Table 3. Adverse events.
| Adverse event (AE) type | Count | Event rate per 1000 h.* |
|---|---|---|
| Fall | 0 | 0 |
| Instability (no fall) | 0 | 0 |
| Skin integrity issues | 3 | 111 |
| Bruising | 0 | 0 |
| Skin abrasion | 2 | 74 |
| Pressure injuries | 0 | 0 |
| Soft tissue injury | 0 | 0 |
| Tissue/skin reaction from device-skin contact | 1 | 37 |
| Soft tissue injury | 0 | 0 |
| Blood pressure issues | 5 | 185 |
| Systolic hypertension (140 ≥ mmHg) | 2 | 74 |
| Systolic hypotension (<90 mmHg) | 3 | 111 |
| Mechanical/electrical issues | 3 | 111 |
| Premature battery failure | 1 | 37 |
| Electrical shock | 0 | 0 |
| Burns | 0 | 0 |
| Device malfunction resulting in unanticipated operation | 1 | 37 |
| Device breakdown | 1 | 37 |
| Use error | 1 | 37 |
| Participant error | 0 | 0 |
| Researcher error | 1 | 37 |
| Companion error | 0 | 0 |
| Additional pain from exoskeleton-assisted walking | 0 | 0 |
| Other | 0 | 0 |
*Event rates are standardized per 1000 h of exposure to standing, walking, and sitting in the powered exoskeleton, for an average of 38.05 min exposure per session for all 43 sessions completed by 12 participants (27.27 h).