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C. Shackleton et al.
and had tendencies towards strong positive comments
regarding the acceptability and emotional/health bene-
fits of the training process (11, 15, 16, 18, 19, 25–27).
Improvements in QoL and psycho-emotional wellness
were also reported post-intervention (7, 25). Despite
these positive perceptions, Benson et al. (7) showed
that the mean device form score of 41 points indicated
that participants initially had positive expectations of
using the exoskeleton, but not all these expectations
were met, as the mean study end-point score was 34.
This reduced satisfaction may be due to the few reports
that wearing or adjusting the device was not relatively
simple, and that there were no real improvements in
their bowel programmes. Unrealistic initial expecta-
tions and hopes of taking part in the RLT programme
may also play an important role in user-satisfaction.
Study limitations
This review highlights the underpowered evidence
base regarding the efficacy of RLT, primarily due to
the heterogeneity in the study characteristics and small
sample sizes. Significant bias further diminishes the
power of the findings and generalizability to clinical
practice. Six studies did not disclose their conflicts of
interest. The remaining 21 studies did discuss potential
biases, with 5 studies acknowledging competing inte-
rests, whereas the other 16 had none to declare. How­
ever, 9 of these 16 studies declared incorrectly, as they
did not acknowledge the conflicts of interest related
to being financially supported (11, 13) and receiving
salaries from exoskeleton companies (14, 19, 21, 22,
36) or performing the study to achieve FDA clearance
for the exoskeleton company (12, 24). It is relevant to
note that due to the high cost of the robotic devices,
subsidization is often required from the relevant com-
panies for access and/or maintenance of the devices.
This support is crucial to research being undertaken by
independent researchers, but the potential for reporting/
publication bias is therefore increased, as companies
try to gather evidence to support their devices.
This review indicates the need for well-designed,
randomized clinical trials (RCTs), with homogenous
samples and relevant control groups who received
more conventional gait training. Future studies should
be consistent in their training protocols and ensure ade-
quate intervention length to allow for more meaningful
comparisons. In addition, the inconsistency of outcome
reporting among studies exposes the necessity of develo-
ping standardized protocols and sensitive outcome mea-
sures to evaluate RLT interventions in people with SCI.
Conclusion
Clinical application of these assistive devices appears
promising as a tool to offer more comprehensive care
www.medicaljournals.se/jrm
for patients with SCI. This review indicates that RLT
can provide individuals with SCIs the ability to walk
safely while improving their walking performance as
well as improved health outcomes and psychological
well-being. Further large clinical trials with sufficient
rehabilitation durations, as well as adequately powered
homogenous studies, are required to better understand
these effects of RLT on individuals with SCI.
ACKNOWLEDGEMENTS
This Study was supported by the National Research Foundation
of South Africa, University of Cape Town and Oppenheimer
Memorial Trust.
The authors have no conflicts of interest to declare.
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