Spinal Cord Injuries
Conditions
Keywords
Body composition, glucose, spasticity, spinal cord injury
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTbody composition
fat mass % (FM%) and fat-free mass (FFM%)% of arms, legs, trunk, android, gynoid and total body
DIAGNOSTIC_TESTglucose, insulin, glycohemoglobin
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.
Sponsors
Fatih Sultan Mehmet Training and Research Hospital
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Spinal cord injury AIS A,B,C,D
Exclusion criteria
* Other central nervous system diseases * Significant complications that affect spasticity * Joint contracture * Diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance | One day | 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 Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity | One day | 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 Between Penn Spasm Frequency Scale and Insulin Resistance | One day | 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 Between Penn Spasm Frequency Scale and Insulin Sensitivity | One day | 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 Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass% | One day | 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 Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass% | One day | 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). |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Motor Complete Group Individuals with American Spinal Injury Association Impairment Scale (AIS) grades A and B. | 14 |
| Motor Incomplete Group Individuals with American Spinal Injury Association Impairment Scale (AIS) grades C and D. | 19 |
| Total | 33 |
Baseline characteristics
| Characteristic | Motor Complete Group | Motor Incomplete Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 19 Participants | 33 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 19 Participants | 33 Participants |
| Region of Enrollment Turkey | 14 Participants | 19 Participants | 33 Participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 15 Participants | 22 Participants |
| Time since injury | 47.4 months STANDARD_DEVIATION 52.6 | 62.1 months STANDARD_DEVIATION 47.8 | 55.85 months STANDARD_DEVIATION 49.63 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 19 |
| other Total, other adverse events | 0 / 14 | 0 / 19 |
| serious Total, serious adverse events | 0 / 14 | 0 / 19 |
Outcome results
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).
Time frame: One day
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motor Complete | Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance | -0.692 correlation coefficient |
| Motor Incomplete | Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance | 0.23 correlation coefficient |
p-value: 0.006Pearson correlation test
p-value: 0.23Pearson correlation test
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).
Time frame: One day
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motor Complete | Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity | 0.797 correlation coefficient |
| Motor Incomplete | Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity | -0.084 correlation coefficient |
p-value: 0.001Pearson correlation test
p-value: 0.731Pearson correlation test
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.
Time frame: One day
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motor Complete | Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass% | 0.201 correlation coefficient |
| Motor Incomplete | Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass% | 0.287 correlation coefficient |
p-value: 0.511Pearson correlation test
p-value: 0.248Pearson correlation test
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).
Time frame: One day
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motor Complete | Correlation Between Penn Spasm Frequency Scale and Insulin Resistance | 0.354 correlation coefficient |
| Motor Incomplete | Correlation Between Penn Spasm Frequency Scale and Insulin Resistance | -0.002 correlation coefficient |
p-value: 0.214Pearson correlation test
p-value: 0.993Pearson correlation test
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).
Time frame: One day
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motor Complete | Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity | 0.289 correlation coefficient |
| Motor Incomplete | Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity | -0.103 correlation coefficient |
p-value: 0.41Pearson correlation test
p-value: 0.676Pearson correlation test
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).
Time frame: One day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motor Complete | Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass% | -0.138 correlation coefficient |
| Motor Incomplete | Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass% | 0.526 correlation coefficient |
p-value: 0.654Pearson correlation test
p-value: 0.025Pearson correlation test