title: Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life.
abstract: OBJECTIVE
  To evaluate the impact of intrathecal baclofen (ITB) on function and quality of life (QOL) and to obtain efficacy and safety data in poststroke spastic hypertonia.
  
  
  METHODS
  Prospective open-label multicenter trial with follow-up at 3 and 12 months.
  
  
  METHODS
  Twenty-four stroke treatment centers in the United States.
  
  
  METHODS
  Ninety-four stroke participants (age range, 24-82 y) with spastic hypertonia. Seventy-four participants underwent ITB pump implantation.
  
  
  METHODS
  Participants were implanted with an ITB pump.
  
  
  METHODS
  FIM instrument and QOL (Sickness Impact Profile [SIP]) changes, spastic hypertonia (Ashworth Scale), and safety.
  
  
  RESULTS
  FIM scores improved overall in repeated-measures analysis of variance (ANOVA) (P = .005) and by 3.00 +/- 7.69 (P = .001) at 3 months and by 2.86 +/- 10.13 (P = .017) at 12 months. Significant improvements in SIP scores were noted overall (repeated-measures ANOVA, P < .001) and at 3 (P = .003) and 12 months (P < .001). The combined average Ashworth Scale score of the upper and lower limbs decreased by 1.27 +/- 0.76 (P < .001) at 3 months and by 1.39 +/- 0.73 (P < .001) at 12 months from baseline, which was significant overall (repeated-measures ANOVA, P<.001). Strength in the unaffected side did not change overall (repeated-measures ANOVA, P = .321) or at either 3 (P = .553) or 12 months (P = .462). Minimal adverse events and device complications were reported.
  
  
  CONCLUSIONS
  There was significant improvement in function, QOL, and spastic hypertonia at 3 and 12 months after implant, without adversely affecting muscle strength of the unaffected limbs. Data suggest that ITB therapy is a safe and efficacious treatment for spastic hypertonia resulting from stroke.
authors.affiliation: Brain Injury and Stroke Program, The Institute for Rehabilitation and Research, Houston, TX 77030, USA. cindy.ivanhoe@memorialhermann.org
authors.forename: Cindy B
authors.initials: CB
authors.lastname: Ivanhoe
authors.forename: Gerard E
authors.initials: GE
authors.lastname: Francisco
authors.forename: John R
authors.initials: JR
authors.lastname: McGuire
authors.forename: Thyagarajan
authors.initials: T
authors.lastname: Subramanian
authors.forename: Samuel P
authors.initials: SP
authors.lastname: Grissom
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001418:Baclofen / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015918:Infusion Pumps, Implantable; D007278:Injections, Spinal; D008297:Male; D008875:Middle Aged; D009122:Muscle Hypertonia / Q000188:drug therapy* / Q000209:etiology*; D009125:Muscle Relaxants, Central / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D020521:Stroke / Q000150:complications*
chemical_list: D009125:Muscle Relaxants, Central; D001418:Baclofen