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Determination of which muscle is more spastic before injection of the botulinum toxin, and the application of the targeted treatment to that muscle results in more improvement in spasticity. It is known that the muscles that flex elbow in healthy individuals change according to forearm position. While the biceps brachii flexes the forearm in supination, the brachioradialis flexes the forearm in the neutral position. The brachialis muscle acts as a primary flexor muscle when the forearm is in pronation.
In this study, hypothesis is that the severity of spasticity differs depending on the forearm position.
There are three main muscles that contribute to elbow flexor spasticity; musculus biceps brachii, musculus brachialis and musculus brachioradialis. Muscle selection in elbow flexor spasticity for botulinum toxin application has impact on treatment outcome. The superficiality of the biceps brachii muscle makes it an easy target for botulinum toxin injection. In dynamic electromyography studies, it has been reported that brachioradialis muscle is the most common contributor one to elbow flexion spasticity, followed by biceps brachii muscle. In the diagnostic selective nerve blocks, the brachialis muscle has been reported to be foreground.
Determination of which muscle is more spastic before injection of the botulinum toxin, and the application of the targeted treatment to that muscle results in more improvement in spasticity. Can the target muscle selection clinically be performed instead of methods such as electromyography where equipment is required and the evaluation period is relatively long? Can semi-quantitative methods used to assess the severity of spasticity provide reliable information regarding the muscle or muscles that contribute to elbow flexor spasticity? It is known that the muscles that flex elbow in healthy individuals change according to forearm position. While the biceps brachii flexes the forearm in supination, the brachioradialis flexes the forearm in the neutral position. The brachialis muscle acts as a primary flexor muscle when the forearm is in pronation.
The aim of this study is to investigate whether the severity of spasticity differs depending on the forearm position.
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| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Component of Spasticity (Spasticity Angle) | According to the Modified Tardieu Scale, the difference between the angle of slow passive motion and the angle of muscle reaction represents the dynamic component of spasticity (spasticity angle) in degree. A big difference suggests spasticity while the low difference suggests muscular contracture. In this study, dynamic component of spasticity (spasticity angle) at forearm pronation, neutral position and supination was evaluated separately. | 1 day (Only one measurement was performed in time (cross-sectional)) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with post-stroke elbow flexor spasticity
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| Name | Affiliation | Role |
|---|---|---|
| ilker şengül | İzmir Katip Çelebi University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ilker Şengül | Izmir | In the USA Or Canada, Please Select... | 35360 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3042230 | Background | Keenan MA. Management of the spastic upper extremity in the neurologically impaired adult. Clin Orthop Relat Res. 1988 Aug;(233):116-25. | |
| 27595994 | Background | Genet F, Schnitzler A, Droz-Bartholet F, Salga M, Tatu L, Debaud C, Denormandie P, Parratte B. Successive motor nerve blocks to identify the muscles causing a spasticity pattern: example of the arm flexion pattern. J Anat. 2017 Jan;230(1):106-116. doi: 10.1111/joa.12538. Epub 2016 Sep 6. |
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This study enrolled patients with post-stroke elbow flexor spasticity from a single medical center in Turkey. The last patients completed in July 2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Post-stroke Elbow Flexor Spasticity | Participants with post-stroke elbow flexor spasticity |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Post-stroke Elbow Flexor Spasticity | Participants with post-stroke elbow flexor spasticity |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dynamic Component of Spasticity (Spasticity Angle) | According to the Modified Tardieu Scale, the difference between the angle of slow passive motion and the angle of muscle reaction represents the dynamic component of spasticity (spasticity angle) in degree. A big difference suggests spasticity while the low difference suggests muscular contracture. In this study, dynamic component of spasticity (spasticity angle) at forearm pronation, neutral position and supination was evaluated separately. | Posted | Median | Inter-Quartile Range | degree | 1 day (Only one measurement was performed in time (cross-sectional)) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Post-stroke Elbow Flexor Spasticity | Participants with post-stroke elbow flexor spasticity |
