StrokeNCT06247553
To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors
A study testing Gait Training and Leg Cycling Exercise in people with Stroke and Walking, Difficulty, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a gait (walking) training program in non-ambulatory (unable to walk) chronic stroke survivors. The main question it aims to answer is: Will gait training improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise?… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Walking, Difficulty, Cardiovascular Injury
- What is being tested?
- Gait Training and Leg Cycling Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must be 18 to 80 years old
- male or female
- independent ambulation before stroke
- able to understand and follow verbal commands in English
- have physicians' approval for exercise
- be in a stable medical condition
Show all 9Show fewer
- must be after the first stroke
- unable to walk independently
- in the chronic stage (at least 6 months after stroke onset)
Who cannot join
- musculoskeletal or other disorders that prevent the participant from participating in the exercise
- blood pressure higher than 200/110 mm Hg
- diagnosis of severe depression
- functionally restricted passive movement in the major joints of lower limbs
- unable to speak or understand English
- unable to travel to the Research Laboratory
- currently participate in other walking training using treadmill with or without a body-weight support system
- body weight greater than 400 lbs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Carrie Bailey, cbailey8@kumc.edu
Wen Liu, 913-588-4565, wliu@kumc.edu
About this study
The goal of this clinical trial is to test a gait (walking) training program in non-ambulatory (unable to walk) chronic stroke survivors. The main question it aims to answer is:
- Will gait training improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise?
Participants will walk on a treadmill with a partial body-weight support system and the gait training device. Researchers will compare with a leg-cycling exercise to see if there are significant differences in resting heart rate, systolic blood pressure (SBP), and A1c levels in the blood.
Read the detailed description
Stroke is a leading cause of death and permanent disability. About 795,000 strokes occur in the US each year and more than seven million Americans are living with effects of stroke. Cardiovascular diseases are commonly presented and are primary causes of death in stroke survivors. Numerous studies have proven the benefits of walking or other forms of aerobic exercise for cardiovascular and pulmonary function in people after stroke. This proposed randomized controlled efficacy trial will primarily examine whether the investigators' gait training can improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise. The investigators have recently developed a novel gait training device and a training program. The experimental group in the proposed project will undergo an 8-week gait training program using a treadmill with body-weight support and the investigators' novel gait training device. The control group will receive an 8-week sitting leg cycling exercise program with similar exercise intensity, frequency, and duration. The proposed project will examine differences between the two groups using a set of comprehensive outcome assessments of cardiovascular, pulmonary, and sensorimotor functions.
- Conditions
- Stroke, Walking, Difficulty, Cardiovascular Injury
- Being tested
- Gait Training, Leg Cycling Exercise
- Keywords
- stroke, unable to walk
- Medical subject headings
- Stroke, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait TrainingOther
The gait training in the experimental group will use a treadmill with a partial body-weight support system and our gait training device. A gait training session will include 2-minute warming up at the beginning and 2-minute cooling down at the end, at a treadmill speed of 0.6 mph. After the warming up, the treadmill speed will increase at every two minutes by an increment of 0.2 mph. Participant's heart rate will be monitored throughout the training session by using a Polar OH1 optical HR sensor placed in the participant's left forearm. Researchers will stop the increase and maintain the same treadmill speed after the HR reaching the target heart rate zone of 50% - 60% of age-predicted heart rate reserve.
Leg Cycling ExerciseOther
The leg cycling exercise will use a stationary bicycle and the similar protocol as in the experimental group. The cycling exercise will include 2-minute warming up in the beginning and 2-minute cooling down at the end with a speed of 10 rpm and resistance of level 1 of 4. After warming up, the speed will increase at every two minutes by an increment of 5 rpm until reaching the target heart rate zone of 50% - 60% of age-predicted maximum heart rate. If the participant cannot tolerate any more increase in cycling speed before reaching the target heart rate, the resistance will be increased. The training duration will be individualized at the beginning and increase weekly by 5 minutes, depending on the tolerance of the participant, up to the maximum of 30 minutes. Both heart rate and blood pressure will be monitored before, during, and after each session to ensure safety. Each session including setting up will be about one hour.
