NCT04798378

NuroSleeve Powered Brace & Stimulation System to Restore Arm Function

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Neurologic Diseases
• Hemiparesis
• Quadriplegia
• Muscular Dystrophies
• Arthrogryposis
• Spinal Cord Injuries
• Charcot-Marie-Tooth
• Stroke
• Weakness of Extremities as Sequela of Stroke
• Weakness Due to Upper Motor Neuron Dysfunction
• Amyotrophic Lateral Sclerosis
• Spinal Muscular Atrophy
• Arm Paralysis
• Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	Neurosleeve	Myoelectric devices for restoration of independent arm function

Timeline

• Start date: 2020-04-16
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2021-03-15
• Last updated: 2025-04-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study