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

Phase 3

Recruiting

• Conditions: Stroke
• Interventions: Drug: OnabotulinumtoxinA

• Registration Number: NCT02580838
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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.

Study Timeline

• Study Start: 2015-08
• Status Verified: 2015-10
• Study First Submitted: 2015-10-11
• Study First Submitted QC: 2015-10-18
• Study First Posted: 2015-10-20
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30
• Primary Completion: 2023-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• stroke affecting one body side
• spasticity develops after stroke

Exclusion Criteria

• musculoskeletal conditions that affected upper limb function prior to stroke
• concurrent use of anti-spasticity medications
• patients with neuromuscular junction or myopathic disorders such as myasthenia gravis or others
• patients with a known allergy to any onabotulinumtoxinA or to any of the excipients of onabotulinumtoxinA (such as human serum albumin)
• patients who are pregnant or may become pregnant at the time of the proposed injection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early OnabotulinumtoxinA group	OnabotulinumtoxinA	OnabotulinumtoxinA will be injected immediately when spasticity develop in early OnabotulinumtoxinA group.
late OnabotulinumtoxinA group	OnabotulinumtoxinA	OnabotulinumtoxinA will be injected at 6 months after emergence of spasticity in late OnabotulinumtoxinA group.

Primary Outcome Measures

Name	Time	Method
Modified Ashworth Scale	change from baseline Modified Ashworth Scale at 4 weeks

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan