Muscle Spasticity
Conditions
Keywords
botulinum toxin, spasticity, injection technique, neuronox, meditoxin
Brief summary
Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.
Detailed description
This study is A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.
Interventions
DRUGUltrasonography guidance injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.
DRUGElectrical stimulation guidance injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.
DRUGManual needle placement injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subject aged over 20. 2. Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke. 3. Subjects who was diagnosed stroke at least 1 month prior to study participation. 4. Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.
Exclusion criteria
1. Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment. 2. Subjects with allergy or hypersensitivity to the Botulinum Toxin. 3. Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation. 4. Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation. 5. Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis). 6. Subjects who have been injected with botulinum toxin within past 3 months before the injection. 7. Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period. 8. Subjects who are scheduled to take part in other clinical trial during the study period. 9. Patients who are not eligible for this study at the medical discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms. | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms. | 4 weeks |
| Comparison evaluation on improvement rate of range of motion on each joint between 3 arms. | 4 weeks |
Outcome results
None listed