title: Early or delayed provision of an ankle-foot orthosis in patients with acute and subacute stroke: a randomized controlled trial.
abstract: OBJECTIVE
  (1) To study the effects of providing ankle-foot orthoses in subjects with (sub)acute stroke; and (2) to study whether the point in time at which an ankle-foot orthosis is provided post-stroke (early or delayed) influences these effects.
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  Rehabilitation centre.
  
  
  METHODS
  Unilateral hemiparetic stroke subjects with indication for use of an ankle-foot orthosis and maximal six weeks post-stroke.
  
  
  METHODS
  Subjects were randomly assigned to: early provision (at inclusion; Week 1) or delayed provision (eight weeks later; Week 9).
  
  
  METHODS
  10-metre walk test, 6-minute walk test, Timed Up and Go Test, stairs test, Functional Ambulation Categories, Berg Balance Scale, Rivermead Mobility Index and Barthel Index; assessed in Weeks 1, 3, 9 and 11.
  
  
  RESULTS
  A total of 33 subjects were randomized (16 early, 17 delayed). Positive effects of ankle-foot orthoses were found two weeks after provision, both when provided early (significant effects on all outcomes) or delayed (Berg Balance Scale p = 0.011, Functional Ambulation Categories p = 0.008, 6-minute walk test p = 0.005, Timed Up and Go Test p = 0.028). Comparing effects after early and delayed provision showed that early provision resulted in increased levels of improvement on Berg Balance Scale (+5.1 points, p = 0.002), Barthel Index (+1.9 points, p = 0.002) and non-significant improvements on 10-metre walk test (+0.14 m/s, p = 0.093) and Timed Up and Go Test (-5.4 seconds, p = 0.087), compared with delayed provision.
  
  
  CONCLUSIONS
  We found positive effects of providing ankle-foot orthoses in (sub)acute stroke subjects that had not used these orthoses before.
authors.affiliation: 1 Roessingh Research and Development, Enschede, The Netherlands.|2 Department of Biomechanical Engineering, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands.
authors.forename: Corien Dm
authors.initials: CD
authors.lastname: Nikamp
authors.affiliation: 1 Roessingh Research and Development, Enschede, The Netherlands.|3 Department of Biomedical Signals and Systems, University of Twente, Enschede, The Netherlands.
authors.forename: Jaap H
authors.initials: JH
authors.lastname: Buurke
authors.affiliation: 4 Medisch Spectrum Twente, Medical School Twente, Enschede, The Netherlands.|5 Department of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, The Netherlands.
authors.forename: Job
authors.initials: J
authors.lastname: van der Palen
authors.affiliation: 1 Roessingh Research and Development, Enschede, The Netherlands.|3 Department of Biomedical Signals and Systems, University of Twente, Enschede, The Netherlands.
authors.forename: Hermie J
authors.initials: HJ
authors.lastname: Hermens
authors.affiliation: 1 Roessingh Research and Development, Enschede, The Netherlands.|2 Department of Biomechanical Engineering, MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands.|6 Department of Amputation and Orthopaedics, Roessingh Centre for Rehabilitation, Enschede, The Netherlands.
authors.forename: Johan S
authors.initials: JS
authors.lastname: Rietman
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000843:Ankle Joint; D002908:Chronic Disease; D004434:Early Ambulation / Q000295:instrumentation* / Q000379:methods; D005260:Female; D061826:Foot Orthoses / Q000600:supply & distribution*; D020233:Gait Disorders, Neurologic / Q000209:etiology / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011788:Quality of Life; D012047:Rehabilitation Centers; D012720:Severity of Illness Index; D020521:Stroke / Q000150:complications / Q000175:diagnosis*; D000071939:Stroke Rehabilitation / Q000295:instrumentation* / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D000070857:Walk Test / Q000379:methods
keywords: Ankle-foot orthosis; functional outcome; randomized controlled trial; stroke rehabilitation; timing of provision