Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III).
Mohamed Sakel, Karen Saunders, Philip Hodgson and 4 others
PMID 36484722WHAT IT FOUND
People with MS completed a powered exoskeleton balance programme without serious harm attributed to the device.
Some reported that MS affected daily life less and that quality of life improved. No control group means benefit from the device is unproven.
Key findings
01Ten of eleven participants completed the trial, and four adverse events, including one serious adverse event, were not directly attributable to the trial.
02Four participants achieved a clinically significant improvement in balance, but the group mean Berg Balance Scale change was not statistically significant.
03There was no control group, so equivalent benefit from the exercise sessions without the exoskeleton device cannot be excluded.
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
This was a single-arm preliminary study with no control group, so the exoskeleton cannot be separated from the exercise programme delivered within it. Only 11 participants were enrolled and 10 completed, which is too small to establish treatment efficacy. Participants varied widely from walking independently with a stick to needing a hoist for transfers, making group patterns hard to interpret. Many secondary outcomes were tested, and the authors noted that some changes could have occurred by chance. The intervention was limited to four sessions because of resources, so the dose needed for benefit is unknown. Screening excluded many potential participants for device fit, especially calf muscle bulk exceeding 375 mm, so results apply only to people who can physically fit the device. All participants were White, so applicability to other populations is not established. One participant withdrew after a multiple sclerosis relapse, which is common in relapsing remitting MS and not necessarily caused by the trial.
Declared interests
The supplied text does not include a funding or conflict-of-interest declaration. It identifies the Rex Bionics Ltd exoskeleton and lists NIHR and NHS Trust registration references, but it does not state who funded the study or whether authors declared competing interests.
The easy way to misread this
Do not read the improvements in balance, MS impact or quality of life as proof that the exoskeleton works. This was a single-group study with no control group, and the authors noted that multiple secondary outcomes could have changed by chance.