Tracking Self-Reported Functional Needs and Quality of Life

N/AEnrolling By InvitationNCT07284810

Cionic, Inc.1,000 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Upper Motor Neuron Disease

Interventions

Cionic Neural Sleeve SystemDEVICE

The sleeve assists participants during physical activity by delivering electrical stimulation that helps contract the necessary muscles at the correct time to improve movement.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

CIONIC

San Francisco, California, United States

Outcomes

Primary Outcomes

Health Related Quality of Life

Health related quality of life will be assessed by the EuroQol-5 Dimensions 5-Levels (EQ-5D-5L), a 6-item instrument to describe health in 5 dimensions. Each response of the EQ-5D-5L is assigned a numerical value from 1 to 5, with 1 being "no problems" and 5 being "extreme problems".

Time frame: Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12

Data from ClinicalTrials.gov

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