Trial Outcomes & Findings for The Effects of Spasticity on Glucose Metabolism in Individuals With Spinal Cord Injury (NCT NCT03859960)

Last Updated: 2020-09-04

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

33 participants

Primary outcome timeframe

One day

Results posted on

2020-09-04

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Motor Complete Group Individuals with American Spinal Injury Association (ASIA) Impairment Scale grades A and B.	Motor Incomplete Group Individuals with American Spinal Injury Association (ASIA) Impairment Scale grades C and D.
Overall Study STARTED	14	19
Overall Study COMPLETED	14	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Motor Complete Group n=14 Participants Individuals with American Spinal Injury Association Impairment Scale (AIS) grades A and B.	Motor Incomplete Group n=19 Participants Individuals with American Spinal Injury Association Impairment Scale (AIS) grades C and D.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Turkey	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Time since injury	47.4 months STANDARD_DEVIATION 52.6 • n=5 Participants	62.1 months STANDARD_DEVIATION 47.8 • n=7 Participants	55.85 months STANDARD_DEVIATION 49.63 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Motor Complete n=14 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of A, B	Motor Incomplete n=19 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of C, D
Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Resistance	-0.692 correlation coefficient	0.23 correlation coefficient

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Motor Complete n=14 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of A, B	Motor Incomplete n=19 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of C, D
Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Insulin Sensitivity	0.797 correlation coefficient	-0.084 correlation coefficient

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Motor Complete n=14 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of A, B	Motor Incomplete n=19 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of C, D
Correlation Between Penn Spasm Frequency Scale and Insulin Resistance	0.354 correlation coefficient	-0.002 correlation coefficient

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Motor Complete n=14 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of A, B	Motor Incomplete n=19 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of C, D
Correlation Between Penn Spasm Frequency Scale and Insulin Sensitivity	0.289 correlation coefficient	-0.103 correlation coefficient

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Motor Complete n=14 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of A, B	Motor Incomplete n=19 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of C, D
Correlation Between Knee Flexor Muscle Modified Ashworth Scale and Total Body Fat-Free Mass%	0.201 correlation coefficient	0.287 correlation coefficient

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Motor Complete n=14 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of A, B	Motor Incomplete n=19 Participants American Spinal Injury Association Impairment Scale (AIS) Grades of C, D
Correlation Between Penn Spasm Frequency Scale and Total Body Fat-Free Mass%	-0.138 correlation coefficient	0.526 correlation coefficient

Adverse Events

Motor Complete

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Motor Incomplete

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MD. Arzu Atici

Fatih Sultan Mehmet Education and Research Hospital

Phone: +905335621208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place