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

NCT03940274 | Completed

• 1 other identifier: STUDY00142564
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Cardiovascular health; Walking training

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Changes in lipid profile after 8-week walk-training program.

  Change from baseline to week 8

• Changes in the level of glycated hemoglobin (HbA1c) after 8-week walk-training program.

  Change from baseline to week 8

• Changes in the level of pro-inflammatory markers after 8-week walk-training program.

  Change from baseline to week 8

Other Outcomes (6)

• Changes in lower-limbs muscle strength after 8-week walk-training program.

  Change from baseline to week 8

• Changes in lower-limbs muscle spasticity after 8-week walk-training program.

  Change from baseline to week 8

• Changes in muscle spasticity after 8-week walk-training program.

  Change from baseline to week 8

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will undergo a walking program using a treadmill, a body-weight support system, and an assistive device.

Behavioral: walking training

Interventions

walking training BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• 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.

  PMID: 32780981 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Wen Liu, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: May 7, 2019
• Study Start: December 4, 2018
• Primary Completion: September 29, 2019
• Study Completion: September 29, 2019
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)