title: An early botulinum toxin A treatment in subacute stroke patients may prevent a disabling finger flexor stiffness six months later: a randomized controlled trial.
abstract: OBJECTIVE
  The study asked whether an early botulinum toxin A (BTX-A) injection in subacute stroke patients may prevent a disabling finger flexor stiffness six months later.
  
  
  METHODS
  Single-blind, randomized pilot study.
  
  
  METHODS
  Inpatient rehabilitation centre.
  
  
  METHODS
  Eighteen stroke patients, interval 4-6 weeks, non-functional arm, Fugl-Meyer arm score (0-66) <20, beginning elevated finger flexor tone, randomly allocated to group A or B.
  
  
  METHODS
  In group A patients 150 units BTX-A (Xeomin) injected into the deep and superficial finger (100 units) and wrist flexors (50 units), no injection in group B patients. Comprehensive rehabilitation in both groups.
  
  
  METHODS
  Primary variable was the Modified Ashworth Scale score (0-5) of the finger flexors; secondary variables were whole arm muscle tone with REPAS (a summary rating scale for resistance to passive movement), its motor control with the Fugl-Meyer arm score, and a disability scale, blindly assessed at T0 (start), T1 (four weeks) and T6 (six months).
  
  
  RESULTS
  Homogeneous groups at T0. Significantly less finger flexor stiffness in the BTX-A group at T1 and T6, the mean (SD) Modified Ashworth Scale scores in group A (B) were: 1.7 ± 0.5 (1.6 ± 0.5) at T0; 0.4 ± 0.5 (1.9 ± 0.7) at T1; and 1.4 ± 0.7 (2.4 ± 0.9) at T6. Among the secondary measures, the disability score, namely the items pain and passive nail trimming, was lower in group A at T1 and T6.
  
  
  CONCLUSIONS
  The results indicate an effect of early BTX-A injection on finger flexor stiffness six months later, presumably attributable to a reduced contracture development. Effect size calculation suggests inclusion of at least 17 patients per group excluding drop-outs in a warranted placebo-controlled trial.
authors.affiliation: Medical Park Berlin Humboldtmühle, Neurological Rehabilitation, Charité-University Medicine Berlin, Germany. s.hesse@medicalpark.de
authors.forename: S
authors.initials: S
authors.lastname: Hesse
authors.forename: H
authors.initials: H
authors.lastname: Mach
authors.forename: S
authors.initials: S
authors.lastname: Fröhlich
authors.forename: S
authors.initials: S
authors.lastname: Behrend
authors.forename: C
authors.initials: C
authors.lastname: Werner
authors.forename: I
authors.initials: I
authors.lastname: Melzer
mesh_terms: D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D016001:Confidence Intervals; D003286:Contracture / Q000209:etiology / Q000517:prevention & control*; D004185:Disability Evaluation; D004334:Drug Administration Schedule; D005260:Female; D005384:Finger Joint / Q000187:drug effects / Q000503:physiopathology; D005500:Follow-Up Studies; D005858:Germany; D006429:Hemiplegia / Q000188:drug therapy* / Q000209:etiology / Q000534:rehabilitation; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000517:prevention & control; D018482:Muscle, Skeletal / Q000187:drug effects* / Q000503:physiopathology; D010865:Pilot Projects; D012047:Rehabilitation Centers; D018570:Risk Assessment; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D020521:Stroke / Q000150:complications; D000071939:Stroke Rehabilitation; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D019274:Botulinum Toxins, Type A