Archives of Physical Medicine and Rehabilitation
Volume 88, Issue 8 , Pages 971-978, August 2007

A Randomized Controlled Trial of an Implantable 2-Channel Peroneal Nerve Stimulator on Walking Speed and Activity in Poststroke Hemiplegia

  • Anke I. Kottink, MSc

      Affiliations

    • Roessingh Research and Development, Enschede, The Netherlands
    • Corresponding Author InformationReprint requests to Anke I. Kottink, MSc, Roessingh Research and Development, PO Box 310, 7500 AH, Enschede, The Netherlands
  • ,
  • Hermie J. Hermens, PhD

      Affiliations

    • Roessingh Research and Development, Enschede, The Netherlands
    • Institute for Biomedical Technology, University of Twente, Enschede, The Netherlands
  • ,
  • Anand V. Nene, MD, PhD

      Affiliations

    • Roessingh Research and Development, Enschede, The Netherlands
    • Roessingh Rehabilitation Center, Enschede, The Netherlands
  • ,
  • Martin J. Tenniglo, PT

      Affiliations

    • Roessingh Rehabilitation Center, Enschede, The Netherlands
  • ,
  • Hans E. van der Aa, MD, PhD

      Affiliations

    • Department Neurosurgery Medisch Spectrum Twente, Enschede, The Netherlands
    • Twente Institute for Neuromodulation, Medisch Spectrum Twente, Enschede, The Netherlands
  • ,
  • Hendrik P. Buschman, PhD

      Affiliations

    • Department Neurosurgery Medisch Spectrum Twente, Enschede, The Netherlands
    • Twente Institute for Neuromodulation, Medisch Spectrum Twente, Enschede, The Netherlands
    • Biomedical Signals & Systems, University of Twente, Enschede, The Netherlands.
  • ,
  • Maarten J. IJzerman, PT, PhD

      Affiliations

    • Roessingh Research and Development, Enschede, The Netherlands
    • Institute for Biomedical Technology, University of Twente, Enschede, The Netherlands

Abstract 

Kottink AI, Hermens HJ, Nene AV, Tenniglo MJ, van der Aa HE, Buschman HP, IJzerman MJ. 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.

Design

Randomized controlled trial.

Setting

All subjects were measured 5 times in the gait laboratory.

Participants

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

Intervention

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.

Main Outcome Measures

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.

Key Words: Electric stimulation, Foot, Peroneal nerve, Rehabilitation, Stroke, Walking

 

 Supported by the European Eureka program, the Department of Dutch Ministry of Economic Affairs in The Hague, The Netherlands; the Ministry of Health, Welfare and Sport in The Hague, The Netherlands; and St Hubertus Foundation, The Netherlands.

 No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the authors or upon any organization with which the authors are associated.

PII: S0003-9993(07)00328-0

doi:10.1016/j.apmr.2007.05.002

Archives of Physical Medicine and Rehabilitation
Volume 88, Issue 8 , Pages 971-978, August 2007