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

Status: Active_not_recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Healthy Volunteers: t
View:

• 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)

Locations
United States
Delaware
Nemours Children's Hospital
Wilmington
Pennsylvania
Thomas Jefferson University
Philadelphia
Time Frame
Start Date: 2020-04-16
Completion Date: 2026-12
Participants
Target number of participants: 20
Treatments
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).
Sponsors
Leads: Thomas Jefferson University

This content was sourced from clinicaltrials.gov

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