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NuroSleeve Powered Brace & Stimulation System to Restore Arm Function

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ClinicalTrials.gov Identifier: NCT04798378
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : August 10, 2022
Information provided by (Responsible Party):
Mijail Demian Serruya, Thomas Jefferson University

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 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.

Condition or disease Intervention/treatment Phase
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 Device: Neurosleeve Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Myoelectric Devices for Restoration of Independent Arm Function in Children and Adults With Neurological Disease and Injury
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Treatment Arm
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).
Device: Neurosleeve
Myoelectric devices for restoration of independent arm function

Primary Outcome Measures :
  1. Change in Canadian Occupational Performance Measure score at 8 weeks [ Time Frame: 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.

Secondary Outcome Measures :
  1. Change from Baseline Action Research Arm Test (ARAT) score at 8 weeks [ Time Frame: 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.

Other Outcome Measures:
  1. Change from Baseline Motricity Index score at 8 weeks [ Time Frame: 8 weeks ]

    The Motricity Index measures strength in the arms and legs after stroke. The weighted score is based on the ordinal 6 point scale of Medical Research Council to measure maximal isometric muscle strength.

    From: Collin and Wade. Assessing motor impairment after stroke: A pilot reliability study. J. Neurol. Neurosurg. Psychiatry, 1990.

  2. Change in ABILHAND-Kids questionnaire score at 8 weeks (for participants aged < 18) [ Time Frame: 8 weeks ]
    The ABILHAND-Kids questionnaire was developed as a measure of manual ability and explores the most representative inventory of manual activities. The 21 items of ABILHAND-Kids defined a valid and reliable manual ability scale.

  3. Change in Box and Blocks score at 8 weeks [ Time Frame: 8 weeks ]
    The experimented counts how many uniformly sized cubes that can be moved from one half of an opened wooden box, over a partition to the other half of the opened box the participant can move in one minute, This measure reflects dexterity, grasp strength, ability to release, and speed of movement and will be performed while the participant is using the NuroSleeve. From Mathiowetz et al, 1985.

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04798378

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Contact: Erica Jones 215-503-4042 CenterNR@jefferson.edu

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United States, Delaware
Nemours Children's Hospital Recruiting
Wilmington, Delaware, United States, 19803
Contact: Erica Jones, BA    215-503-4042    CenterNR@jefferson.edu   
Contact: Mena Scavina, DO       Mena.Scavina@nemours.org   
Sub-Investigator: Mena Scavina, DO         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Erica Jones    215-503-4042    CenterNR@jefferson.edu   
Principal Investigator: Mijail Serruya, MD, PhD         
Sponsors and Collaborators
Thomas Jefferson University
Additional Information:
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Responsible Party: Mijail Demian Serruya, Assistant Professor, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04798378    
Other Study ID Numbers: Neurosleeve 20D.372
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mijail Demian Serruya, Thomas Jefferson University:
Arm weakness, paralysis
functional electrical stimulation
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Muscular Dystrophies
Spinal Cord Injuries
Cerebral Palsy
Muscular Atrophy
Muscular Atrophy, Spinal
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Pathological Conditions, Anatomical
Neurodegenerative Diseases
Neuromuscular Diseases