Journal-based CME articleRandomized Controlled Trial of Surface Peroneal Nerve Stimulation for Motor Relearning in Lower Limb Hemiparesis
Section snippets
Study design
A randomized controlled trial was performed comparing ambulation training with a surface PNS device (PNS group) to usual care (UC group). Subjects with chronic hemiparetic stroke were treated for 12 weeks (device usage period) and followed up for a total of 6 months posttreatment. Outcome assessments were performed at baseline (t1), end of the device usage period (t2), and at 12 weeks (t3) and 24 weeks (t4) posttreatment.
Participants
Subjects were recruited from a stroke rehabilitation outpatient program
Participants and baseline characteristics
Figure 1 shows the participant flow diagram. A total of 110 or 23% of screened stroke survivors satisfied inclusion criteria and enrolled in the study. We had a lower-than-expected recruitment rate, and thus we did not reach our target enrollment of 128. Nevertheless, with the conversion of the study from a 2 × 2 factorial design to a single-factor design, 110 subjects still translates to a power of 99% to detect the anticipated difference in FM scores between groups.
Baseline characteristics of
Discussion
The primary finding of this study was that the use of a surface PNS and usual care were not associated with improvements in motor relearning among chronic stroke survivors as measured by the LE FM. In addition, the use of a PNS was no more effective than usual care in improving ambulation function (mEFAP) or quality of life (SSQOL). However, both groups had significant improvements in ambulation function and quality of life during the treatment phase, which was maintained at 6 months.
In the
Conclusions
There was no evidence of a motor relearning effect on lower limb motor impairment in either the PNS or UC groups as measured by the FM. However, even in the chronic phase of stroke, both the PNS and UC groups demonstrated significant improvements in functional mobility and quality of life that were sustained at 6 months.
Suppliers
- a.
Odstock Medical Ltd, The National Clinical FES Centre, Salisbury District Hospital, Salisbury Wiltshire, SP2 8BJ, United Kingdom.
- b.
G A Guilford & Son Ltd Orthotics and Prosthetic Center, 13515 Brookpark Rd, Cleveland, OH 44142.
- c.
SAS Institute Inc, 100 SAS Campus Dr, Cary, NC 27513.
References (52)
- et al.
Clinical use of the Odstock dropped foot stimulator: its effect on the speed and effort of walking
Arch Phys Med Rehabil
(1999) - et al.
A randomized controlled trial of an implantable 2-channel peroneal nerve stimulator on walking speed and activity in poststroke hemiplegia
Arch Phys Med Rehabil
(2007) - et al.
Neuroprosthesis for footdrop compared with an ankle-foot orthosis: effects on postural control during walking
J Stroke Cerebrovasc Dis
(2009) Functional and structural plasticity in motor cortex: implications for stroke recovery
Phys Med Rehabil Clin N Am
(2003)- et al.
Effect of functional electrical stimulation on the effort and walking speed, surface electromyography activity, and metabolic responses in stroke subjects
J Electromyogr Kinesiol
(2010) - et al.
Changes in muscle activity in children with hemiplegic cerebral palsy while walking with and without ankle-foot orthoses
Gait Posture
(2006) - et al.
Electromyogram-triggered neuromuscular stimulation for improving the arm function of acute stroke survivors: a randomized pilot study
Arch Phys Med Rehabil
(1998) - et al.
A review of standing balance recovery from stroke
Gait Posture
(2005) - et al.
Guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association
Stroke
(2011) - et al.
Management of adult stroke rehabilitation care: a clinical practice guideline
Stroke
(2005)
The effects of common peroneal stimulation on the effort and speed of walking: a randomized controlled trial with chronic hemiplegic patients
Clin Rehabil
Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders
Neurorehabil Neural Repair
The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review
Artif Organs
Is transcutaneous peroneal stimulation beneficial to patients with chronic stroke using an ankle-foot orthosis? A within-subjects study of patients' satisfaction, walking speed and physical activity level
J Hehabil Med
Peroneal nerve stimulation versus an ankle foot orthosis for correction of footdrop in stroke: impact on functional ambulation
Neurorehabil Neural Repair
Mechanisms underlying functional recovery following stroke
Can J Neurol Sci
Improvement in functional ambulation as a therapeutic effect of peroneal nerve stimulation in hemiplegia: two case reports
Neurorehabil Neural Repair
Restoration of gait and motor recovery by functional electrical stimulation therapy in persons with stroke
Disabil Rehabil
Improvement of gait following functional electrical stimulation. I. Investigations on changes in voluntary strength and proprioceptive reflexes
Scand J Rehabil Med
A control study of muscle force recovery in hemiparetic patients during treatment with functional electrical stimulation
Scand J Rehabil Med
Functional electrical stimulation improves motor recovery of the lower extremity and walking ability of subjects with first acute stroke: a randomized placebo-controlled trial
Stroke
Experience of clinical use of the Odstock dropped foot stimulator
Artif Organs
Therapeutic effect of an implantable peroneal nerve stimulator in subjects with chronic stroke and footdrop: a randomized controlled trial
Phys Ther
Non-velocity-related effects of a rigid double-stopped ankle-foot orthosis on gait and lower limb muscle activity of hemiparetic subjects with an equinovarus deformity
Stroke
Potential predictors of motor and functional outcomes after distributed constraint-induced therapy for patients with stroke
Neurorehabil Neural Repair
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2018, Archives of Physical Medicine and RehabilitationCitation Excerpt :These 2 studies30,33 were assessed as low risk of bias because they provided a double blinding protocol in detail. However, 11 studies20,23,26,31-33,35,37-42 reported blinding of assessors and were assessed as low risk bias. All but 3 studies were assessed as low risk of bias in incomplete outcome data.
Supported by the National Institute of Child Health and Human Development (grant nos. R01HD44816, K23HD060689, and K24HD054600) and the National Institutes of Health National Center for Research Resources Clinical and Translational Science Collaborative of Cleveland (grant no. UL1RR024989).
A commercial party having a direct financial interest in the results of the research supporting this article has conferred or will confer a financial benefit on the author or 1 or more of the authors. Paul N. Taylor is the co-inventor of the PNS device evaluated in this study and is named on 2 patents for the device. The patents are assigned to Salisbury NHS Foundation Trust. He also holds shares in Odstock Medical Limited.
No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated (Sheffler, Gunzler, Buurke, IJzerman, Chae).
Clinical Trial Registration Number: NCT00148343.