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

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

Recruiting
18-80 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Stroke
    Walking
    Difficulty
    Cardiovascular Injury

NCT06247553

University of Kansas Medical Center

13 August 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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