Neurologic DiseasesNCT04798378
NuroSleeve Powered Brace & Stimulation System to Restore Arm Function
A study testing Neurosleeve in people with Neurologic Diseases and Hemiparesis, run by Thomas Jefferson University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurologic Diseases, Hemiparesis, Quadriplegia
- What is being tested?
- Neurosleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Apr 2020to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Nemours Children's Hospital
Wilmington, Delaware, 19803
About this study
Official title: Myoelectric Devices for Restoration of Independent Arm Function in Children and Adults With Neurological Disease and Injury
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.
Read the 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 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.
- Conditions
- Neurologic Diseases, Hemiparesis, Quadriplegia, Muscular Dystrophies, Arthrogryposis, Spinal Cord Injuries
- Being tested
- Neurosleeve
- Keywords
- Arm weakness, paralysis, orthosis, functional electrical stimulation, brace
- Medical subject headings
- Nervous System Diseases, Paresis, Quadriplegia, Muscular Dystrophies, Arthrogryposis, Spinal Cord Injuries, Charcot-Marie-Tooth Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurosleeveDevice
Myoelectric devices for restoration of independent arm function
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will received a customized NuroSleeve and undergo 8 weeks of occupational therapy using the NuroSleeve (135 minutes per week for 8 weeks: this can be done as 45 minutes three times per week, 68 minute sessions twice per week, or one 135 minute once per week). Receives: Device: Neurosleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Canadian Occupational Performance Measure score at 8 weeks
The Canadian Occupational Performance Measure (COPM) is an individualized measure designed for use by occupational therapists to detect self-perceived change in occupational performance problems over time. From Law et al., 2000.
Measured: 8 weeks
Secondary outcomes (1)
Change from Baseline Action Research Arm Test (ARAT) score at 8 weeks
The Action Research Arm Test (ARAT) measures specific changes in the arm function in people who sustained cerebral damage resulting in arm weakness. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch and gross movements. Each sub scale has items ordered according to ascending difficulty: 0- can not perform any part of the test, 1- performs the test partialy, 2- completes the test, but takes abnormally long time, 3- performs the test normally. The sum of all subscales are added to compute the total score. The total score ranges between 0 to 57. The higher score is considered to be better outcome.
From: Yozbatiran et al. A standardized approach to performing the action research arm test. Neurorehabil. Neural Repair, 2008.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start16 Apr 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mijail Demian Serruya, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798378
- Sponsor's protocol ID
- Neurosleeve 20D.372
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Khantan M, Avery M, Aung PT, Zarin RM, Hammelef E, Shawki N, Serruya MD, Napoli A. The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment. J Neuroeng Rehabil. 2023 Aug 4;20(1):103. doi: 10.1186/s12984-023-01228-2.
PubMed 37542335