Implanted Peroneal Nerve Stimulator Treatment for Drop Foot Caused by Central Nervous System Lesion: A Twelve-Month Follow-up of 21 Patients.
Kaare Severinsen, Kurt Grey, Anne Haase Juhl and 4 others
PMID 35451494WHAT IT FOUND
Patients with drop foot from central nervous system lesions reported high satisfaction and perceived performance gains after implanted peroneal nerve stimulation.
Walking speed and endurance improved slightly. This was an uncontrolled study of 21 patients, so it shows what happened, not that the device caused the change.
Key findings
01Self-perceived performance and satisfaction with performance improved significantly at follow-up, with median increases of 2.8 and 4.2 points on the 10-point COPM scale.
02Walking velocity increased by 0.1 m/s and walking distance by 33 m at follow-up, which the authors describe as clinically meaningful changes.
03The study design was uncontrolled and unblinded, with no comparison group, making it difficult to attribute improvements solely to the stimulation rather than time or learning effects.
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 uncontrolled and unblinded, meaning improvements could be due to time, learning, or placebo effects rather than the stimulation itself. Participants could feel the stimulation, making blinding impossible and increasing the risk of bias in self-reported outcomes. The study combined data from a phase III trial and a clinical cohort, with varying follow-up periods (6 to 12 months), which complicates direct comparison. There was no systematic tracking of home-based rehabilitation or other concurrent therapies, so the contribution of the device versus other activities cannot be isolated. The ActiGait® device is no longer commercially available, limiting the generalizability of the findings to current clinical practice. The sample size was small (21 patients) and heterogeneous in terms of lesion type and cause of drop foot.
Declared interests
The first 10 patients participated in a manufacturer-supported phase III feasibility study. The remaining 11 patients were financed by the Danish healthcare system. No other specific conflicts of interest were declared in the provided text.
The easy way to misread this
Do not conclude that the implanted stimulator caused the observed improvements in walking or satisfaction. The study had no control group, was unblinded, and did not track other rehabilitation activities, so the gains may reflect natural recovery, learning effects, or concurrent therapies rather than the device itself.