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Original Contribution

Foot Drop Stimulation Versus Ankle Foot Orthosis After Stroke

30-Week Outcomes

Patricia M. Kluding, Kari Dunning, Michael W. O’Dell, Samuel S. Wu, Jivan Ginosian, Jody Feld, Keith McBride
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https://doi.org/10.1161/STROKEAHA.111.000334
Stroke. 2013;STROKEAHA.111.000334
Originally published May 2, 2013
Patricia M. Kluding
From the Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, Kansas City, KS (P.M.K.); Department of Rehabilitation Sciences, College of Allied Health Sciences, and Division of Biostatistics and Epidemiology, College of Medicine, University of Cincinnati, Cincinnati, OH (K.D.); Department of Rehabilitation Medicine, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY (M.W.O.); Department of Biostatistics, University of Florida, Gainesville, FL (S.S.W.); Bioness Inc, Valencia, CA (J.G., K.M.); and Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC (J.F.).
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Kari Dunning
From the Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, Kansas City, KS (P.M.K.); Department of Rehabilitation Sciences, College of Allied Health Sciences, and Division of Biostatistics and Epidemiology, College of Medicine, University of Cincinnati, Cincinnati, OH (K.D.); Department of Rehabilitation Medicine, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY (M.W.O.); Department of Biostatistics, University of Florida, Gainesville, FL (S.S.W.); Bioness Inc, Valencia, CA (J.G., K.M.); and Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC (J.F.).
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Michael W. O’Dell
From the Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, Kansas City, KS (P.M.K.); Department of Rehabilitation Sciences, College of Allied Health Sciences, and Division of Biostatistics and Epidemiology, College of Medicine, University of Cincinnati, Cincinnati, OH (K.D.); Department of Rehabilitation Medicine, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY (M.W.O.); Department of Biostatistics, University of Florida, Gainesville, FL (S.S.W.); Bioness Inc, Valencia, CA (J.G., K.M.); and Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC (J.F.).
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Samuel S. Wu
From the Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, Kansas City, KS (P.M.K.); Department of Rehabilitation Sciences, College of Allied Health Sciences, and Division of Biostatistics and Epidemiology, College of Medicine, University of Cincinnati, Cincinnati, OH (K.D.); Department of Rehabilitation Medicine, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY (M.W.O.); Department of Biostatistics, University of Florida, Gainesville, FL (S.S.W.); Bioness Inc, Valencia, CA (J.G., K.M.); and Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC (J.F.).
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Jivan Ginosian
From the Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, Kansas City, KS (P.M.K.); Department of Rehabilitation Sciences, College of Allied Health Sciences, and Division of Biostatistics and Epidemiology, College of Medicine, University of Cincinnati, Cincinnati, OH (K.D.); Department of Rehabilitation Medicine, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY (M.W.O.); Department of Biostatistics, University of Florida, Gainesville, FL (S.S.W.); Bioness Inc, Valencia, CA (J.G., K.M.); and Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC (J.F.).
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Jody Feld
From the Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, Kansas City, KS (P.M.K.); Department of Rehabilitation Sciences, College of Allied Health Sciences, and Division of Biostatistics and Epidemiology, College of Medicine, University of Cincinnati, Cincinnati, OH (K.D.); Department of Rehabilitation Medicine, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY (M.W.O.); Department of Biostatistics, University of Florida, Gainesville, FL (S.S.W.); Bioness Inc, Valencia, CA (J.G., K.M.); and Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC (J.F.).
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Keith McBride
From the Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, Kansas City, KS (P.M.K.); Department of Rehabilitation Sciences, College of Allied Health Sciences, and Division of Biostatistics and Epidemiology, College of Medicine, University of Cincinnati, Cincinnati, OH (K.D.); Department of Rehabilitation Medicine, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY (M.W.O.); Department of Biostatistics, University of Florida, Gainesville, FL (S.S.W.); Bioness Inc, Valencia, CA (J.G., K.M.); and Department of Community and Family Medicine, Duke University School of Medicine, Durham, NC (J.F.).
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Abstract

Background and Purpose—Drop foot after stroke may be addressed using an ankle foot orthosis (AFO) or a foot drop stimulator (FDS). The Functional Ambulation: Standard Treatment versus Electric Stimulation Therapy (FASTEST) trial was a multicenter, randomized, single-blinded trial comparing FDS and AFO for drop foot among people ≥3 months after stroke with gait speed ≤0.8 m/s.

Methods—Participants (n=197; 79 females and 118 males; 61.14±11.61 years of age; time after stroke 4.55±4.72 years) were randomized to 30 weeks of either FDS or a standard AFO. Eight dose-matched physical therapy sessions were provided to both groups during the first 6 weeks of the trial.

Results—There was significant improvement within both groups from baseline to 30 weeks in comfortable gait speed (95% confidence interval for mean change, 0.11–0.17 m/s for FDS and 0.12–0.18 m/s for AFO) and fast gait speed. However, no significant differences in gait speed were found in the between-group comparisons. Secondary outcomes (standard measures of body structure and function, activity, and participation) improved significantly in both groups, whereas user satisfaction was significantly higher in the FDS group than in the control group.

Conclusions—Using either an FDS or an AFO for 30 weeks yielded clinically and statistically significant improvements in gait speed and other functional outcomes. User satisfaction was higher in the FDS group. Although both groups did receive intervention, this large clinical trial provides evidence that FDS or AFO with initial physical therapy sessions can provide a significant and clinically meaningful benefit even years after stroke.

Clinical Trial Registration Information—URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01138995.

  • electric stimulation
  • foot drop stimulation
  • gait
  • orthosis
  • rehabilitation
  • stroke
  • Received December 5, 2012.
  • Accepted March 18, 2013.
  • © 2013 American Heart Association, Inc.

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    Foot Drop Stimulation Versus Ankle Foot Orthosis After Stroke
    Patricia M. Kluding, Kari Dunning, Michael W. O’Dell, Samuel S. Wu, Jivan Ginosian, Jody Feld and Keith McBride
    Stroke. 2013;STROKEAHA.111.000334, originally published May 2, 2013
    https://doi.org/10.1161/STROKEAHA.111.000334

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    Foot Drop Stimulation Versus Ankle Foot Orthosis After Stroke
    Patricia M. Kluding, Kari Dunning, Michael W. O’Dell, Samuel S. Wu, Jivan Ginosian, Jody Feld and Keith McBride
    Stroke. 2013;STROKEAHA.111.000334, originally published May 2, 2013
    https://doi.org/10.1161/STROKEAHA.111.000334
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