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NuroSleeve Powered Brace & Stimulation System to Restore Arm Function

Stroke Clinical Trial

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

Clinical 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. 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

  • Amyotrophic Lateral Sclerosis
  • Arm Paralysis
  • Arthrogryposis
  • Asthenia
  • Cerebral Palsy
  • Charcot-Marie-Tooth
  • Charcot-Marie-Tooth Disease
  • Hemiparesis
  • Hereditary Sensory and Motor Neuropathy
  • Motor Neuron Disease
  • Muscular Atrophy
  • Muscular Atrophy, Spinal
  • Muscular Dystrophies
  • Nerve Compression Syndromes
  • Nervous System Diseases
  • Neurologic Diseases
  • Paralysis
  • Paresis
  • Quadriplegia
  • Spinal Cord Injuries
  • Spinal Muscular Atrophy
  • Stroke
  • Weakness Due to Upper Motor Neuron Dysfunction
  • Weakness of Extremities as Sequela of Stroke
Clinical Trial Details
NCT number NCT04798378
Study type Interventional
Source Thomas Jefferson University
Contact Erica Jones
Phone 215-503-4042
Email CenterNR@jefferson.edu
Status Recruiting
Phase N/A
Start date April 16, 2020
Completion date December 2025
View Details
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