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

NCT06247553 | Recruiting DMC

• 1 other identifier: MOD00042952
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; unable to walk

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• changes in diastolic blood pressure (DBP)

  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)

  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)

  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)

  These will be measured pre- and post-exercise for the intervention group.

• changes in low-density lipoprotein cholesterol (LDL-C)

  All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.

Other Outcomes (12)

• changes in PASS, Postural Assessment Scale for Stroke Patients

  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

  All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]

• changes in MI, Motricity Index

  All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]

Study Arms (2)

Gait Training

EXPERIMENTAL

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

Leg Cycling Exercise

ACTIVE COMPARATOR

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

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.

Gait Training

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.

Leg Cycling Exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wen Liu, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carrie Bailey, MA

CONTACT

402-709-8841; cbailey8@kumc.edu

Wen Liu

CONTACT

913-588-4565; wliu@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single-blinding
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: February 8, 2024
• Study Start: February 2, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)