NuroSleeve Powered Brace & Stimulation System to Restore Arm Function

April 11, 2023 updated by: Mijail Demian Serruya, Thomas Jefferson University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • Mijail Serruya, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2020

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neurosleeve 20D.372

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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