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The aim of the study is to compare the effectiveness of the classical (2-4 points to the muscle proximal) application of botulinum toxin in the treatment of spasticity with the application along the length of the gastrecnemius muscle.
The main question it aims to answer Is botulinum toxin more effective in the treatment of spasticity than the classical application applied along the length of the gastrocnemius muscle? Participants will be evaluated for spasticity before and 1 month after injection.
Researchers will compare classical versus application along the length of the muscle to see if there is a reduction in spasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classic injection | Active Comparator | 200iu/2ml OnabotulinumtoxinA in total to 2-4 points proximal to the gastrocnemius muscle |
|
| İnjection along the length of the muscle | Experimental | A total of 200iu/2ml of onabotulinumtoxinA by spreading along the length of the gastrocnemius muscle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onabotulinumtoxina for Injection | Drug | 200iu/2ml in both groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spasticity assessment (change between pre-injection and 1-month control) | Modified ashworth scale | before injection and 1 month after injection |
| Spasticity assessment (change between pre-injection and 1-month control) | Tardieu scale | before injection and 1 month after injection |
| Spasticity assessment (change between pre-injection and 1-month control) | Joint range of motion measurement | before injection and 1 month after injection |
| ambulation level (change between pre-injection and 1-month control) | functional ambulation scale | before injection and 1 month after injection |
| ambulation velocity (change between pre-injection and 1-month control) | preferred walking speed | before injection and 1 month after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SavaÅŸ Karpuz, M.D. | Contact | +905552057860 | svskrpz@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| SavaÅŸ Karpuz | Konya Beyhekim Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konya Beyhekim Research and Training Hospital | Konya | Selçuklu | 42060 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16141745 | Background | Kim MW, Kim JH, Yang YJ, Ko YJ. Anatomic localization of motor points in gastrocnemius and soleus muscles. Am J Phys Med Rehabil. 2005 Sep;84(9):680-3. doi: 10.1097/01.phm.0000176341.85398.a9. | |
| 17049615 | Background | Prodanov D, Nagelkerke N, Marani E. Spatial clustering analysis in neuroanatomy: applications of different approaches to motor nerve fiber distribution. J Neurosci Methods. 2007 Feb 15;160(1):93-108. doi: 10.1016/j.jneumeth.2006.08.017. Epub 2006 Oct 17. |
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Shared if requested.
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| ID | Term |
|---|---|
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 8355728 | Background | Shaari CM, Sanders I. Quantifying how location and dose of botulinum toxin injections affect muscle paralysis. Muscle Nerve. 1993 Sep;16(9):964-9. doi: 10.1002/mus.880160913. |
| 15948200 | Background | Prodanov D, Thil MA, Marani E, Delbeke J, Holsheimer J. Three-dimensional topography of the motor endplates of the rat gastrocnemius muscle. Muscle Nerve. 2005 Sep;32(3):292-302. doi: 10.1002/mus.20378. |
| 9572248 | Background | Childers MK, Kornegay JN, Aoki R, Otaviani L, Bogan DJ, Petroski G. Evaluating motor end-plate-targeted injections of botulinum toxin type A in a canine model. Muscle Nerve. 1998 May;21(5):653-5. doi: 10.1002/(sici)1097-4598(199805)21:53.0.co;2-w. |
| 28382814 | Background | Kaymak B, Kara M, Tok F, Ulasli AM, Ozturk GT, Chang KV, Hsiao MY, Hung CY, Yagiz On A, Ozcakar L. Sonographic guide for botulinum toxin injections of the lower limb: EUROMUSCULUS/USPRM spasticity approach. Eur J Phys Rehabil Med. 2018 Jun;54(3):486-498. doi: 10.23736/S1973-9087.17.04667-6. Epub 2017 Apr 4. |
| 39343047 | Derived | Karpuz S, Yilmaz R, Yilmaz H. Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-Blind Controlled Study. Arch Phys Med Rehabil. 2025 Mar;106(3):327-332. doi: 10.1016/j.apmr.2024.09.011. Epub 2024 Sep 27. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |