An observational study in Spinal Cord Injuries, sponsored by Fatih Sultan Mehmet Training and Research Hospital. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-04.
Sponsored by Fatih Sultan Mehmet Training and Research Hospital · Observational
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.
703 studies on the registry are indexed under Muscle Spasticity; 148 are open to participants now.
This study's enrollment of 33 is below the median of 60 across 162 observational studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Fatih Sultan Mehmet Training and Research Hospital is the lead sponsor of 118 studies on the registry; 34 are open to participants now.
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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.
Exclusion Criteria:
fat mass % (FM%) and fat-free mass (FFM%)% of arms, legs, trunk, android, gynoid and total body
Also known as: dual-energy absorptiometry (DXA),
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.
Also known as: fasting blood glucose, insulin, glycohemoglobin
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: One day
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.
| Milestone | Motor Complete Group | Motor Incomplete Group |
|---|---|---|
| Started | 14 | 19 |
| Completed | 14 | 19 |
| Not completed | 0 | 0 |
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).
| correlation coefficient | Motor Complete | Motor Incomplete |
|---|---|---|
| Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance | -0.692 | 0.23 |
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).
| correlation coefficient | Motor Complete | Motor Incomplete |
|---|---|---|
| Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity | 0.797 | -0.084 |
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).
| correlation coefficient | Motor Complete Group | Motor Incomplete Group |
|---|---|---|
| Correlation Between Penn Spasm Frequency Scale and Insulin Resistance | 0.354 | -0.002 |
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).
| correlation coefficient | Motor Complete | Motor Incomplete |
|---|---|---|
| Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity | 0.289 | -0.103 |
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.
| correlation coefficient | Motor Complete | Motor Incomplete |
|---|---|---|
| Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass% | 0.201 | 0.287 |
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).
| correlation coefficient | Motor Complete | Motor Incomplete |
|---|---|---|
| Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass% | -0.138 | 0.526 |
Collected over One day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Motor Complete | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Motor Incomplete | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
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.
| Age, Categorical(Participants) | Motor Complete Group | Motor Incomplete Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 19 | 33 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Motor Complete Group | Motor Incomplete Group | Total |
|---|---|---|---|
| Female | 7 | 4 | 11 |
| Male | 7 | 15 | 22 |
| Race (NIH/OMB)(Participants) | Motor Complete Group | Motor Incomplete Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 14 | 19 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Motor Complete Group | Motor Incomplete Group | Total |
|---|---|---|---|
| Turkey | 14 | 19 | 33 |
| Time since injury(months) | Motor Complete Group | Motor Incomplete Group | Total |
|---|---|---|---|
| Mean | 47.4 ± 52.6 | 62.1 ± 47.8 | 55.85 ± 49.63 |
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Fatih Sultan Mehmet Training and Research Hospital