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

Trial Information
Status: Recruiting
Location: See location...
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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
4
Healthy Volunteers:
Accepts Healthy Volunteers

• Must have weakness in one or both arms such that wrist flexion and wrist extension are 3/5 on the Manual Muscle Testing Scale

• The etiology of weakness is due to a neurological disease or injury 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)

Where is this trial taking place?
United States
Pennsylvania
Thomas Jefferson University
Recruiting
Philadelphia
Who do I contact about this trial?
Primary
Erica Jones
Erica.Jones@jefferson.edu
2159558922
When is this trial taking place?
Start Date: June 1, 2021
Estimated Completion Date: December 2022
How many participants will be in this trial?
Target number of participants: 20
What treatment is being studied in this trial?
Experimental: Treatment Arm
Participants will received a customized NuroSleeve and undergo 8 weeks of occupational therapy using the NuroSleeve (45 minutes three times per week).
Who are the authors of this trial?

This content was sourced from clinicaltrials.gov