The Effects of Spasticity on Glucose Metabolism in Individuals With Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Spasticity on Glucose Metabolism and Soft Tissue Body Composition in Individuals With Motor Complete and Motor Incomplete Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Diagnostic Test: body composition
* Diagnostic Test: glucose, insulin, glycohemoglobin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: body composition|fat mass % (FM%) and fat-free mass (FFM%)% of arms, legs, trunk, android, gynoid and total body|
|Diagnostic Test: glucose, 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body composition, glucose, spasticity, spinal cord injury