To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Walking, Difficulty; Cardiovascular Injury
• Intervention / Treatment: Other: Gait Training; Other: Leg Cycling Exercise

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carrie Bailey, MA; Phone Number: 402-709-8841; Email: cbailey8@kumc.edu
• Study Contact Backup: Name: Wen Liu; Phone Number: 913-588-4565; Email: wliu@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Wen Liu; Phone Number: 913-588-4565; Email: wliu@kumc.edu
      • Contact: Carrie Bailey; Email: cbailey8@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• must be after the first stroke
• unable to walk independently
• in the chronic stage (at least 6 months after stroke onset)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gait Training; 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.	Other: Gait Training; 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.
Active Comparator: Leg Cycling Exercise; 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.	Other: Leg Cycling Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)	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.

Other Outcome Measures

Outcome Measure	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.]
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.]

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: stroke; unable to walk
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Mobility Limitation
• Other Study ID Numbers: MOD00042952

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