The Reciprocating Gait Orthosis (RGO) (or variants of it) is the most common bilateral HKAFO for people with thoracic injuries. In most cases, experimental conditions involving activities without an RGO would not be possible for the participant, and thus, the RGO permits ambulation and in some cases, stairs to be performed.
None of the studies investigating the effectiveness of the braces for upright support and mobility are randomized using a control group without any brace/device, but that is in part due to the ethical dilemma of providing safe and appropriate bracing, and in many cases, participants would not be able to walk safely without the brace. Several studies compare two or more different types of devices, and in some cases (e.g. Arazpour et al. 2013b), the conditions were randomized during the testing. Some of the studies did provide a substantial training period (e.g., 5 times/week gait training sessions with braces for at least 2 weeks). Overall, these studies provided level 4 evidence that HKAFOs may help people with subacute or chronic complete paraplegia to stand independently and to achieve some functional ambulation skills, such as stepping up on curbs or climbing stairs with assistive devices. The maximum walking speeds achieved with orthosis use ranged from 0.13 to 0.63 m/s (Nakazawa et al. 2004; Massucci et al. 1998; Harvey et al. 1997; Saitoh et al. 1996; Sykes et al. 1996b; Thoumie et al. 1995; Winchester et al. 1993; Whittle et al. 1991), which is 13 to 57% of the optimal speed (1.1 m/s) required for successful community ambulation (Robinett and Vondran 1988). In general, however, the use of any of the braces investigated in these studies did not greatly enhance the ability of complete paraplegic subjects to be fully independent for functional community ambulation (Scivoletto et al. 2000; Harvey et al. 1997; Hong et al. 1990). In a few studies, some subjects demonstrated the ability to climb up and down stairs with the assistance of crutches or walkers (Franceschini et al. 1997; Harvey et al. 1997; Whittle et al. 1991). Thus, the greatest benefit derived from orthosis/brace use is from enhanced home or indoor mobility, general exercise and health benefits, and psychological benefits from attaining upright posture and standing (Sykes et al. 1996b; Hong et al. 1990; Mikelberg and Reid 1981).
The successful use of orthoses/braces is also dependent on other more individual and practical factors. It has been recommended that orthoses or braces are best for people who are well-motivated, with complete SCI at T9 or below or incomplete SCI at any level, with good postural control and a good level of fitness (Franceschini et al. 1997; Thoumie et al. 1995; Hong et al. 1990). Suzuki et al. (2007) showed that injury level, age, motivation, upper extremity strength, as well as spasticity and contractures were predictive of gait outcomes in long-leg brace users. Medical problems such as limited thoracolumbar mobility or mechanical back pain, or any musculoskeletal problems that make standing upright uncomfortable also tend to interfere with successful use of these orthoses/braces (Harvey et al. 1997; Middleton et al. 1997).
The ability for a patient to don/doff the orthosis without difficulty and relatively quickly (e.g. <5 minutes) also appears to enhance the probability of their acceptance (Scivoletto et al. 2000; Franceschini et al. 1997; Harvey et al. 1997; Saitoh et al. 1996; Thoumie et al. 1995; Hong et al. 1990; Mikelberg and Reid 1981). Frequent reports of technical problems (e.g. mechanical breakdown at the hinges, improper fitting) across many studies (Scivoletto et al. 2000; Harvey et al. 1997; Thoumie et al. 1995; Whittle et al. 1991; Mikelberg and Reid 1981) suggest that appropriate technical support of these mechanical devices is necessary to enhance ongoing use of these braces (Whittle et al. 1991).
Overall, it appears that most subjects feel that the difficulties and inconvenience encountered with orthoses/braces and the modest increase in function do not warrant their acceptance for regular, daily use in functional activities (Harvey et al. 1997; Sykes et al. 1996b; Hong et al. 1990; Mikelberg and Reid 1981). It has been suggested that the therapeutic benefits of orthosis-use (e.g. health benefits from standing practice) should be stressed to patients rather than setting forth an expectation that they will enhance functional ambulation and be a replacement for wheelchair-use (Franceschini et al. 1997).
There is level 4 evidence (see Table 11) that a reciprocating gait orthosis can enable walking in people with thoracic lesions, although not at speeds sufficient for community ambulation.