PMID- 24412265
OWN - NLM
STAT- MEDLINE
DCOM- 20150421
LR  - 20161125
IS  - 1934-1563 (Electronic)
IS  - 1934-1482 (Linking)
VI  - 6
IP  - 7
DP  - 2014 Jul
TI  - Response and prediction of improvement in gait speed from functional electrical 
      stimulation in persons with poststroke drop foot.
PG  - 587-601; quiz 601
LID - S1934-1482(14)00013-6 [pii]
LID - 10.1016/j.pmrj.2014.01.001 [doi]
AB  - OBJECTIVE: To describe changes in and predictors of comfortable gait speed (GS-C) 
      after using a foot-drop stimulator (FDS; Bioness L300; Bioness Inc, Valencia, CA) 
      for 42 weeks in persons who had sustained a stroke. DESIGN: Secondary analysis of 
      prospective assessments. SETTING: Multicenter clinical trial. PARTICIPANTS: A 
      total of 99 subjects who had sustained a stroke >/= 3 months earlier and who had 
      GS-C </= 0.8 m/s and drop foot with a mean age of 60.7 years and a poststroke time 
      of 4.8 years. METHODS: GS-C was assessed at baseline and at 30 weeks with and 
      without use of an FDS (therapeutic effect) and at 6, 12, 30, 36, and 42 weeks 
      with use of an FDS (total effect). After subjects participated in 8 physical 
      therapy sessions, an FDS was used for ambulation over the course of 42 weeks. 
      MAIN OUTCOME MEASUREMENTS: Changes in mean GS-C over time, FDS "responder" status 
      defined as either >/= 0.1 m/s gain in GS-C (the minimal clinically important 
      difference [MCID]) or advancing by one Perry Ambulation Category (PAC), and the 
      incidence and nature of adverse events (AEs). RESULTS: A total of 74 (75%) and 69 
      (70%) of 99 subjects completed assessments at 30 weeks and 42 weeks, 
      respectively. Baseline GS-C was 0.42 m/s without use of an FDS and 0.49 m/s with 
      use of an FDS. GS-C improved to 0.54 m/s at 30 weeks without use of an FDS 
      (effect size = 0.75) and 0.54, 0.55, 0.58, 0.60, and 0.61 m/s at 6, 12, 30, 36, 
      and 42 weeks with use of an FDS, respectively (effect size 0.84 at 42 weeks). 
      Half of the subjects achieved a maximum GS-C by 12 weeks. Approximately 18% were 
      PAC responders and 29% were MCID responders for 30-week therapeutic effect, and 
      55% were PAC responders and 67% were MCID responders for 42-week total effect. 
      After logistic regression, the following factors emerged as the strongest 
      predictors of FDS responders: younger age, faster baseline GS-C and Timed Up and 
      Go, and balance. At 42 weeks, 60% reported a device-related AE; 92% were mild and 
      96% were anticipated. CONCLUSIONS: When an FDS was used, GS-C improved 
      progressively over 42 weeks, with >/= 50% of patients achieving a clinically 
      meaningful 42-week total effect and 50% achieving a maximum GS-C by 12 weeks. 
      Younger patients with greater mobility levels may benefit most from use of an 
      FDS. AEs were frequent, mild, and reversible.
CI  - Copyright (c) 2014 American Academy of Physical Medicine and Rehabilitation. 
      Published by Elsevier Inc. All rights reserved.
FAU - O'Dell, Michael W
AU  - O'Dell MW
AD  - Department of Rehabilitation Medicine, New York-Presbyterian Hospital/Weill 
      Cornell Medical Center, Box 142, Room Baker F1600, 525 East 68th ST, New York, NY 
      10065( *). Electronic address: Mio2005@med.cornell.edu.
FAU - Dunning, Kari
AU  - Dunning K
AD  - Department of Rehabilitation Sciences, College of Allied Health Sciences, 
      Division of Biostatistics and Epidemiology, College of Medicine, University of 
      Cincinnati, Cincinnati, OH(dagger).
FAU - Kluding, Patricia
AU  - Kluding P
AD  - Department of Physical Therapy and Rehabilitation Sciences, University of Kansas 
      Medical Center, Kansas City, KS(double dagger).
FAU - Wu, Samuel S
AU  - Wu SS
AD  - Department of Biostatistics, University of Florida, Gainesville, FL( section sign).
FAU - Feld, Jody
AU  - Feld J
AD  - Department of Community and Family Medicine, Duke University School of Medicine, 
      Durham, NC( paragraph sign).
FAU - Ginosian, Jivan
AU  - Ginosian J
AD  - Department of Clinical Research, Bioness Inc, Valencia, CA( ||).
FAU - McBride, Keith
AU  - McBride K
AD  - Department of Marketing, Bioness Inc, Valencia, CA( * *).
LA  - eng
SI  - ClinicalTrials.gov/NCT01138995
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20140109
PL  - United States
TA  - PM R
JT  - PM & R : the journal of injury, function, and rehabilitation
JID - 101491319
SB  - IM
EIN - PM R. 2014 Oct;6(10):967
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Electric Stimulation Therapy/*methods
MH  - Female
MH  - Follow-Up Studies
MH  - Gait/*physiology
MH  - Gait Disorders, Neurologic/etiology/physiopathology/*therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Recovery of Function/*physiology
MH  - Stroke/*complications/physiopathology
MH  - Stroke Rehabilitation
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2014/01/15 06:00
MHDA- 2015/04/22 06:00
CRDT- 2014/01/14 06:00
PHST- 2013/06/19 00:00 [received]
PHST- 2013/12/20 00:00 [revised]
PHST- 2014/01/01 00:00 [accepted]
PHST- 2014/01/14 06:00 [entrez]
PHST- 2014/01/15 06:00 [pubmed]
PHST- 2015/04/22 06:00 [medline]
AID - S1934-1482(14)00013-6 [pii]
AID - 10.1016/j.pmrj.2014.01.001 [doi]
PST - ppublish
SO  - PM R. 2014 Jul;6(7):587-601; quiz 601. doi: 10.1016/j.pmrj.2014.01.001. Epub 2014 
      Jan 9.