Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid.
Nick Birch, Jon Graham, Tom Priestley and 5 others
PMID 28629390WHAT IT FOUND
In the first 20 people with spinal cord injury, a single supervised REX exoskeleton session was feasible: all transferred in, 19 did upright upper-body exercises, and no device-related adverse events occurred.
Key findings
01All 20 participants transferred into the REX device, with transfer times ranging from 230 to 1007 seconds.
02Nineteen participants completed both sets of upper-body exercises; the one who did not had severe spinal deformity.
03No device-related adverse events occurred, and 18 participants achieved autonomous control of the device.
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
The report is only the first interim analysis of 20 participants, so the sample is small. It was open-label and non-comparative, with no control group, so it cannot show that REX caused any benefit. Participants were assessed in a single session with no post-intervention follow-up. Only highly motivated people volunteered, so selection bias is likely. Subgroup numbers, especially tetraplegia and incomplete lesions, were small and skewed, so differences by injury level and completeness cannot be interpreted. The range of upper-body exercises was limited to what first-time users could do in one session.
Declared interests
Rex Bionics Plc, the maker of the REX device, is named as the funder.
The easy way to misread this
Do not conclude that the REX exoskeleton improves walking, function, or long-term health. This was a 20-participant interim feasibility report of a single supervised session, with no control group, no follow-up, likely selection bias, and funding by the device maker, so it shows only that transfer, exercise and device use were possible and that no device-related adverse events were reported.