Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia.
Kim D Anderson, Radha Korupolu, Kristin E Musselman and 6 others
PMID 36188946WHAT IT FOUND
Functional electrical stimulation was not better than conventional therapy for self-care independence.
Both groups improved by about 2 points, a meaningful change, but there was no significant difference between them. The study was underpowered due to pandemic interruptions.
Key findings
01There was no statistically significant difference between FES therapy and conventional therapy on the primary outcome of self-care independence (SCIM-SC).
02Both groups gained a mean of 2 points on the self-care scale, which is considered a small meaningful change, and this improvement persisted at follow-up.
03Secondary outcomes for hand function and quality of life showed minimal gains in both groups with no statistically significant differences.
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 underpowered because it failed to reach the target sample size of 60, enrolling only 51 participants due to the COVID-19 pandemic. The pandemic caused significant interruptions, with 17 participants having their therapy paused for varying lengths of time, introducing variability in treatment delivery and assessment timing. Baseline data suggested the FES group had slightly more severe impairments and higher injury levels than the conventional therapy group, which could have affected the capacity for improvement. Conventional therapy was not standardized across sites, with therapists choosing from a wide range of activities, potentially introducing variability in the control group's treatment. The study included participants up to 8 years post-injury, a heterogeneous group with varying amounts of prior clinical therapy, which may have influenced outcomes.
Declared interests
The study was funded by the U.S. Army Medical Research and Materiel Command. The text does not explicitly state conflicts of interest for the authors regarding the device manufacturer (MyndTec), but the device was provided for the study.
The easy way to misread this
Do not conclude that FES is ineffective or useless. The study was underpowered and interrupted by the pandemic, and both groups improved meaningfully. The result is that FES was not *better* than conventional therapy in this specific context, not that it fails to help.