Back to resultsWalk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
walking training
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Cardiovascular health, Walking training
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Participants will undergo a walking program using a treadmill, a body-weight support system, and an assistive device.
Outcomes
Primary Outcome Measures
The recruitment feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
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 perception feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
Information on perception will be acquired through a questionnaire that will be administered to participants at the end of walk-training program.
The compliance feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
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 retention feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
Data on retention will be obtained by recording the number of participants who drop out during the study along with their reasons.
The walking performance (walking time) feasibility of an 8-week walk-training program in patients with chronic SCI.
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 (treadmill walking speed) feasibility of an 8-week walk-training program in patients with chronic SCI.
The amount of treadmill speed (miles/hour) that a participant will be able to walk will be recorded during each training session.
The walking performance (number of stepping) feasibility of an 8-week walk-training program in patients with chronic SCI.
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.
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.
Secondary Outcome Measures
Changes in lipid profile after 8-week walk-training program.
For lipid profile, we will assess serum concentrations of total cholesterol, low density lipoprotein and high density lipoprotein using an enzymatic colorimetric assay.
Changes in the level of glycated hemoglobin (HbA1c) after 8-week walk-training program.
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.
For inflammatory markers, serum concentrations of C-reactive protein and interleukin-6 will be determined using an enzyme-linked immunosorbent assay.
Full Information
NCT ID
NCT03940274
First Posted
April 4, 2019
Last Updated
September 3, 2020
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03940274
Brief Title
Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)
Official Title
Benefits of a Walk-Training Program on Cardiovascular Health in Individuals With Chronic Spinal Cord Injury (SCI)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
September 29, 2019 (Actual)
Study Completion Date
September 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Cardiovascular health, Walking training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will undergo a walking program using a treadmill, a body-weight support system, and an assistive device.
Intervention Type
Behavioral
Intervention Name(s)
walking training
Intervention Description
Participants will receive three sessions a week of BWSTT with assistive training device for 8 weeks; a total of 24 sessions. The duration of each training session will an hour. During walk-training, the participant will wear a harness which is attached to an overhead motorized lift to provide body-weight support and to prevent the risk of falling.
Primary Outcome Measure Information:
Title
The recruitment feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
Description
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.
Time Frame
From baseline to week 8
Title
The perception feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
Description
Information on perception will be acquired through a questionnaire that will be administered to participants at the end of walk-training program.
Time Frame
From baseline to week 8
Title
The compliance feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
Description
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.
Time Frame
From baseline to week 8
Title
The retention feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
Description
Data on retention will be obtained by recording the number of participants who drop out during the study along with their reasons.
Time Frame
From baseline to week 8
Title
The walking performance (walking time) feasibility of an 8-week walk-training program in patients with chronic SCI.
Description
The time of walking (minutes) that a participant will be able to walk on a treadmill during each training session will be recorded.
Time Frame
From baseline to week 8
Title
The walking performance (treadmill walking speed) feasibility of an 8-week walk-training program in patients with chronic SCI.
Description
The amount of treadmill speed (miles/hour) that a participant will be able to walk will be recorded during each training session.
Time Frame
From baseline to week 8
Title
The walking performance (number of stepping) feasibility of an 8-week walk-training program in patients with chronic SCI.
Description
The number of stepping during each training session will be recorded using a step tracker.
Time Frame
From baseline to week 8
Title
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.
Description
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.
Time Frame
Change from baseline to week 8
Secondary Outcome Measure Information:
Title
Changes in lipid profile after 8-week walk-training program.
Description
For lipid profile, we will assess serum concentrations of total cholesterol, low density lipoprotein and high density lipoprotein using an enzymatic colorimetric assay.
Time Frame
Change from baseline to week 8
Title
Changes in the level of glycated hemoglobin (HbA1c) after 8-week walk-training program.
Description
The level of HbA1c will be assessed using a device A1CNow+ System.
Time Frame
Change from baseline to week 8
Title
Changes in the level of pro-inflammatory markers after 8-week walk-training program.
Description
For inflammatory markers, serum concentrations of C-reactive protein and interleukin-6 will be determined using an enzyme-linked immunosorbent assay.
Time Frame
Change from baseline to week 8
Other Pre-specified Outcome Measures:
Title
Changes in lower-limbs muscle strength after 8-week walk-training program.
Description
Muscle strength will be evaluated using lower extremity motor score (LEMS), according to guidelines of the American Spinal Injury Association. LEMS is a manual muscle testing that assesses the strength of five key muscle groups of the lower extremities bilaterally: the hip flexors, knee extensors, ankle dorsiflexors, great toe extensors, and ankle plantarflexors. Each muscle group will be graded from 0 (absence of muscle contraction) to 5 (active movement with the full range of motion against full resistance). The total score of LEMS ranges from 0 to 50.
Time Frame
Change from baseline to week 8
Title
Changes in lower-limbs muscle spasticity after 8-week walk-training program.
Description
Muscle spasticity will be assessed through the Modified Ashworth Scale (MAS). MAS is a subjective scale for clinical assessment of involuntary resistance to passive movement and, hence, muscle tone [166, 168]. An examiner will move the patient's limb through its full range of movement and will rate the amount of resistance felt. Resistance is rated based on a 6-point scale (grades 0, 1, 1+, 2, 3, 4), with lower scores indicating no spasticity and higher scores representing increasing resistance to passive movement.
Time Frame
Change from baseline to week 8
Title
Changes in muscle spasticity after 8-week walk-training program.
Description
Muscle spasticity will subjectively be measured using the Penn Spasm Frequency Scale (PSFS). PSDS is a two components self-report questionnaire that assesses an individual's perception of spasticity frequency and severity. The first component is a 5-point scale assessing the frequency with which spasms occur ranging from "0 = No spasms" to "4 = Spontaneous spasms occurring more than ten times per hour. The second component is a 3-point scale assessing the severity of spasms ranging from "1 = Mild" to "3 = Severe". If an individual indicates that he/she has no spasms in the first component, the second component is not evaluated.
Time Frame
Change from baseline to week 8
Title
Changes in functional independence after 8-week walk-training program.
Description
The Spinal Cord Independence Measure (SCIM) self-report version (SCIM-SR) will be utilized to evaluate the level of functional independence. This questionnaire contains 17 items, divided into three subscales: self-care (items 1-4), respiration and sphincter management (items 5-8), and mobility ability (items 9-17). The total score of SCM-SR ranges from 0 to100, which indicates the level of functional independence. The higher score represents a higher level of functional independence.
Time Frame
Change from baseline to week 8
Title
Changes in the level of depression, anxiety and stress after 8-week walk-training program.
Description
Depression Anxiety Stress Scales-21 (DASS-21) will be used to determine the level of depression, anxiety, and stress. DASS-21 is a self-administered questionnaire that is designed to assess the negative emotional states of depression, anxiety, and stress over the past few weeks. It consists of three subscales with seven items in each subscale (total of 21 items). The response to each item is given on a 4-point Likert scale ranging from 0 = "Did not apply to me at all" to 3 = "Applied to me very much or most of the time". The score for each subscale is calculated by summing the scores for the relevant items. The low score indicates a normal level, whereas the high score indicates an extremely severe level of depression, anxiety, and stress.
Time Frame
Change from baseline to week 8
Title
Changes in health-related quality of life (HRQOL) after 8-week walk-training program.
Description
Change in HRQOL will be assessed via the Short form-36 (SF-36). SF-36 is a self-reported, 36-items questionnaire that assesses eight domains of perceived HRQOL during the previous 4 weeks.[179, 180] The eight domains include physical functioning, role-physical functioning, bodily pain, general health, vitality, social functioning, role-emotional functioning, and mental health. The score for each domain ranges from 0-100. The higher score represents better HRQOL.
Time Frame
Change from baseline to week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Liu, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32780981
Citation
Alajam RA, Alqahtanti AS, Frederick J, Liu W. The feasibility of an 8-Week walking training program using a novel assistive gait training device in individuals with spinal cord injury. Disabil Rehabil Assist Technol. 2022 Aug;17(6):658-667. doi: 10.1080/17483107.2020.1805801. Epub 2020 Aug 11.
Results Reference
derived
Learn more about this trial
Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)
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