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| Name | Class |
|---|---|
| Bobath Memorial Hospital | OTHER |
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The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between two different injection sites, namely at the proximal portion of the gastrocnemius(GCM) versus at the midbelly of the GCM.
Previous studies have used the midbelly of a muscle as the position where the motor endplates are most densely located. The reasoning behind this method was based on the previous works that showed most bands of cholinesterase activity to be located in specific topographical patterns at the center of the muscle fiber. These results have been used as landmarks to place the injections. Current standard guidelines recommend that botulinum toxin be placed at the 4 quadrants of the midbelly portion of the gastrocnemius (GCM) muscle. However, recent cadaveric research studies on the distribution of the intramuscular endings of the GCM suggest that the highest branch density is found within the upper 20-30% length of the calf. Therefore, in accordance to the theory that effect of botulinum toxin are greatest at sites where the intramuscular endings are most dense, the location where these toxins should be placed would be at these proximal sites of the GCM rather than at the midbelly.
40 recruited patients will be allocated into either the intramuscular ending targeted (ie.upper portion of calf) or midbelly targeted group.
Each subject will undergo a total number of 4 assessments; prior to the injection and 2,4and 8 weeks post injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramuscular ending Targeting | Experimental | Botox 200 units placed at the upper 2/10-3/10 length of the GCM |
|
| Midbelly Targeting | Active Comparator | A total of 200 units will be placed at the four quadrants of the midbelly portion of the GCM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOTOX-A® | Drug | 200 units, single treatment only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline for EMG (electromyogram) activity | Surface EMG | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS) | Change from baseline at 8 weeks | |
| Change from baseline of Ankle Range of motion | Passive range of motion of the ankle at resting state with the use of goniometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Im, MD, PhD | Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine | Bucheon-si | Kyounggido | South Korea |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Change from baseline at 8 weeks |
| Change from baseline of gait speed with 10 meters walk test | Change from baseline at 8 weeks | Change from baseline at 8 weeks |
| Change from baseline of ABILOCO scale | Change from baseline at 8 weeks |
| Change from baseline of Disability Assessment Scale | Change from baseline at 8 weeks |
| Change from baseline of Functional Ambulation Category Scale | Change from baseline at 8 weeks |
| Change of baseline of Lindmark Modified Fugyl Meyer Scale | Change from baseline at 8 weeks |
| Change from baseline of Tardieu angle of ankle | Change from baseline at 8 weeks |
| Bobath Memorial Hospital | Sŏngnam | Kyoungido | South Korea |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 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 |