Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Arthrogryposis
  • Amyotrophic Lateral Sclerosis
  • Weakness of Extremities as Sequela of Stroke
  • Arm Paralysis
  • Cerebral Palsy
  • Stroke
  • Weakness Due to Upper Motor Neuron Dysfunction
  • Charcot-Marie-Tooth
  • Hemiparesis
  • Muscular Dystrophies
  • Neurologic Diseases
  • Quadriplegia
  • Spinal Cord Injuries
  • Spinal Muscular Atrophy
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 4 years and 125 years
Gender
Both males and females

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 act...

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 myoelectric elbow-wrist-hand orthosis, that incorporates optional functional electrical stimulation, 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.

Tracking Information

NCT #
NCT04798378
Collaborators
Not Provided
Investigators
Not Provided