Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: a secondary analysis from a double-blind placebo-controlled randomized clinical trial

J Rehabil Med. 2010 Jan;42(1):81-9. doi: 10.2340/16501977-0474.

Abstract

Objective: To examine goal attainment scaling for evaluation of treatment for upper limb post-stroke spasticity with botulinum toxin-A.

Design: Secondary analysis of a multi-centre double-blind, placebo-controlled randomized clinical trial.

Setting: Six outpatient clinics in Australia.

Participants: Patients (n=90) completing per protocol 2 cycles of treatment/placebo. Mean age 54.5 (standard deviation 13.2) years. Mean time since stroke 5.9 (standard deviation 10.5) years.

Interventions: Intramuscular botulinum toxin-A (Dysport 500-1000U) or placebo given at 0 and 12 weeks. Measurement points were baseline, 8 and 20 weeks.

Main outcome measures: Individualized goal attainment and its relationship with spasticity and other person-centred measures - pain, mood, quality of life and global benefit.

Results: A significant treatment effect was observed with respect to goal attainment (Mann-Whitney z=-2.33, p< or = 0.02). Goal-attainment scaling outcome T-scores were highly correlated with reduction in spasticity (rho=0.36, p=0.001) and global benefit (rho=0.45, p<0.001), but not with other outcome measures. Goal-attainment scaling T-scores were lower than expected (median 32.4, interquartile range 29.6-40.6). Goals related to passive tasks were more often achieved than those reflecting active function. Qualitative analysis of goals nevertheless demonstrated change over a wide area of patient experience.

Conclusion: Goal-attainment scaling provided a responsive measure for evaluating focal intervention for upper limb spasticity, identifying outcomes of importance to the individual/carers, not otherwise identifiable using standardized measures.

Trial registration: ClinicalTrials.gov NCT00216411.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Adult
  • Botulinum Toxins, Type A / administration & dosage
  • Botulinum Toxins, Type A / therapeutic use*
  • Double-Blind Method
  • Goals
  • Hemiplegia / rehabilitation
  • Humans
  • Injections, Intramuscular
  • Motor Activity / physiology
  • Movement / physiology
  • Muscle Spasticity / drug therapy*
  • Muscle Spasticity / psychology
  • Muscle Spasticity / rehabilitation
  • Neuromuscular Agents / administration & dosage
  • Neuromuscular Agents / therapeutic use*
  • Outcome Assessment, Health Care
  • Quality of Life
  • Stroke Rehabilitation
  • Treatment Outcome
  • Upper Extremity / physiopathology

Substances

  • Neuromuscular Agents
  • Botulinum Toxins, Type A

Associated data

  • ClinicalTrials.gov/NCT00216411