Effects of cardiac rehabilitation with motion assistance from a wearable cyborg hybrid assistive limb on patients with chronic heart failure: a randomized controlled trial with a one-year follow-up.
Hiroki Watanabe, Akira Koike, Hidenori Kato and 7 others
PMID 36744202WHAT IT FOUND
Adding a wearable lumbar support device to sit-to-stand exercises did not reduce heart failure readmissions or deaths over one year compared to standard exercise.
The device was safe, but the small sample size means it cannot prove whether the technology offers any long-term benefit.
Key findings
01There was no significant difference in the rate of rehospitalization due to heart failure exacerbation between the group using the wearable device and the control group after one year.
02The wearable device was safe to use, with no adverse events occurring during the intervention period in either group.
03The study had a very small sample size, with only 24 patients analyzed, which limits the ability to detect differences in long-term outcomes.
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 study included only 24 patients, which is too small to reliably detect differences in long-term outcomes like rehospitalization. The intervention period was short (6-10 days), which may not be sufficient to produce lasting changes in prognosis. Functional assessments were not blinded, introducing potential observer bias. The authors note that many confounding factors, such as medication and diet, influence heart failure outcomes and were not controlled for in this specific comparison.
Declared interests
The study was funded in part by a Japanese government grant. Two authors have significant financial ties to CYBERDYNE Inc., the manufacturer of the HAL device: one is a co-founder and shareholder, and the other is the founder, CEO, and inventor. The authors state that the company was not involved in the study design, data analysis, or writing.
The easy way to misread this
Do not conclude that the wearable device is ineffective for all purposes; the null result applies only to long-term readmission and mortality in a very small sample. The study may be underpowered to detect a benefit, and previous data suggested short-term strength improvements.