Physiotherapy using a free-standing robotic exoskeleton for patients with spinal cord injury: a feasibility study.
Nicola Postol, Neil J Spratt, Andrew Bivard and 1 others
PMID 34953501WHAT IT FOUND
Three patients with severe spinal cord injury completed 12 weeks of free-standing exoskeleton therapy.
No adverse events occurred, and all wanted to continue. Functional outcomes were inconsistent: one improved, one declined, and one showed no change on the primary measure.
Key findings
01The intervention was safe and feasible, with no adverse events and high retention among the three participants who started the 12-week program.
02The primary outcome of functional ability was inconsistent: one participant improved, one did not change, and one deteriorated.
03Recruitment was difficult, with only three of forty-one screened participants completing the trial due to eligibility constraints.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTsWhat it means for SLPs
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What it does not show
The sample size was extremely small (n=3), preventing any statistical analysis or generalisation of results. Recruitment was very poor, with only 7 of 41 screened participants being eligible, largely due to strict size and mobility criteria. Participants continued their regular physiotherapy and home exercise programs during the study, making it impossible to separate the effect of the exoskeleton from other concurrent treatments. Clinical stability was not demonstrated during the waitlist phase, as some outcome measures changed before the intervention even began. The study lacked a control group, so improvements or declines could be due to natural history or other factors.
Declared interests
The study was conducted by researchers at Hunter New England Health and the University of Newcastle. The device used was provided by Rex Bionics. The text does not explicitly state financial funding sources or conflicts of interest declarations beyond the institutional affiliations and the use of the commercial device.
The easy way to misread this
Do not conclude that the exoskeleton caused the functional improvements seen in one participant. The study was too small and unblinded to determine efficacy, and concurrent physiotherapy may have contributed to the changes.