Skip to main content

Table 6 Incidence of causally-related adverse events during the trial period of the present study

From: Cybernic treatment with wearable cyborg Hybrid Assistive Limb (HAL) improves ambulatory function in patients with slowly progressive rare neuromuscular diseases: a multicentre, randomised, controlled crossover trial for efficacy and safety (NCY-3001)

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