Stephanie A Kolakowsky-Hayner, James Crew, Shonna Moran and Akshat Shah
Objective: Evaluate feasibility and safety of EksoTM to aid ambulation in individuals with SCI.
Design: Prospective pilot study.
Setting: SCI Rehabilitation Center Outpatient Gym.
Participants: Eight individuals, at least 18 years of age, with complete T1 SCI or below, within 2 years of injury, completed initial inpatient rehabilitation. All participants signed informed consent, had been cleared from requiring spinal orthoses, met inclusion criteria, and were pre-screened based on device requirements and medical stability.
Intervention: Six weekly sessions with graduated time and less assistance in the EksoTM device.
Outcome Measures: Skin evaluation, blood pressure, pain level, spasticity, time and level of assistance needed to transfer into and donn device; time ambulating; time up in device; assistive devices used during ambulation; step length; distance walked; level of assistance during use; and level of assistance needed to doff and transfer out of device.
Results: No major skin effects, minimal pain reports, no known fractures, swelling, or other adverse events. Level of assistance ranged from dependent to moderate independent, average set up time was 18.13 minutes, loss of balance and falls were infrequent.
Conclusions: Bionic exoskeletons such as EksoTM are safe for those with complete thoracic SCI in a controlled environment, in the presence of experts, and may eventually enhance mobility in those without volitional lower extremity function. There appears to be a training effect in the device but further trials are needed. Future studies of bionic exoskeletons as gait training devices are warranted. Future studies of bionic exoskeletons as a clinical tool to alleviate secondary complications should be considered.
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Journal of Spine received 2022 citations as per Google Scholar report
