Effects of Botulinum Toxin on Upper Limb Function in Stroke Patients
The Effects of Early and Late Injection of Botulinum Toxin Type A on Upper Limb Function in Patients With Stroke
This study tests whether getting Botox injections sooner or later can help stroke patients with stiff arms move better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Locations | 1 site (Tainan) |
| Trial ID | NCT02580838 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of early versus late injections of OnabotulinumtoxinA in improving upper limb function in stroke patients experiencing spasticity. Participants will be randomly assigned to one of three groups: those receiving early injections when spasticity develops, those receiving injections six months later, and a control group with no injections. The study will assess functional outcomes to determine the optimal timing for intervention. By comparing these groups, the research seeks to provide insights into the best practices for managing spasticity post-stroke.
Who should consider this trial
Good fit: Ideal candidates are stroke survivors with spasticity affecting one side of their body.
Not a fit: Patients with pre-existing musculoskeletal conditions affecting upper limb function or those with certain neuromuscular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for stroke patients, enhancing their upper limb function and overall quality of life.
How similar studies have performed: Previous studies have shown promising results with botulinum toxin for spasticity management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tainan
- Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Richard Lin — Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital
- Study coordinator: Richard Lin
- Email: richelin@mail.ncku.edu.tw
- Phone: 886-6-2353535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.