Phase
Condition
Neurologic Disorders
Stroke
Amyotrophic Lateral Sclerosis (Als)
Treatment
Neurosleeve
Clinical Study ID
Ages > 4 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:• Must be 4 years or older
Must have weakness in one or both arms such that flexion or extension of the wrist,elbow or shoulder are 3/5 or less on the Manual Muscle Testing Scale
The etiology of weakness is due to a neurological disease or injury or orthopediccondition that occurred 6 or more months ago
Participant is willing to comply with trial instructions
Adult participant is able to provide informed consent prior to enrollment in thestudy, and for children, child is able to provide assent and designated caregiver (parent or guardian) is able to provide informed consent
The participant is fluent in English and, if the participant were a child, at leastone parent/guardian were fluent in English
Medically stable and living at home in the community.
No joint contracture, spasticity or other limitations to range of motion in theaffected lower limb(s) precluding the operation of a wearable, powered orthoticdevice on the arm
Sufficient sitting balance to sit in a chair
No condition (e.g., severe arthritis, central pain) that would interfere withmovement of the legs, ability to understand verbal commands and cooperate with testprocedures.
No condition that would pose a risk to the application of electrical current to thebody (e.g., skin conditions or skin breakdown)
Exclusion
Exclusion Criteria:• Visual impairment such that following visually-guided instructions would be challenging even with ordinary corrective lenses
Orthopedic conditions of either arm that would affect performance on study
Untreated psychiatric or neurologic disturbances that would affect motivation andtrial participation
Excessive pain in one or both of the arms (> 5 on a 10-point visual analog scale)
Excessive spasticity at one or both arms, as defined as a score of > 2 on theModified Ashworth Spasticity Scale
Advice from any of the participant's health providers that upper extremity poweredorthotics or electrical stimulation were contra-indicated
Presence of an implanted medical device in the body (such as cardiac pacemaker,implanted defibrillator, metallic device)
Metal implants or exposed metal in the weak or paralyzed arm
Lack of access to internet or wireless coverage to enable telemedicine-guidedsessions
Any history of seizure or epilepsy (only an exclusion criterion for those seeking toundergo optional transcranial magnetic stimulation)
Currently taking the medication bupropion (only an exclusion criterion for thoseseeking to undergo optional transcranial magnetic stimulation)
Any history of prior neurosurgical procedure (only an exclusion criterion for thoseseeking to undergo optional transcranial magnetic stimulation)
Known or suspected skull defect (only an exclusion criterion for those seeking toundergo optional transcranial magnetic stimulation)
Any history of alcohol or other substance use
Other conditions or circumstances that, in the opinion of the investigators, wouldpreclude safe and/or effective participation, including severe skin conditions,and/or other sequelae that may be contraindicated for using a powered orthotic orusing electrical stimulation, as well as personal circumstances
Study Design
Study Description
Connect with a study center
Nemours Children's Hospital
Wilmington, Delaware 19803
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available

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