Recruiting

Gait Training vs. Cycling

Sponsor:

University of Kansas Medical Center

Code:

NCT06247553

Conditions

Stroke

Walking, Difficulty

Cardiovascular Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Gait Training

Leg Cycling Exercise

Study Details

Brief 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.

Conditions

Stroke

Walking, Difficulty

Cardiovascular Injury

Study ID

NCT06247553

Start date

Feb 2, 2024

Status verified date

Jul, 2025

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

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. ]
  • 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. ]
  • glycated hemoglobin (HbA1c) [ Time Frame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention. ]

Central Contacts and Locations

Central contacts

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Keywords

  • stroke
  • unable to walk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-08-01.