Table 3.
Adverse events detailed.
| References | Device | Adverse event description | AE occurrence | Severity | Category AE | Caused by | Caused dropouts |
|---|---|---|---|---|---|---|---|
| Borggraefe et al. (2010) | Lokomat | Muscle pain | 16 | Mild | Musculoskeletal | Not stated | No |
| Joint pain | 14 | Mild (12), moderate (2) | Musculoskeletal | Not stated | Yes (2) | ||
| Skin erythema | 12 | Mild | Soft tissue-related | Cuffs | No | ||
| Open skin lesions | 4 | Mild (2), moderate (1), severe (1) | Soft tissue-related | Cuffs | Yes (2) | ||
| Tendinopathy | 1 | Severe | Musculoskeletal | Not stated | Yes | ||
| Carda et al. (2012) | Lokomat | Mild discomfort | 3 | Mild | Soft tissue-related | Harness | No |
| Chin et al. (2010) | Lokomat | Discomfort and redness in groin area | A few | Mild | Soft tissue-related | Harness | No |
| Skin abrasions | 3 | Moderate | Soft tissue-related | Cuffs | No | ||
| Giddiness | 1 | Mild | Physiological | Not stated | No | ||
| Lower limb bruises | 1 | Moderate | Soft tissue-related | Cuffs | Yes | ||
| Fear of gait trainer | 1 | Moderate | Other | Not stated | Yes | ||
| Esquenazi et al. (2017) | Not stated (Lokomat or G-EO) | Skin irritation and pain | 4 | Unknown | Soft tissue-related/other | Not stated | No |
| Filippo et al. (2015) | Lokomat | Proximal tibia fracture | 1 | Severe | Musculoskeletal | Not stated | Not applicable |
| Freivogel et al. (2008) | LokoHelp | Discomfort in groin or armpit | 11 | Mild | Soft tissue-related | Harness | No |
| Discomfort in right hip | 1 | Mild | Musculoskeletal | Not stated | No | ||
| Lower back pain | 1 | Mild | Musculoskeletal | Not stated | No | ||
| Headache | 3 (1)a | Mild | Other | Not stated | No | ||
| Menstrual cramps | 1 | Mild | Other | Not stated | No | ||
| Knee pain | 1 | Moderate | Musculoskeletal | Not stated | No | ||
| Not described | 5 | Unknown | Unknown | Not stated | No | ||
| Freivogel et al. (2009) | LokoHelp | Discomfort | 33 | Unknown | Soft tissue-related | Mostly harness | No |
| Knee pain | 1 | Unknown | Musculoskeletal | Not stated | No | ||
| Geigle et al. (2013) | Lokomat | Atypical autonomic dysreflexia | 4 (1)a | Moderate | Physiological | Exercise (did not occur during pure suspension) | Yes (dropped out due to elevated BP) |
| Knee pain | 1 | Minor | Musculoskeletal | Not stated | |||
| Discomfort | 1 | Minor | Soft tissue-related | Harness | |||
| Husemann et al. (2007) | Lokomat | Skin lesions | 2 | Moderate | Soft tissue-related | Not stated | Yes |
| Ikumi et al. (2016) | HAL | Transient blood pressure change | 6 (1)a | Moderate | Physiological | Not stated | No |
| Jansen et al. (2018) | HAL | Skin reddening | 4 | Mild | Soft tissue-related | EMG electrodes, leg cuffs, shoes | No |
| Kelley et al. (2013a,b) | Lokomat | Skin changes (redness or broken skin) | 12 (5)a | Moderate | Soft tissue-related | Straps/cuffs | No |
| Morone et al. (2011) | GT | Severe symptomatic hypotension | 8 (3)a | Moderate | Physiological | Not stated | Not stated |
| Knee pain | 1 | Moderate | Musculoskeletal | Not stated | Not stated | ||
| Nilsson et al. (2014) | HAL | Knee/malleolus pain | 2 | Moderate | Musculoskeletal | Cuff pressure | No |
| Discomfort (feeling of being trapped) | 1 | Moderate | Other | Straps | No | ||
| Discomfort (shoulders) | 2 | Mild | Soft tissue-related | Straps | No | ||
| Sense of suit being heavy over lower back | 1 | Mild | Other | Weight of suit | No | ||
| Skin irritation | 1 | Mild | Soft tissue-related | EMG electrodes | No | ||
| Groin pain, chafing | 1 | Moderate | Soft tissue-related | Harness | No | ||
| Stoller et al. (2014, 2015) | Lokomat | Tibia skin lesion | 1 | Moderate | Soft tissue-related | Cuffs (padding) | Yes |
| Groin pain | 1 | Moderate | Soft tissue-related | Harness | Yes | ||
| High blood pressure | 2 (1)a | Moderate | Physiological | Not stated | No | ||
| Vaney et al. (2012) | Lokomat | Minor bruising | Some | Mild | Soft tissue-related | Straps | No |
a
When AE occurrence is presented as X (Y), X is the number of events, and Y is the number of subjects.