To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
must be 18 to 80 years old
male or female
independent ambulation before stroke
able to understand and follow verbal commands in English
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Gait Training
Other interventionThe 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 interventionThe 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Gait TrainingExperimental treatment 1 intervention
Group B: Leg Cycling ExerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
changes in resting heart rate (rHR)
Resting heart rate (measured in beats per minute) will be measured using a Polar heart rate monitoring system.
Time frame
All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.2
systolic blood pressure (SBP)
Systolic blood pressure (measured in mmHg) will be measured using a mercury sphygmomanometer.
Time frame
All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.3
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.
Time frame
All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.Secondary outcomes
1
changes in diastolic blood pressure (DBP)
Diastolic blood pressure (measured in mmHg) will be measured using a mercury sphygmomanometer.
Time frame
All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.2
changes in forced vital capacity (FVC)
To obtain FVC measurements (measured in liters (L)) nose clip will be used, and subject's lips will be sealed around the mouthpiece to prevent air from leaking. The study team member will verbally encourage the subject to keep inhaling and exhaling at the maximum capacity. For FVC measurement, the subject will be instructed to maximally inhale, and immediately exhale forcibly and maximally. This test will be repeated at least three times. At least one minute will be allowed between each repetition to avoid fatigue.
Time frame
All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.3
clinical measurement of Functional Ambulation Category (FAC)
The measurement of FAC will determine an individual's walking ability based on the amount of human assistance needed. It includes six categories, with Category 0 indicating nonfunctional ambulation and Category 5 - independent ambulation on varying surfaces.
Time frame
All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.4
changes in exercise heart rate (eHR)
Heart rate will be obtained using a Polar heart rate monitoring system.
Time frame
These will be measured pre- and post-exercise for the intervention group.Other outcomes
1
changes in PASS, Postural Assessment Scale for Stroke Patients
The PASS has 12 items that assess balancing ability. The minimum score is 0 and the maximum score is 36. Higher scores indicate greater balancing ability.
Time frame
All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]2
changes in TIS, Trunk Impairment Scale
The TIS has 17 items that assess trunk functionality and impairment. The minimum score is 0 and the maximum score is 23. Higher scores indicate greater trunk functionality and less impairment.
Time frame
All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]3
changes in MI, Motricity Index
The MI has 6 items (repeated for each arm and leg) that assess motor impairment in stroke patients.
Time frame
All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]4
changes in RNLI, Reintegration to Normal Living Index
The RNLI has 11 items to assess the extent of the patient's ability to return to normal living activities.
Time frame
All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]Sponsors and contacts
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Source ClinicalTrials.gov