NuroSleeve Powered Brace & Stimulation System to Restore Arm Function

Status Recruiting

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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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.