NuroSleeve Powered Brace & Stimulation System to Restore Arm Function

  • STATUS
    Recruiting
  • days left to enroll
    8
  • participants needed
    20
  • sponsor
    Thomas Jefferson University
Updated on 4 October 2022
weakness
spasticity
range of motion
neurological disorder
Accepts healthy volunteers

Summary

The purpose of this study is to investigate if a person with weakness or paralysis in one or both arms, can use the NuroSleeve combined powered arm brace (orthosis) and muscle stimulation system to help restore movement in one arm sufficient to perform daily activities. This study could lead to the development of a product that could allow people with arm weakness or arm paralysis to use the NuroSleeve and similar devices to improve arm health and independent function.

Description

People can develop arm weakness due to stroke and other neurological conditions. Portable powered braces and functional electrical stimulation can help restore functional arm movement in these individuals. Powered braces and muscle stimulation may be triggered by detecting movement or electrical activity of proximal muscles that the person still can control. The overall objective of this study is to establish that children and adults with chronic, stable neurological motor impairment can achieve voluntary control over the NuroSleeve upper extremity orthosis and functional electrical stimulation system, and that they can use this voluntary control to perform functionally beneficial tasks to enhance independence, mental and physical health. While myoelectric prostheses have been studied for decades in children with limb loss, it is necessary to gather pilot data on the use of orthoses with optional electrical stimulation in people with intact yet paralyzed limbs. These adults and children have persistent motor deficits even after intensive physical and occupational therapy. The NuroSleeve and similar devices could help all people who have arm weakness.

Details
Condition Neurologic Diseases, Hemiparesis, Quadriplegia, Muscular Dystrophies, Arthrogryposis, Spinal Cord Injuries, Charcot-Marie-Tooth, Stroke, Weakness of Extremities as Sequela of Stroke, Weakness Due to Upper Motor Neuron Dysfunction, Amyotrophic Lateral Sclerosis, Spinal Muscular Atrophy, Arm Paralysis, Cerebral Palsy
Treatment Neurosleeve
Clinical Study IdentifierNCT04798378
SponsorThomas Jefferson University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

• Must be 4 years or older
Must have weakness in one or both arms such that wrist flexion and wrist extension are 3/5 on the Manual Muscle Testing Scale
The etiology of weakness is due to a neurological disease or injury 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 the study, 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 least one 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 the affected lower limb(s) precluding the operation of a wearable, powered orthotic device on the arm
Sufficient sitting balance to sit in a chair
No condition (e.g., severe arthritis, central pain) that would interfere with movement of the legs, ability to understand verbal commands and cooperate with test procedures
No condition that would pose a risk to the application of electrical current to the body (e.g., skin conditions or skin breakdown)

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 and
Excessive pain in one or both of the arms (> 5 on a 10-point visual analog scale)
trial participation
Excessive spasticity at one or both arms, as defined as a score of > 2 on the Modified
Ashworth Spasticity Scale
Metal implants or exposed metal in the weak or paralyzed arm
Advice from any of the participant's health providers that upper extremity powered
orthotics or electrical stimulation were contra-indicated
Lack of access to internet or wireless coverage to enable telemedicine-guided sessions
Presence of an implanted medical device in the body (such as cardiac pacemaker
Any history of seizure or epilepsy
implanted defibrillator, metallic device)
Currently taking the medication bupropion
Any history of alcohol or other substance use
Any history of prior neurosurgical procedure (only an exclusion criterion for those
seeking to undergo optional transcranial magnetic stimulation)
Known or suspected skull defect (only an exclusion criterion for those seeking to
undergo optional transcranial magnetic stimulation)
Other conditions or circumstances that, in the opinion of the investigators, would
preclude safe and/or effective participation, including severe skin conditions, and/or
other sequelae that may be contraindicated for using a powered orthotic or using
electrical stimulation, as well as personal circumstances
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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