Table 6 Incidence of causally-related adverse events during the trial period of the present study
Adverse event | Main cause | Incidence % | Events |
|---|---|---|---|
Overall patient number = 14 of 30 | 46.7% (total patients) | 19 (total events) | |
Myalgia | Walk program, weight of the device itself | 13.3% | 4 |
Contact dermatitis | Contact with the electrodes | 10.0% | 3 |
Back pain | Walk program, contact with the back module | 6.7% | 2 |
Excoriation | Contact with the cuffs | 6.7% | 2 |
Erythema | Contact with the electrodes | 3.3% | 1 |
Skin exfoliation | Contact with the electrodes | 3.3% | 1 |
Arthralgia | Walk program | 3.3% | 1 |
Arthrosis deformans pain | Walk program | 3.3% | 1 |
Pain in extremity | Walk program | 3.3% | 1 |
Pain | Walk program | 3.3% | 1 |
Fall | No occurrence in use but causality cannot be denied | 3.3% | 1 |
Contusion | No occurrence in use but causality cannot be denied | 3.3% | 1 |