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Gait Training for Stroke

N/A

Recruiting

Led By Wen Liu, PhD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Independent ambulation before stroke

Must be after the first stroke

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial aims to see if a walking training program can improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a cycling exercise. Participants will walk on a treadmill with support and a special

Who is the study for?

This trial is for chronic stroke survivors who currently cannot walk. It's designed to help them develop a walking exercise program. To join, participants must have had a stroke that resulted in limited mobility and difficulty with walking.Check my eligibility

What is being tested?

The study is testing whether gait training using a treadmill and partial body-weight support can improve cardiovascular health more effectively than leg cycling exercises. Researchers will measure heart rate, blood pressure, and A1c levels to assess improvements.See study design

What are the potential side effects?

Potential side effects may include muscle soreness or fatigue due to the physical nature of the exercises. There might also be an increased risk of falls during gait training for those with severe balance issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was able to walk on my own before having a stroke.

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I have had a stroke before.

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I cannot walk on my own.

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I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and all participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

changes in resting heart rate (rHR)

glycated hemoglobin (HbA1c)

systolic blood pressure (SBP)

Secondary outcome measures

changes in Berg Balance Scale (BBS) score

changes in cardiac output (CO)

changes in diastolic blood pressure (DBP)

+8 more

Other outcome measures

BMI, Body Mass Index

MoCA, Montreal Cognitive Assessment

changes in HADS, Hospital Anxiety and Depression Scale

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Gait TrainingExperimental Treatment1 Intervention

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.

Group II: Leg Cycling ExerciseActive Control1 Intervention

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,198 Total Patients Enrolled

8 Trials studying Stroke

611 Patients Enrolled for Stroke

Wen Liu, PhDPrincipal InvestigatorUniversity of Kansas Medical Center

6 Previous Clinical Trials

204 Total Patients Enrolled

1 Trials studying Stroke

20 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial allow individuals who have reached the age of 18 to participate?

"Potential participants must be over 18 years of age but under the age of 80 to qualify for enrollment in this research."

Answered by AI

What are the anticipated results that this research aims to achieve?

"The primary objective of this research, to be evaluated over an 8-week period, is the assessment of systolic blood pressure (SBP). Additional parameters include changes in cardiac output (CO) assessed through non-invasive impedance cardiography. Furthermore, variations in diastolic blood pressure (DBP), measured using a mercury sphygmomanometer, and alterations in forced vital capacity (FVC), gauged by instructing subjects to inhale deeply and exhale forcefully into a spirometer with nose clips applied for accuracy will also be examined."

Answered by AI

Which specific criteria must individuals meet in order to be eligible for participation in this medical study?

"To qualify for participation, individuals must have suffered a stroke and be aged between 18 to 80 years. The trial aims to enlist a total of 72 participants."

Answered by AI

What is the total number of individuals actively engaged in this medical study?

"Indeed, data on clinicaltrials.gov indicates that this particular medical investigation is actively seeking participants. Originally listed on February 2nd, 2024, the study was last revised on February 6th, 2024. The research aims to enroll a total of 72 patients from one designated site."

Answered by AI

Is the enrollment process currently open for this research study?

"Indeed, as per clinicaltrials.gov, this research endeavor is presently in need of volunteers. The trial was initially disclosed on February 2nd, 2024 and underwent its latest update on February 6th, 2024. To complete the study successfully, a total of 72 participants are sought after from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06247553.

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