Spinal Cord InjuryNCT03940274
Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)
A study testing walking training in people with Spinal Cord Injury, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- walking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 29 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Open wound and pressure ulcer
- Pregnant women
- Cognitive or psychiatric disorders
- Uncontrolled autonomic dysreflexia; sudden increase in blood pressure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
- Conditions
- Spinal Cord Injury
- Being tested
- walking training
- Keywords
- Cardiovascular health, Walking training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will undergo a walking program using a treadmill, a body-weight support system, and an assistive device. Receives: Behavioral: walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to week 8
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start4 Dec 2018
- Primary completion29 Sep 2019
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Liu, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940274
- Sponsor's protocol ID
- STUDY00142564
- Status last verified
- Sep 2020
- First submitted
- 4 Apr 2019
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32780981
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a Walk-Training Program on Cardiovascular Health in Individuals With Chronic Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT03940274
- Acronym / sponsor ID
- STUDY00142564
- Conditions
- Spinal Cord Injury
- Keywords
- Cardiovascular health, Walking training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 29 Sep 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: walking trainingParticipants will undergo a walking program using a treadmill, a body-weight support system, and an assistive device. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking trainingParticipants 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. | Behavioural | Intervention |
Primary outcome
The recruitment feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
Time frame: 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 perception feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
Time frame: 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 compliance feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
Time frame: 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 retention feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
Time frame: 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 walking performance (walking time) feasibility of an 8-week walk-training program in patients with chronic SCI.
Time frame: 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 (treadmill walking speed) feasibility of an 8-week walk-training program in patients with chronic SCI.
Time frame: 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.
The walking performance (number of stepping) feasibility of an 8-week walk-training program in patients with chronic SCI.
Time frame: 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.
Time frame: 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.
3 secondary outcomes
Changes in lipid profile after 8-week walk-training program.
Time frame: Change from baseline to week 8
Changes in the level of glycated hemoglobin (HbA1c) after 8-week walk-training program.
Time frame: Change from baseline to week 8
Changes in the level of pro-inflammatory markers after 8-week walk-training program.
Time frame: Change from baseline to week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Derived from this study: PubMed 32780981Alajam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Liu, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking training in people with Spinal Cord Injury, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recruitment feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI. (time frame: From baseline to week 8). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.