Enrolling by invitation NCT07284810
Tracking Self-Reported Functional Needs and Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cionic Neural Sleeve System.
- Who it may be relevant to
- Registry conditions: Upper Motor Neuron Disease. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Tracking Reported Activities and Needs for Self-care, Function, Outcomes, Relief, and Mood
Overview
The study aims to characterize the population of Cionic Neural Sleeve users and assess their health-related quality of life.
Interventions
- Device Cionic Neural Sleeve System
The sleeve assists participants during physical activity by delivering electrical stimulation that helps contract the necessary muscles at the correct time to improve movement.
Primary outcome measures
- Health Related Quality of Life [Time frame: Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- CIONIC — San Francisco
Identifiers
NCT: NCT07284810 · CIONIC-07-001