Table 3 .
Adverse events reporting in FES-enhanced exercise studies
| Study | Intervention | Adverse event definition provided | Method of adverse event data collection | Number of excluded participants and reason | Categories of adverse events reported | Adverse events (N) | All important or serious adverse events reported | Numerical data reported by intervention group? |
|---|---|---|---|---|---|---|---|---|
| Needham-Shropshire et al.33 | FES-ACE | No | Not reported | 0/34 | All | None | Yes | Yes |
| Wheeler et al.34 | FES-rowing ergometry | Yes. Safety concerns and injuries related to training | Prospective monitoring | 0/6 | Derm | None | Yes | Not applicable |
| MSK | ||||||||
| Duffell et al.35 | FES-LCE | No | Prospective monitoring | 0/11 | Derm | Skin reaction under electrodes (4) | Yes | Not applicable |
| Frotzler et al.36 | FES-LCE | No | Not reported | 1/11 Foot fracture unrelated to training | All | None | Unknown | Not applicable |
| Janssen and Pringle37 | FES-LCE | No | Prospective monitoring | 0/12 | CV | Lightheadedness in “some” subjects | Unknown | Not applicable |
| Zbogar et al.38 | FES-LCE | No | Prospective monitoring | 2/6 | CV | Mild AD symptoms (3) | Unknown | Not applicable |
| Transportation (1) | ||||||||
| “Illness” (1) | ||||||||
| Hjeltnes et al.39 | FES-LCE | No | Prospective monitoring | 1/6 Urinary tract complications | CV | None | Yes | Not applicable |
| Mutton et al.40 | FES-LCE | No | Spontaneous reporting | 0/11 | All | None | Yes | Not applicable |
| Mohr et al.41 | FES-LCE | Yes | Prospective monitoring | 0/10 | All | Small hematoma in quadriceps (1) | Yes | Not applicable |
| Post-exercise hypotension, (3) | ||||||||
| Barstow et al.42 | FES-LCE | No | Not reported | 0/9 | All | None | Unknown | Not applicable |
| Hooker et al.43 | FES-LCE | No | Prospective/routine monitoring | 0/8 | CV | None | Unknown | Not applicable |
| Ragnarsson et al.44,45 | FES-LCE | Yes. Risks of training with FES-LCE in people w/ SCI and subjective response to program | Prospective/ routine monitoring | 0/30 | All | None | Yes | Not applicable |
| Brissot et al.46 | FES-ambulation (parastep) | No | Not reported | 2/15 | Derm | Transient ankle edema (4) | Yes | Not applicable |
| Pain due to electric stimulation (1) pressure ulcer (1) | MSK | Lumbar pain (4) (3 with prior hx). | ||||||
| Pain | Four falls in 3 participants, 1 caused sacral FX (3) | |||||||
| Falls | ||||||||
| Klose et al.47 and Needham-Shropshire et al.48 | FES-Ambulation (Parastep) | No | Not reported | 0/16 | All | None | Unknown | Not applicable |
| Gallien et al.49 | FES-ambulation (Parastep) | Yes. Complications of FES walking | Prospective/routine monitoring | 1/13 Calcaneum FX | MSK | Calcaneus FX (1) | Unknown | Not applicable |
| Falls | Sacral FX (1) | |||||||
| Pain | Back pain (2) benign ankle sprain (2) | |||||||
| Field-Fote50 | FES-ambulation (BWSTT) | No | Not reported | 0/19 | All | None | Yes | Not applicable |
| Ferro et al.51 | FES – ambulation (BWSTT) | Yes. Knee injury caused by FES treadmill training | Prospective/routine monitoring | 0/9 | MSK (knee only) | Meniscal tears (2) medial condyle contusion (1) Medial collateral ligament tear (1) | No | Not applicable |
| Thoumie et al.52 | FES-ambulation (RGO) | Yes. Complications related to the training program | Prospective routine monitoring | 5/26 | All | Spontaneous tibia FX (1) | Yes | Not applicable |
| Syringomyelia (1), spontaneous FX of both legs (1) | Skin breakdown (4) (causing 2 to drop out) | |||||||
| pressure ulcers (2), | Mild orthostatic hypotension (21) | |||||||
| tibial FX during training (1) |
ACE, arm cycle ergometry; AD, autonomic dysreflexia; BP, blood pressure; BWSTT, body weight supported treadmill training; CV, cardiovascular; Derm, dermatological; FES, functional electrical stimulation; FX, fracture; HR, heart rate; Hx, history; LCE, leg cycle ergometry; MSK, musculoskeletal; RGO, reciprocating gait orthosis; WCE, wheelchair ergometry; WUSPI, wheelchair users shoulder pain index.