A randomized controlled trial of an implantable 2-channel peroneal nerve stimulator on walking speed and activity in poststroke hemiplegia.
OBJECTIVE
To determine the effect of a new implantable 2-channel peroneal nerve stimulator on walking speed and daily activities, in comparison with the usual treatment in chronic stroke survivors with a drop foot.


METHODS
Randomized controlled trial.


METHODS
All subjects were measured 5 times in the gait laboratory.


METHODS
Twenty-nine stroke survivors with chronic hemiplegia with drop foot who fulfill the predefined inclusion and exclusion criteria were included in the study.


METHODS
The intervention group received an implantable 2-channel peroneal nerve stimulator for correction of their drop foot. The control group continued using their conventional walking device, consisting of an ankle-foot orthosis, orthopedic shoes, or no device.


METHODS
Walking speed, assessed both by a six-minute walk test (6MWT) and by using a 10-m walkway, was selected as primary outcome measure and activity monitoring data, consisting of percentage time spent on stepping, standing, and sitting/lying were selected as secondary outcome measure.


RESULTS
Functional electric stimulation (FES) resulted in a 23% improvement of walking speed measured with the 6MWT, whereas the improvement in the control group was only 3% (P=.010). Comfortable walking speed measured on a 10-m walkway was also significantly improved in favor of FES (P=.038). The percentage time spent on stepping deteriorated with 3% in the intervention and 0.8% in control group, which was not statistically significant between both groups (P=.13).


CONCLUSIONS
The present study shows a clinically relevant effect of the implantable 2-channel peroneal nerve stimulator on walking speed in the sample of stroke survivors included in our study.
Roessingh Research and Development, Enschede, The Netherlands. a.kottink@rrd.nl
Anke I
AI
Kottink
Hermie J
HJ
Hermens
Anand V
AV
Nene
Martin J
MJ
Tenniglo
Hans E
HE
van der Aa
Hendrik P
HP
Buschman
Maarten J
MJ
Ijzerman
D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D004567:Electrodes, Implanted; D004867:Equipment Design; D005080:Exercise Test; D005260:Female; D005500:Follow-Up Studies; D005528:Foot / Q000294:innervation*; D006429:Hemiplegia / Q000209:etiology / Q000503:physiopathology / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010543:Peroneal Nerve; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome; D016138:Walking / Q000502:physiology*