| Study group | Role | What they receive |
|---|---|---|
| Gait Training | Experimental | The gait training in the experimental group will use a treadmill with a partial body-weight support system and our gait training device. A gait training session will include 2-minute warming up at the beginning and 2-minute cooling down at the end, at a treadmill speed of 0.6 mph. After the warming up, the treadmill speed will increase at every two minutes by an increment of 0.2 mph. Participant's heart rate will be monitored throughout the training session by using a Polar OH1 optical HR sensor placed in the participant's left forearm. Reseachers will stop the increase and maintain the same treadmill speed after the HR reaching the target heart rate zone of 50% - 60% of age-predicted heart rate reserve. Receives: Other: Gait Training |
| Leg Cycling Exercise | Active comparator | The leg cycling exercise will use a stationary bicycle and the similar protocol as in the experimental group. The cycling exercise will include 2-minute warming up in the beginning and 2-minute cooling down at the end with a speed of 10 rpm and resistance of level 1 of 4. After warming up, the speed will increase at every two minutes by an increment of 5 rpm until reaching the target heart rate zone of 50% - 60% of age-predicted maximum heart rate. If the participant cannot tolerate any more increase in cycling speed before reaching the target heart rate, the resistance will be increased. The training duration will be individualized at the beginning and increase weekly by 5 minutes, depending on the tolerance of the participant, up to the maximum of 30 minutes. Both heart rate and blood pressure will be monitored before, during, and after each session to ensure safety. Each session including setting up will be about one hour. Receives: Other: Leg Cycling Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in resting heart rate (rHR)
Resting heart rate (measured in beats per minute) will be measured using a Polar heart rate monitoring system.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
systolic blood pressure (SBP)
Systolic blood pressure (measured in mmHg) will be measured using a mercury sphygmomanometer.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
glycated hemoglobin (HbA1c)
HbA1c levels will be measured by collecting a drop of blood from the middle finger of the unaffected hand and use the A1CNow+ System for analysis.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
Secondary outcomes (11)
changes in diastolic blood pressure (DBP)
Diastolic blood pressure (measured in mmHg) will be measured using a mercury sphygmomanometer.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in forced vital capacity (FVC)
To obtain FVC measurements (measured in liters (L)) nose clip will be used, and subject's lips will be sealed around the mouthpiece to prevent air from leaking. The study team member will verbally encourage the subject to keep inhaling and exhaling at the maximum capacity. For FVC measurement, the subject will be instructed to maximally inhale, and immediately exhale forcibly and maximally. This test will be repeated at least three times. At least one minute will be allowed between each repetition to avoid fatigue.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
clinical measurement of Functional Ambulation Category (FAC)
The measurement of FAC will determine an individual's walking ability based on the amount of human assistance needed. It includes six categories, with Category 0 indicating nonfunctional ambulation and Category 5 - independent ambulation on varying surfaces.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in exercise heart rate (eHR)
Heart rate will be obtained using a Polar heart rate monitoring system.
Measured: These will be measured pre- and post-exercise for the intervention group.
changes in low-density lipoprotein cholesterol (LDL-C)
A blood sample will be drawn from the antecubital vein in the unaffected arm to be analyzed for plasma cholesterol (LDL-C) levels.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in vital capacity (VC)
To obtain VC measurements (measured in liters (L)) nose clip will be used, and subject's lips will be sealed around the mouthpiece to prevent air from leaking. The study team member will verbally encourage the subject to keep inhaling and exhaling at the maximum capacity. The subject will sit and first be asked to breathe normally three times. The subject will then be instructed immediately to maximally inhale or exhale and repeat four times. This test will be repeated at least three times. At least one minute will be allowed between each repetition to avoid fatigue.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in Berg Balance Scale (BBS) score
The BBS is a test consisting of 14 items, designed to measure balance performance in sitting, standing, and weight transfer activities. The minimum score is 0 and the maximum score is 56. Higher scores indicate greater balance performance.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in muscle activity of the affected leg for participants in the intervention group
The muscle activity will be measured by the recorded muscle electromyogram (EMG) signals.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in heart rate variability (HRV)
Heart rate variability will be obtained using electrocardiography (ECG).
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in stroke volume (SV)
Stroke Volume (SV), an indication of cardiac functioning, will be measured by non-invasive impedance cardiography.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in cardiac output (CO)
Cardiac Output (CO), an indication of cardiac functioning, will be measured by non-invasive impedance cardiography.
Measured: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start2 Feb 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
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
- NCT06247553
- Sponsor's protocol ID
- MOD00042952
- Status last verified
- Jul 2025
- First submitted
- 22 Mar 2023
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors
- ClinicalTrials.gov ID
- NCT06247553
- Acronym / sponsor ID
- MOD00042952
- Conditions
- Stroke, Walking, Difficulty, Cardiovascular Injury
- Keywords
- stroke, unable to walk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 8 Feb 2024 (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.
The goal of this clinical trial is to test a gait (walking) training program in non-ambulatory (unable to walk) chronic stroke survivors. The main question it aims to answer is:
- Will gait training improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise?
Participants will walk on a treadmill with a partial body-weight support system and the gait training device. Researchers will compare with a leg-cycling exercise to see if there are significant differences in resting heart rate, systolic blood pressure (SBP), and A1c levels in the blood.