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Technical problems related to measurement in determining muscle reaction angle and slow controlled motion with a standard goniometer. The use of semi-quantitative spasticity assessment scales.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ilker şengül | İzmir Katip Çelebi University, Faculty of Medicine | 05337333698 | ilkrsngl@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2018 | Feb 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 2380525 | Background | Keenan MA, Haider TT, Stone LR. Dynamic electromyography to assess elbow spasticity. J Hand Surg Am. 1990 Jul;15(4):607-14. doi: 10.1016/s0363-5023(09)90023-5. |
| 13475410 | Background | BASMAJIAN JV, LATIF A. Integrated actions and functions of the chief flexors of the elbow: a detailed electromyographic analysis. J Bone Joint Surg Am. 1957 Oct;39-A(5):1106-18. No abstract available. |
| 3809245 | Background | Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206. |
| 20927007 | Background | Gracies JM, Bayle N, Vinti M, Alkandari S, Vu P, Loche CM, Colas C. Five-step clinical assessment in spastic paresis. Eur J Phys Rehabil Med. 2010 Sep;46(3):411-21. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of stroke | Count of Participants | Participants |
|
| Side of plegia | Count of Participants | Participants |
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| Disease duration | Median | Inter-Quartile Range | months |
|
| Brunnstrom stage of motor recovery of upper extremity | The Brunnstrom recovery stages approach contains 3 subgroups (arm, hand and limb) which are scored separately on a 7-level likert scale (level I to VII).The stage I represents flaccid paralysis. Stage II marks the development of some synergy patterns. Spasticity reaches its peak in stage III. Spasticity begins to decrease in stage IV and patients have some normal movement patterns. In stage V, spasticity continues to decrease, and voluntary movements are more coordinated. In stage VI, motor control of the affected extremity is almost complete. Stage VII represents the return of full function. | Median | Inter-Quartile Range | units on a scale |
|
| Brunnstrom stage of motor recovery of hand | The Brunnstrom recovery stages approach contains 3 subgroups (arm, hand and limb) which are scored separately on a 7-level likert scale (level I to VII).The stage I represents flaccid paralysis. Stage II marks the development of some synergy patterns. Spasticity reaches its peak in stage III. Spasticity begins to decrease in stage IV and patients have some normal movement patterns. In stage V, spasticity continues to decrease, and voluntary movements are more coordinated. In stage VI, motor control of the affected extremity is almost complete. Stage VII represents the return of full function. | Mean | Inter-Quartile Range | units on a scale |
|
| Brunnstrom stage of motor recovery of lower extremity | The Brunnstrom recovery stages approach contains 3 subgroups (arm, hand and limb) which are scored separately on a 7-level likert scale (level I to VII).The stage I represents flaccid paralysis. Stage II marks the development of some synergy patterns. Spasticity reaches its peak in stage III. Spasticity begins to decrease in stage IV and patients have some normal movement patterns. In stage V, spasticity continues to decrease, and voluntary movements are more coordinated. In stage VI, motor control of the affected extremity is almost complete. Stage VII represents the return of full function. | Median | Inter-Quartile Range | units on a scale |
|
| Severity of spasticity according to the Modified Ashworth Scale in forearm pronation | The Modified Ashworth Scale indicates presence and severity of muscle spasticity. The Modified Ashworth Scale has 6 stages ranging between 0 to 4 (0, 1, 1+, 2, 3, 4). The severity of spasticity increases as the score increases. Score 0 represents no increase in tone, and in score 4, affected part is rigid. In statistical analysis, 6 stages ranging between 0 to 5 (0, 1, 2, 3, 4, 5) was used. Score of 1+ was treated as 2, 2 was treated as 3, 3 was treated as 4, and 4 was treated as 5. | Median | Inter-Quartile Range | units on a scale |
|
