Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)
- Conditions
- Spinal Cord Injury
- Interventions
- Behavioral: walking training
- Registration Number
- NCT03940274
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
Cardiovascular disease (CVD) is the common leading cause of death among people with spinal cord injury (SCI) and occurs at an early age in people with SCI as compared to able-bodied people. The findings are consistent in demonstrating a high prevalence of CVD among people with SCI. Lack of physical activity and/or prolonged sitting which is observed in people with SCI due to impaired/loss of motor function is associated with increased risk factors of CVD. By doing this study, researchers hope to learn the effects of walking training on cardiovascular health among people with chronic SCI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Individuals between 18 and 60 years old, who have paraplegia (T1-L2) SCI, and who are scored less than 5 in Functional Independence Measure, Locomotion: Walk
- The onset of SCI must be one year or more at the beginning of the study
- Participants must not be participating in any other similar gait training activities
- Participants must have medical approval from their physician to participate in walk-training
- Major Cardiovascular diseases
- Other neurological diseases
- Muscle spasticity (greater than 3 according to Ashworth scale)
- Severe orthopedic issues such as joint stiffness and fractures
- Osteoporosis (bone mineral density T-score less than - 2.5)[155]
- Inflammatory diseases or infections
- Open wound and pressure ulcer
- Pregnant women
- Cognitive or psychiatric disorders
- Uncontrolled autonomic dysreflexia; sudden increase in blood pressure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention walking training Participants will undergo a walking program using a treadmill, a body-weight support system, and an assistive device.
- Primary Outcome Measures
Name Time Method The perception feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI. From baseline to week 8 Information on perception will be acquired through a questionnaire that will be administered to participants at the end of walk-training program.
The recruitment feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI. From baseline to week 8 Recruitment rate will be assessed by recording the number of participants who are screened for eligibility, those who are excluded because of eligibility criteria, and those who decline to participate in the study.
The retention feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI. From baseline to week 8 Data on retention will be obtained by recording the number of participants who drop out during the study along with their reasons.
The compliance feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI. From baseline to week 8 Data on compliance rate will be documented during a period of training. The total number of completed sessions and incomplete sessions along with reasons for absence will be recorded throughout the study.
The walking performance (walking time) feasibility of an 8-week walk-training program in patients with chronic SCI. From baseline to week 8 The time of walking (minutes) that a participant will be able to walk on a treadmill during each training session will be recorded.
The walking performance (number of stepping) feasibility of an 8-week walk-training program in patients with chronic SCI. From baseline to week 8 The number of stepping during each training session will be recorded using a step tracker.
Correlations between changes in four factors (muscle activity, cardiac autonomic function, spasticity, and lung capacity) and changes in heart rate after the walk-training program. Change from baseline to week 8 The resting heart rate will be measured during sitting position after 5 minutes rest. Exercise heart rate will be measured during a graded treadmill walking test with the same testing conditions pre- and post-training. The signal activity of four muscles in the lower limbs (biceps femoris, rectus femoris, gastrocnemius medialis, and tibialis anterior) will be measured using electromyography (EMG) system. The EMG recording will be obtained during walking on a treadmill. The average root-mean-square EMG for each muscle during gait cycle will be calculated. Cardiac autonomic function will be determined through power spectral of heart rate variability (HRV) using electrocardiography system. HRV frequency domain, including total power, low frequency (LF) and high frequency (HF) powers, and ratio of LF/HF, will be calculated and analyzed. Muscle spasticity for the lower extremities will be assessed through Modified Tardieu Scale. lung capacity will be measured through a spirometer.
The walking performance (treadmill walking speed) feasibility of an 8-week walk-training program in patients with chronic SCI. From baseline to week 8 The amount of treadmill speed (miles/hour) that a participant will be able to walk will be recorded during each training session.
- Secondary Outcome Measures
Name Time Method Changes in the level of glycated hemoglobin (HbA1c) after 8-week walk-training program. Change from baseline to week 8 The level of HbA1c will be assessed using a device A1CNow+ System.
Changes in the level of pro-inflammatory markers after 8-week walk-training program. Change from baseline to week 8 For inflammatory markers, serum concentrations of C-reactive protein and interleukin-6 will be determined using an enzyme-linked immunosorbent assay.
Changes in lipid profile after 8-week walk-training program. Change from baseline to week 8 For lipid profile, we will assess serum concentrations of total cholesterol, low density lipoprotein and high density lipoprotein using an enzymatic colorimetric assay.
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States