Effects on Quality of Life Following Dysport Treatment in Post-Stroke Spasticity of the Arm

Completed

Phase 4 Results N/A

Trial Description

The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).
Secondary Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)
Secondary Change in the Modified Motor Assessment Scale
Secondary Change in patient disability and carer burden rating scale total score
Secondary Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)
Secondary Change in the degree of pain
Secondary Change in depression rating scale total score
Secondary Global assessment of benefit

Sponsors