The Effects of Early and Late Injection of Botulinum Toxin Type A on Upper Limb Function in Patients With Stroke

Recruiting

Phase 3 Results N/A

Trial Description

The aim of this study is to determine whether early use of OnabotulinumtoxinA is more effective to improve functional outcomes of upper limb in patients with stroke.

Detailed Description

Many patients surviving stroke have significant impairment of function in the affected upper limb due to the development of spasticity. Botulinum toxin type A injection is a powerful treatment option for control of spasticity. In this study, the patients will be randomly assigned into three groups: early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention. The aim of this randomized controlled study is to evaluate the effects of early and late injection of botulinum toxin type A on upper limb function in patients with stroke.

Conditions

Interventions

  • OnabotulinumtoxinA Drug
    Intervention Desc: Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.
    ARM 1: Kind: Experimental
    Label: early OnabotulinumtoxinA group
    Description: OnabotulinumtoxinA will be injected immediately when spasticity develop in early OnabotulinumtoxinA group.
    ARM 2: Kind: Experimental
    Label: late OnabotulinumtoxinA group
    Description: OnabotulinumtoxinA will be injected at 6 months after emergence of spasticity in late OnabotulinumtoxinA group.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Ashworth Scale change from baseline Modified Ashworth Scale at 4 weeks Yes

Sponsors