Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2020-10-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IpsiHand Device

All participants will receive treatment with the IpsiHand Device.

Group Type EXPERIMENTAL

IpsiHand Therapy

Intervention Type 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.

Interventions

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IpsiHand Therapy

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No