Tracking Self-Reported Functional Needs and Quality of Life

Cionic

Status: Invitation-only

Conditions: Upper Motor Neuron Disease

Treatments: Device: Cionic Neural Sleeve System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07284810

CIONIC-07-001

Details and patient eligibility

About

The study aims to characterize the population of Cionic Neural Sleeve users and assess their health-related quality of life.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Resident of the United States
• New customer awaiting the Cionic Neural Sleeve

Exclusion criteria

• Implanted demand-type cardiac pacemaker or defibrillator
• Malignant tumor or existing thrombosis in the impacted or more impacted leg
• Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Cionic Neural Sleeve NS-200

Experimental group

Description:

Participants will wear the device and receive stimulation assistance during the exercise and walking sessions.

Treatment:

Device: Cionic Neural Sleeve System