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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02580838

Enrollment

150

Registered

2015-10-20

Start date

2015-08-31

Completion date

2025-09-30

Last updated

2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Spasticity, OnabotulinumtoxinA

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.

Interventions

DRUGOnabotulinumtoxinA

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Modified Ashworth Scale	change from baseline Modified Ashworth Scale at 4 weeks

Countries

Taiwan

Contacts

Primary ContactRichard Lin

richelin@mail.ncku.edu.tw886-6-2353535

Backup ContactRichard Lin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026