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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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? 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Contact Information
Primary
Carrie Bailey, MA
cbailey8@kumc.edu
402-709-8841
Backup
Wen Liu
wliu@kumc.edu
913-588-4565
Time Frame
Start Date: 2024-02-02
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 72
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov