Upper Motor Neuron Disease
Conditions
Brief summary
The study aims to characterize the population of Cionic Neural Sleeve users and assess their health-related quality of life.
Interventions
DEVICECionic 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.
Sponsors
Cionic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life | Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Wear time | Every month from enrollment to the end of study at 12 months | Wear time measured by the usage log of the device, measured in hours. |
| Device adherence | Every month from enrollment to the end of study at 12 months | Wear time measured by the usage log of the device, measured in step count. |
| Spasticity | Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12 | The impact of spasticity on walking or movement will be collected. The score ranges from 0 - 5, with a higher score reflecting more severe spasticity. |
| Urinary Incontinence | Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12 | The frequency of urinary leaking will be collected. The score ranges from 1 - 5, with a higher score reflecting more frequent urinary incontinence. |
| Fatigue | Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12 | The impact of fatigue will be collected. The score ranges from 1 - 5, with a higher score reflecting more severe fatigue. |
Countries
United States
Outcome results
None listed