Journal-based CME article
Randomized Controlled Trial of Surface Peroneal Nerve Stimulation for Motor Relearning in Lower Limb Hemiparesis

https://doi.org/10.1016/j.apmr.2013.01.024Get rights and content

Abstract

Objective

To compare the motor relearning effect of a surface peroneal nerve stimulator (PNS) versus usual care on lower limb motor impairment, activity limitation, and quality of life among chronic stroke survivors.

Design

Single-blinded randomized controlled trial.

Setting

Teaching hospital of academic medical center.

Participants

Chronic stroke survivors (N=110; >12wk poststroke) with unilateral hemiparesis and dorsiflexion strength of ≤4/5 on the Medical Research Council scale.

Interventions

Subjects were stratified by motor impairment level and then randomly assigned to ambulation training with either a surface PNS device or usual care (ankle-foot orthosis or no device) intervention. Subjects were treated for 12 weeks and followed up for 6 months posttreatment.

Main Outcome Measures

Lower limb portion of the Fugl-Meyer (FM) Assessment (motor impairment), the modified Emory Functional Ambulation Profile (mEFAP) performed without a device (functional ambulation), and the Stroke Specific Quality of Life (SSQOL) scale.

Results

There was no significant treatment group main effect or treatment group by time interaction effect on FM, mEFAP, or SSQOL raw scores (P>.05). The time effect was significant for the 3 raw scores (P<.05). However, when comparing average change scores from baseline (t1) to end of treatment (t2, 12wk), and at 12 weeks (t3) and 24 weeks (t4) after end of treatment, significant differences were noted only for the mEFAP and SSQOL scores. The change in the average scores for both mEFAP and SSQOL occurred between t1 and t2, followed by relative stability thereafter.

Conclusions

There was no evidence of a motor relearning effect on lower limb motor impairment in either the PNS or usual-care groups. However, both the PNS and usual-care groups demonstrated significant improvements in functional mobility and quality of life during the treatment period, which were maintained at 6-month follow-up.

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.

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      Citation 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.

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    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.

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