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NCT04798378Active, not recruiting

NuroSleeve Powered Brace & Stimulation System to Restore Arm Function

Myoelectric Devices for Restoration of Independent Arm Function in Children and Adults With Neurological Disease and Injury

Source: ClinicalTrials.gov · Last updated 9 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
10 Mar 2021
Start date
16 Apr 2020
Primary completion date
31 Dec 2025
Lead sponsor
Thomas Jefferson University
NCT number
NCT04798378

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 16 Apr 2020 to the primary completion date, 31 Dec 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Metal implants or exposed metal in the weak or paralyzed arm
  • 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)

Other illness

  • Orthopedic conditions of either arm that would affect performance on study
  • Untreated psychiatric or neurologic disturbances that would affect motivation and trial participation
  • Presence of an implanted medical device in the body (such as cardiac pacemaker, implanted defibrillator, metallic device)
  • Any history of seizure or epilepsy (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

Other

  • 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
  • Lack of access to internet or wireless coverage to enable telemedicine-guided sessions
  • Known or suspected skull defect (only an exclusion criterion for those seeking to undergo optional transcranial magnetic stimulation)

Who the study is looking for

  • 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)

Age in the registry: 4 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Thomas Jefferson University
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Nemours Children's Hospital
Coordinator of this site? Confirm its status
WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.