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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait Training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in resting heart rate (rHR) | Resting heart rate (measured in beats per minute) will be measured using a Polar heart rate monitoring system. | 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. | 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. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in diastolic blood pressure (DBP) | Diastolic blood pressure (measured in mmHg) will be measured using a mercury sphygmomanometer. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| changes in PASS, Postural Assessment Scale for Stroke Patients | The PASS has 12 items that assess balancing ability. The minimum score is 0 and the maximum score is 36. Higher scores indicate greater balancing ability. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carrie Bailey, MA | Contact | 402-709-8841 | cbailey8@kumc.edu | |
| Wen Liu | Contact | 913-588-4565 | wliu@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wen Liu, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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single-blinding
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| Leg Cycling Exercise | Other | 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. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention. |
| changes in TIS, Trunk Impairment Scale |
The TIS has 17 items that assess trunk functionality and impairment. The minimum score is 0 and the maximum score is 23. Higher scores indicate greater trunk functionality and less impairment. |
| All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
| changes in MI, Motricity Index | The MI has 6 items (repeated for each arm and leg) that assess motor impairment in stroke patients. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
| changes in RNLI, Reintegration to Normal Living Index | The RNLI has 11 items to assess the extent of the patient's ability to return to normal living activities. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
| changes in MBI, Modified Barthel Index | The MBI has 11 items assessing patients' ability complete a variety of self-care tasks. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
| changes in HADS, Hospital Anxiety and Depression Scale | The HADS has 14 items (7 depression items and 7 anxiety items) to assess depression and anxiety symptoms experienced in the past week. The minimum score is 0 and the maximum score is 21 for depression and anxiety individuals. Higher scores on depression items indicate higher depression. Higher scores on anxiety items indicate higher anxiety. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
| MoCA, Montreal Cognitive Assessment | The MoCA has 8 items that assess cognitive functioning. | All participants will be assessed at baseline (during the evaluation). |
| BMI, Body Mass Index | BMI will be measured by obtaining height and weight. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
| changes in walking endurance and capacity | Walking endurance and capacity will be measured with the total distance covered when performing a 6-minute overground walking test involving walking as far as possible for 6 minutes on a flat, marked course. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
| changes in walking speed, joint motion, and muscle activation | Walking speed, joint motion, and muscle activation will be measured when performing a 6-meter overground walking test involving walking a 6-meter distance on a flat, marked course. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
| Modified Functional Reach Test | The modified functional reach test assess balance by measuring reaching ability 3 times under 3 conditions to assess balance. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
| Fugl Meyer Lower Extremity | The Fugl Meyer Lower Extremity assessment assesses impairment in motor function, balance, sensation and joint functioning with 43 items. | All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.] |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |