Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)

Benefits of a Walk-Training Program on Cardiovascular Health in Individuals With Chronic Spinal Cord Injury (SCI)

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Behavioral: walking training

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will undergo a walking program using a treadmill, a body-weight support system, and an assistive device.	Behavioral: walking training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to week 8
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.	From baseline to week 8
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.	From baseline to week 8
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.	From baseline to week 8
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.	From baseline to week 8
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.	From baseline to week 8
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.	From baseline to week 8
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.	Change from baseline to week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to week 8
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.	Change from baseline to week 8
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.	Change from baseline to week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lower-limbs muscle strength after 8-week walk-training program.	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.	Change from baseline to week 8
Changes in lower-limbs muscle spasticity after 8-week walk-training program.	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.	Change from baseline to week 8
Changes in muscle spasticity after 8-week walk-training program.	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.	Change from baseline to week 8
Changes in functional independence after 8-week walk-training program.	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.	Change from baseline to week 8
Changes in the level of depression, anxiety and stress after 8-week walk-training program.	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.	Change from baseline to week 8
Changes in health-related quality of life (HRQOL) after 8-week walk-training program.	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.	Change from baseline to week 8

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Wen Liu, PhD, University of Kansas Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): September 29, 2019
• Study Completion (Actual): September 29, 2019

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Cardiovascular health; Walking training
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: STUDY00142564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No