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The study aims to characterize the population of Cionic Neural Sleeve users and assess their health-related quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cionic Neural Sleeve NS-200 | Experimental | Participants will wear the device and receive stimulation assistance during the exercise and walking sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cionic Neural Sleeve System | Device | The sleeve assists participants during physical activity by delivering electrical stimulation that helps contract the necessary muscles at the correct time to improve movement. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12 |
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| Measure | Description | Time Frame |
|---|---|---|
| Wear time | Wear time measured by the usage log of the device, measured in hours. | Every month from enrollment to the end of study at 12 months |
| Device adherence | Wear time measured by the usage log of the device, measured in step count. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIONIC | San Francisco | California | 94111 | United States |
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| ID | Term |
|---|---|
| D016472 | Motor Neuron Disease |
| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Every month from enrollment to the end of study at 12 months |
| Spasticity | 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. | Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12 |
| Urinary Incontinence | The frequency of urinary leaking will be collected. The score ranges from 1 - 5, with a higher score reflecting more frequent urinary incontinence. | Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12 |
| Fatigue | The impact of fatigue will be collected. The score ranges from 1 - 5, with a higher score reflecting more severe fatigue. | Day 0, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12 |