

The Arm Motor Ability Test (AMAT is used to measure functional limitation in the upper extremity in rehabilitative trials enrolling individuals with stroke primarily. The measure requires clients to perform 28 common unilateral and bilateral UE tasks. Performance on each task is timed by the evaluator and rated by the evaluator using a 6-point Functional Ability Scale from 0 to 5. A score of 0 indicates no attempt moving the affected upper extremity in the task. A score of 5 indicates one is using their affected arm with full movement, normal. One can achieve a total a range of 0 points to 140 points

Sponsors and collaborators

Lead sponsor

Neurolutions, Inc.

Industry

Registry information

Official study title

Ipsihand Device Use in Stroke Patients to Assess Motor Recovery of the Upper Extremity and Functional Outcomes

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Apr 8, 2020
Registry last updated: Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed