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Muscle atrophy may occur in individuals with spinal cord injury (SCI) as a result of diminished physical activity and alterations in glucose metabolism and body composition may be seen. In a few studies, it has been suggested that spasticity may have a positive impact on glucose metabolism by preventing muscle atrophy and alterations in body composition in individuals with motor complete SCI. Investigators aimed to assess the effects of spasticity on glucose metabolism and body composition in participants with complete and incomplete SCI.
Investigators plan a prospective clinical trial. Participants with SCI were included to study if times from injury were at least one year. Participants had an AIS grades of A-D with spasticity. We evaluated that participants with AIS A and B SCI were motor complete group, AIS C and D SCI were motor incomplete group. Spasticity was assessed with Modified Ashworth Scale (MAS) and spasms were assessed with Penn Spasm Frequency Scale (PSFS). Hip adductor and extensor spasticity, knee extensor and flexor spasticity and ankle plantar flexor spasticity were assessed by using MAS. Body composition was measured by dual-energy x-ray absorptiometry. All participants underwent a 75 gram (g) oral glucose tolerance test (OGTT). Insulin sensitivity was assessed by calculating Matsuda index and HOMA-IR. Investigators assessed the effects of spasticity on glucose metabolism and body composition in participants with SCI.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| body composition | Diagnostic Test | fat mass % (FM%) and fat-free mass (FFM%)% of arms, legs, trunk, android, gynoid and total body |
| |
| glucose, insulin, glycohemoglobin | Diagnostic Test | In the morning after 12 hours overnight fast, all individuals underwent a 75 gram (g) oral glucose tolerance test (OGTT). Blood samples were taken before loading glucose and then 30, 60, 90 and 120 minutes after taking glucose solution in order to measure serum glucose and insulin levels. Glycohemoglobin (HbA1c) was measured in blood samples taken before the OGTT. We calculated the Matsuda index and Homeostasis model assessment index (HOMA-IR) using glucose and insulin levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance | Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. HOMA index was used to evaluate insulin resistance. HOMA index is a simple, and inexpensive method used for evaluating insulin sensitivity. In most of the studies, values >2.7 were accepted as insulin resistance. HOMA-IR was calculated by using fasting plasma glucose (mg/dL) X fasting insulin (uIU/mL) /405 formula. Pearson correlation was used to calculate the correlation coefficient (r). | One day |
| Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity | We used the Matsuda index to assess insulin sensitivity. Matsuda index was calculated 10.000/square root (Fasting plasma glucose x fasting plasma insulin) x (mean OGTT glucose concentration X mean OGTT insulin concentration) formula. Higher scores mean better. Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r). | One day |
| Correlation Between Penn Spasm Frequency Scale and Insulin Resistance | Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. HOMA index is a simple, and inexpensive method used for evaluating insulin sensitivity. In most of the studies, values >2.7 were accepted as insulin resistance. HOMA-IR was calculated by using fasting plasma glucose (mg/dL) X fasting insulin (uIU/mL) /405 formula. Pearson correlation was used to calculate the correlation coefficient (r). | One day |
| Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity | We used the Matsuda index to assess insulin sensitivity. Matsuda index was calculated 10.000/square root (Fasting plasma glucose x fasting plasma insulin) x (mean OGTT glucose concentration X mean OGTT insulin concentration) formula. Higher scores mean better. Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r). |
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Inclusion Criteria:
• Spinal cord injury AIS A,B,C,D
Exclusion Criteria:
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Individuals with SCI were included to study if they were 18-65 years old and times from injury were at least one year.
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| Name | Affiliation | Role |
|---|---|---|
| Arzu Atici | Fatih Sultan Mehmet Training and Research Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10597805 | Background | Skold C, Levi R, Seiger A. Spasticity after traumatic spinal cord injury: nature, severity, and location. Arch Phys Med Rehabil. 1999 Dec;80(12):1548-57. doi: 10.1016/s0003-9993(99)90329-5. | |
| 17637764 | Background | Gorgey AS, Dudley GA. Spasticity may defend skeletal muscle size and composition after incomplete spinal cord injury. Spinal Cord. 2008 Feb;46(2):96-102. doi: 10.1038/sj.sc.3102087. Epub 2007 Jul 17. |
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Individuals with SCI recruited from the inpatient rehabilitation unit of an education and research hospital. Recruitment began in September 2014 and was completed in May 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Motor Complete Group | Individuals with American Spinal Injury Association (ASIA) Impairment Scale grades A and B. |
| FG001 | Motor Incomplete Group | Individuals with American Spinal Injury Association (ASIA) Impairment Scale grades C and D. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ASIA impairment scale (AIS) is the most prominent standardized clinical grading and classification method for the assessment of patients with spinal cord injury (SCI). Patients with AIS A and B are motor complete group, AIS C and D are motor incomplete group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Motor Complete Group | Individuals with American Spinal Injury Association Impairment Scale (AIS) grades A and B. |
| BG001 | Motor Incomplete Group | Individuals with American Spinal Injury Association Impairment Scale (AIS) grades C and D. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance | Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. HOMA index was used to evaluate insulin resistance. HOMA index is a simple, and inexpensive method used for evaluating insulin sensitivity. In most of the studies, values >2.7 were accepted as insulin resistance. HOMA-IR was calculated by using fasting plasma glucose (mg/dL) X fasting insulin (uIU/mL) /405 formula. Pearson correlation was used to calculate the correlation coefficient (r). | Individuals with spinal cord injury AIS A and AIS B (motor complete) and AIS C and D (motor incomplete) were evaluated. These 2 groups were not compared to each other. Each 2 groups were evaluated separately. | Posted | Number | correlation coefficient | One day |
|
One day
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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 | Motor Complete | individuals with AIS A, B | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MD. Arzu Atici | Fatih Sultan Mehmet Education and Research Hospital | +905335621208 | arzususinatici@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 6, 2020 | Aug 7, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 6, 2020 | Aug 8, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 6, 2020 | Aug 19, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D001823 | Body Composition |
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D001824 | Body Constitution |
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| One day |
| Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass% | The body composition of the individuals was measured by dual-energy absorptiometry (DXA) device. Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. Pearson correlation was used to calculate correlation coefficient. | One day |
| Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass% | The body composition of the individuals was measured by dual-energy absorptiometry (DXA) device. Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r). | One day |
| 25001559 | Background | Gorgey AS, Dolbow DR, Dolbow JD, Khalil RK, Castillo C, Gater DR. Effects of spinal cord injury on body composition and metabolic profile - part I. J Spinal Cord Med. 2014 Nov;37(6):693-702. doi: 10.1179/2045772314Y.0000000245. Epub 2014 Jul 7. |
| 16940987 | Background | Gorgey AS, Dudley GA. Skeletal muscle atrophy and increased intramuscular fat after incomplete spinal cord injury. Spinal Cord. 2007 Apr;45(4):304-9. doi: 10.1038/sj.sc.3101968. Epub 2006 Aug 29. |
| 20397439 | Background | Gorgey AS, Chiodo AE, Zemper ED, Hornyak JE, Rodriguez GM, Gater DR. Relationship of spasticity to soft tissue body composition and the metabolic profile in persons with chronic motor complete spinal cord injury. J Spinal Cord Med. 2010;33(1):6-15. doi: 10.1080/10790268.2010.11689669. |
| 27618974 | Background | Jung IY, Kim HR, Chun SM, Leigh JH, Shin HI. Severe spasticity in lower extremities is associated with reduced adiposity and lower fasting plasma glucose level in persons with spinal cord injury. Spinal Cord. 2017 Apr;55(4):378-382. doi: 10.1038/sc.2016.132. Epub 2016 Sep 13. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Time since injury | Mean | Standard Deviation | months |
|
American Spinal Injury Association Impairment Scale (AIS) Grades of A, B |
| OG001 | Motor Incomplete | American Spinal Injury Association Impairment Scale (AIS) Grades of C, D |
|
|
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| Primary | Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity | We used the Matsuda index to assess insulin sensitivity. Matsuda index was calculated 10.000/square root (Fasting plasma glucose x fasting plasma insulin) x (mean OGTT glucose concentration X mean OGTT insulin concentration) formula. Higher scores mean better. Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r). | Individuals with spinal cord injury AIS A and AIS B (motor complete) and AIS C and D (motor incomplete) were evaluated. These 2 groups were not compared to each other. Each 2 groups were evaluated separately. | Posted | Number | correlation coefficient | One day |
|
|
|
|
| Primary | Correlation Between Penn Spasm Frequency Scale and Insulin Resistance | Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. HOMA index is a simple, and inexpensive method used for evaluating insulin sensitivity. In most of the studies, values >2.7 were accepted as insulin resistance. HOMA-IR was calculated by using fasting plasma glucose (mg/dL) X fasting insulin (uIU/mL) /405 formula. Pearson correlation was used to calculate the correlation coefficient (r). | Individuals with spinal cord injury AIS A and AIS B (motor complete) and AIS C and D (motor incomplete) were evaluated. These 2 groups were not compared to each other. Each 2 groups were evaluated separately. | Posted | Number | correlation coefficient | One day |
|
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|
|
| Primary | Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity | We used the Matsuda index to assess insulin sensitivity. Matsuda index was calculated 10.000/square root (Fasting plasma glucose x fasting plasma insulin) x (mean OGTT glucose concentration X mean OGTT insulin concentration) formula. Higher scores mean better. Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r). | Individuals with spinal cord injury AIS A and AIS B (motor complete) and AIS C and D (motor incomplete) were evaluated. These 2 groups were not compared to each other. Each 2 groups were evaluated separately. | Posted | Number | correlation coefficient | One day |
|
|
|
|
| Primary | Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass% | The body composition of the individuals was measured by dual-energy absorptiometry (DXA) device. Modified Ashworth Scale is used to assess muscle spasticity on a 6-point scale. 0: No increase in muscle tone 4: Affected part(s) is (are) rigid in flexion or extension. Higher scores mean a worse outcome. Pearson correlation was used to calculate correlation coefficient. | Individuals with spinal cord injury AIS A and AIS B (motor complete) and AIS C and D (motor incomplete) were evaluated. These 2 groups were not compared to each other. Each 2 groups were evaluated separately. | Posted | Number | correlation coefficient | One day |
|
|
|
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| Primary | Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass% | The body composition of the individuals was measured by dual-energy absorptiometry (DXA) device. Penn Spasm Frequency Scale is used to assess spasms. This scale is a 5-point scale. Higher scores mean a worse outcome. Pearson correlation was used to calculate the correlation coefficient (r). | Posted | Number | correlation coefficient | One day |
|
|
|
|
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Motor Incomplete | individuals with AIS C, D | 0 | 19 | 0 | 19 | 0 | 19 |
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| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010829 |
| Physiological Phenomena |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| Other |
| Other |
| Other |
| Other |
| Other |