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| ID | Type | Description | Link |
|---|---|---|---|
| Unique Device Identifiers | Other Identifier | GS1 |
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This study will evaluate a wearable device intended to support balance and gait in adults with peripheral neuropathy. Participants will use the device for a defined period, and outcomes related to safety, usability, and functional performance will be assessed.
This clinical investigation will assess a non-invasive wearable device designed to enhance gait and balance in individuals with peripheral neuropathy. The study will evaluate whether the device can improve balance and gait stability during daily activities, and will also examine safety, comfort, and overall user acceptability over the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Device | Experimental | Participants use the active wearable device during the study period. |
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| Sham Device | Sham Comparator | Participants use a sham version of the wearable device without active functionality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active wearable device | Device | A non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Functional Gait Assessment (FGA) Total Score | Change in Functional Gait Assessment (FGA) total score (0-30 points) from baseline to 2 months. Higher scores indicate better gait and balance performance. | 2 months |
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Inclusion Criteria:
Signed informed consent prior to any study procedure.
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39738088 | Background | Gozzi N, Chee L, Odermatt I, Kikkert S, Preatoni G, Valle G, Pfender N, Beuschlein F, Wenderoth N, Zipser C, Raspopovic S. Wearable non-invasive neuroprosthesis for targeted sensory restoration in neuropathy. Nat Commun. 2024 Dec 30;15(1):10840. doi: 10.1038/s41467-024-55152-7. |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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Randomized, sham-controlled, multicenter.
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Participants and outcomes assessors are masked to group allocation (active vs. sham).A subset of care providers responsible for device setup and allocation is unblinded due to practical requirements, while other care providers interacting with participants remain blinded whenever feasible. Investigators at the site have access to allocation information if needed for safety or clinical decision-making.
| Sham wearable device | Device | A sham version of the wearable device without active functionality. |
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