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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06247553
Status
Recruiting
Apply to this trial

Conditions

  • Cardiovascular Injury
  • Stroke
  • Walking, Difficulty

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 2, 2024
Status verified
Jul 2025
Primary completion
Aug 31, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Carrie Bailey
[email protected]
Wen Liu
[email protected]
913-588-4565

Find similar trials in Kansas City, KS

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Kansas Medical Center· Kansas City, KS

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