| Severity of spasticity according to the Modified Ashworth Scale in the neutral position of forearm | The Modified Ashworth Scale indicates presence and severity of muscle spasticity. The Modified Ashworth Scale has 6 stages ranging between 0 to 4 (0, 1, 1+, 2, 3, 4). The severity of spasticity increases as the score increases. Score 0 represents no increase in tone, and in score 4, affected part is rigid. In statistical analysis, 6 stages ranging between 0 to 5 (0, 1, 2, 3, 4, 5) was used. Score of 1+ was treated as 2, 2 was treated as 3, 3 was treated as 4, and 4 was treated as 5. | Median | Inter-Quartile Range | units on a scale |
|
| Severity of spasticity according to the Modified Ashworth Scale in forearm supination | The Modified Ashworth Scale indicates presence and severity of muscle spasticity. The Modified Ashworth Scale has 6 stages ranging between 0 to 4 (0, 1, 1+, 2, 3, 4). The severity of spasticity increases as the score increases. Score 0 represents no increase in tone, and in score 4, affected part is rigid. In statistical analysis, 6 stages ranging between 0 to 5 (0, 1, 2, 3, 4, 5) was used. Score of 1+ was treated as 2, 2 was treated as 3, 3 was treated as 4, and 4 was treated as 5. | Median | Inter-Quartile Range | units on a scale |
|
| Spontaneous elbow angle | Mean | Standard Deviation | degree |
|
| Slow controlled motion (passive range of motion) of elbow joint in pronation | Median | Inter-Quartile Range | degree |
|
| Slow controlled motion (passive range of motion) of elbow joint in the neutral position of forearm | Median | Inter-Quartile Range | degree |
|
| Slow controlled motion (passive range of motion) of elbow joint in supination | Median | Inter-Quartile Range | degree |
|
| Angle of muscle reaction in pronation | Median | Inter-Quartile Range | degree |
|
| Angle of muscle reaction in the neutral position | Median | Inter-Quartile Range | degree |
|
| Angle of muscle reaction in supination | Median | Inter-Quartile Range | degree |
|
| Quality of muscle reaction in pronation | To grade the quality of muscle reaction according to the Modified Tardieu Scale, passive stretch is performed by taking into account the falling speed of the limb segment under gravity .The quality of muscle reaction ranges from 0 to 4. Grade 0 represents no spasticity and grade 4 represents severe spasticity. Grade 1 means slight resistance to passive stretch with no clear catch at precise angle. Grade 2 marks clear catch at precise angle followed by release. Grade 3 represents fatigable clonus occurring at precise angle, and grade 4 represents nonfatigable clonus occurring at precise angle. | Median | Inter-Quartile Range | units on a scale |
|
| Quality of muscle reaction in the neutral position of forearm | To grade the quality of muscle reaction according to the Modified Tardieu Scale, passive stretch is performed by taking into account the falling speed of the limb segment under gravity .The quality of muscle reaction ranges from 0 to 4. Grade 0 represents no spasticity and grade 4 represents severe spasticity. Grade 1 means slight resistance to passive stretch with no clear catch at precise angle. Grade 2 marks clear catch at precise angle followed by release. Grade 3 represents fatigable clonus occurring at precise angle, and grade 4 represents nonfatigable clonus occurring at precise angle. | Median | Inter-Quartile Range | units on a scale |
|
| Quality of muscle reaction in supination | To grade the quality of muscle reaction according to the Modified Tardieu Scale, passive stretch is performed by taking into account the falling speed of the limb segment under gravity .The quality of muscle reaction ranges from 0 to 4. Grade 0 represents no spasticity and grade 4 represents severe spasticity. Grade 1 means slight resistance to passive stretch with no clear catch at precise angle. Grade 2 marks clear catch at precise angle followed by release. Grade 3 represents fatigable clonus occurring at precise angle, and grade 4 represents nonfatigable clonus occurring at precise angle. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 |
| Spasticity Angle in Neutral Position |
Second group of three groups of paired observations consisting of participants whose measurements of dynamic component of elbow flexor spasticity were performed in the neutral position of forearm |
| OG002 | Spasticity Angle in Supination | Third group of three groups of paired observations consisting of participants whose measurements of dynamic component of elbow flexor spasticity were performed in the supination position of forearm |
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| 0 |
| 60 |
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| 60 |
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| 60 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |