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Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonography guidance | Experimental | Ultrasonography guidance injection of Meditoxin®. |
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| Electrical stimulation guidance | Experimental | Electrical stimulation guidance injection of Meditoxin®. |
|
| Manual needle placement | Experimental | Manual needle placement injection of Meditoxin®. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonography guidance injection of Meditoxin®. | Drug | Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms. | 4 weeks |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MyungEun Chung | St. Paul's Hospital, The Catholic University of Korea | Principal Investigator |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| Electrical stimulation guidance injection of Meditoxin®. | Drug | Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance. |
|
| Manual needle placement injection of Meditoxin®. | Drug | Meditoxin® will be injected to upper limb spasticity by using the manual needle placement. |
|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |