Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations.
Mark Andrew Wright, Franziska Herzog, Anna Mas-Vinyals and 8 others
PMID 37046307WHAT IT FOUND
The ABLE exoskeleton was safe and feasible for 24 people with spinal cord injury.
No falls occurred, and donning took about seven minutes. Walking independence improved, but without a control group, these gains may reflect natural recovery or standard therapy rather than the device itself.
Key findings
01No serious adverse events, falls, or fractures occurred, with only 8 device-related adverse events across 242 sessions.
02Donning and doffing the device required an average total time of 6 minutes and 50 seconds.
03The study was open-label and non-controlled, so improvements in walking metrics cannot be attributed solely to the exoskeleton.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTs
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What it does not show
The study was open-label and non-controlled, meaning selection bias and natural recovery cannot be ruled out as causes for improvement. The sample size was small (n=24) and heterogeneous, including both acute and chronic injuries, which lowers statistical power. Most participants were in the acute or subacute phase, where spontaneous neurological recovery is common, making it impossible to attribute functional gains solely to the exoskeleton. The study did not compare the ABLE exoskeleton against standard care or another device, so relative efficacy is unknown.
Declared interests
The study was funded by EIT Health and Universitätsklinikum Heidelberg. No specific conflicts of interest regarding the device manufacturer were explicitly declared in the provided text, but the study followed medical device regulations (ISO 14155).
The easy way to misread this
Do not interpret the improvements in walking speed and distance as proof that the ABLE exoskeleton is superior to standard rehabilitation. The study had no control group, and many participants were in the early stages of injury where spontaneous recovery and concurrent conventional therapy are expected to drive functional gains.