Detailed description
Stroke is a leading cause of death and permanent disability. About 795,000 strokes occur in the US each year and more than seven million Americans are living with effects of stroke. Cardiovascular diseases are commonly presented and are primary causes of death in stroke survivors. Numerous studies have proven the benefits of walking or other forms of aerobic exercise for cardiovascular and pulmonary function in people after stroke. This proposed randomized controlled efficacy trial will primarily examine whether the investigators' gait training can improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise. The investigators have recently developed a novel gait training device and a training program. The experimental group in the proposed project will undergo an 8-week gait training program using a treadmill with body-weight support and the investigators' novel gait training device. The control group will receive an 8-week sitting leg cycling exercise program with similar exercise intensity, frequency, and duration. The proposed project will examine differences between the two groups using a set of comprehensive outcome assessments of cardiovascular, pulmonary, and sensorimotor functions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait Training | Experimental | Other: Gait TrainingThe gait training in the experimental group will use a treadmill with a partial body-weight support system and our gait training device. A gait training session will include 2-minute warming up at the beginning and 2-minute cooling down at the end, at a treadmill speed of 0.6 mph. After the warming up, the treadmill speed will increase at every two minutes by an increment of 0.2 mph. Participant's heart rate will be monitored throughout the training session by using a Polar OH1 optical HR sensor placed in the participant's left forearm. Reseachers will stop the increase and maintain the same treadmill speed after the HR reaching the target heart rate zone of 50% - 60% of age-predicted heart rate reserve. |
| Leg Cycling Exercise | Active comparator | Other: Leg Cycling ExerciseThe leg cycling exercise will use a stationary bicycle and the similar protocol as in the experimental group. The cycling exercise will include 2-minute warming up in the beginning and 2-minute cooling down at the end with a speed of 10 rpm and resistance of level 1 of 4. After warming up, the speed will increase at every two minutes by an increment of 5 rpm until reaching the target heart rate zone of 50% - 60% of age-predicted maximum heart rate. If the participant cannot tolerate any more increase in cycling speed before reaching the target heart rate, the resistance will be increased. The training duration will be individualized at the beginning and increase weekly by 5 minutes, depending on the tolerance of the participant, up to the maximum of 30 minutes. Both heart rate and blood pressure will be monitored before, during, and after each session to ensure safety. Each session including setting up will be about one hour. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- must be 18 to 80 years old
- male or female
- independent ambulation before stroke
- able to understand and follow verbal commands in English
- have physicians' approval for exercise
Key exclusion criteria (8 listed)
- musculoskeletal or other disorders that prevent the participant from participating in the exercise
- blood pressure higher than 200/110 mm Hg
- diagnosis of severe depression
- functionally restricted passive movement in the major joints of lower limbs
- unable to speak or understand English
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 |
|---|---|---|
| Gait TrainingThe gait training in the experimental group will use a treadmill with a partial body-weight support system and our gait training device. A gait training session will include 2-minute warming up at the beginning and 2-minute cooling down at the end, at a treadmill speed of 0.6 mph. After the warming up, the treadmill speed will increase at every two minutes by an increment of 0.2 mph. Participant's heart rate will be monitored throughout the training session by using a Polar OH1 optical HR sensor placed in the participant's left forearm. Researchers will stop the increase and maintain the same treadmill speed after the HR reaching the target heart rate zone of 50% - 60% of age-predicted heart rate reserve. | Other | Gait Training |
| Leg Cycling ExerciseThe leg cycling exercise will use a stationary bicycle and the similar protocol as in the experimental group. The cycling exercise will include 2-minute warming up in the beginning and 2-minute cooling down at the end with a speed of 10 rpm and resistance of level 1 of 4. After warming up, the speed will increase at every two minutes by an increment of 5 rpm until reaching the target heart rate zone of 50% - 60% of age-predicted maximum heart rate. If the participant cannot tolerate any more increase in cycling speed before reaching the target heart rate, the resistance will be increased. The training duration will be individualized at the beginning and increase weekly by 5 minutes, depending on the tolerance of the participant, up to the maximum of 30 minutes. Both heart rate and blood pressure will be monitored before, during, and after each session to ensure safety. Each session including setting up will be about one hour. | Other | Leg Cycling Exercise |
Primary outcome
changes in resting heart rate (rHR)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
Resting heart rate (measured in beats per minute) will be measured using a Polar heart rate monitoring system.
systolic blood pressure (SBP)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
Systolic blood pressure (measured in mmHg) will be measured using a mercury sphygmomanometer.
glycated hemoglobin (HbA1c)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
HbA1c levels will be measured by collecting a drop of blood from the middle finger of the unaffected hand and use the A1CNow+ System for analysis.
11 secondary outcomes
changes in diastolic blood pressure (DBP)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in forced vital capacity (FVC)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
clinical measurement of Functional Ambulation Category (FAC)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in exercise heart rate (eHR)
Time frame: These will be measured pre- and post-exercise for the intervention group.
changes in low-density lipoprotein cholesterol (LDL-C)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in vital capacity (VC)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in Berg Balance Scale (BBS) score
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in muscle activity of the affected leg for participants in the intervention group
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in heart rate variability (HRV)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in stroke volume (SV)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
changes in cardiac output (CO)
Time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- 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.
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 Gait Training and Leg Cycling Exercise in people with Stroke and Walking, Difficulty, 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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carrie Bailey, MA (402-709-8841, cbailey8@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in resting heart rate (rHR) (time frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2025.