N/A
N=33
The Effects of Spasticity on Glucose Metabolism in Individuals With Spinal Cord Injury
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03859960 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance — -0.692; 0.23 correlation coefficient — p=0.006
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- body composition (Diagnostic_test); glucose, insulin, glycohemoglobin (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance |
-0.692; 0.23 | 0.006 sig |
| PRIMARY Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity |
0.797; -0.084 | 0.001 sig |
| PRIMARY Correlation Between Penn Spasm Frequency Scale and Insulin Resistance |
0.354; -0.002 | 0.214 |
| PRIMARY Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity |
0.289; -0.103 | 0.41 |
| PRIMARY Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass% |
0.201; 0.287 | 0.511 |
| PRIMARY Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass% |
-0.138; 0.526 | 0.654 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03859960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.