Status:
ACTIVE_NOT_RECRUITING
NuroSleeve Powered Brace & Stimulation System to Restore Arm Function
Lead Sponsor:
Thomas Jefferson University
Conditions:
Neurologic Diseases
Hemiparesis
Eligibility:
All Genders
4+ years
Phase:
NA
Brief 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 he...
Detailed 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 individ...
Eligibility Criteria
Inclusion
- • 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 orthopedic condition 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
- • 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 trial 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 the Modified Ashworth Spasticity Scale
- Advice from any of the participant's health providers that upper extremity powered orthotics 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-guided sessions
- Any history of seizure or epilepsy (only an exclusion criterion for those seeking to undergo optional transcranial magnetic stimulation)
- Currently taking the medication bupropion (only an exclusion criterion for those seeking to undergo optional transcranial magnetic stimulation)
- 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)
- Any history of alcohol or other substance use
- 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
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04798378
Start Date
April 16 2020
End Date
December 1 2026
Last Update
April 9 2025
Active Locations (2)
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1
Nemours Children's Hospital
Wilmington, Delaware, United States, 19803
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107