Clinical trial NCT06247553: To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors
Official title: To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Walking, Difficulty
Cardiovascular Injury
Keywords: stroke
unable to walk
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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 criteria: 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

Primary outcomes:
measure: changes in resting heart rate (rHR)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: systolic blood pressure (SBP)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: glycated hemoglobin (HbA1c)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
Secondary outcomes:
measure: changes in diastolic blood pressure (DBP)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: changes in forced vital capacity (FVC)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: clinical measurement of Functional Ambulation Category (FAC)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: changes in exercise heart rate (eHR)
timeFrame: These will be measured pre- and post-exercise for the intervention group.
measure: changes in low-density lipoprotein cholesterol (LDL-C)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: changes in vital capacity (VC)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: changes in Berg Balance Scale (BBS) score
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: changes in muscle activity of the affected leg for participants in the intervention group
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: changes in heart rate variability (HRV)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: changes in stroke volume (SV)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
measure: changes in cardiac output (CO)
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.
Other outcomes:
measure: changes in PASS, Postural Assessment Scale for Stroke Patients
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
measure: changes in TIS, Trunk Impairment Scale
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
measure: changes in MI, Motricity Index
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
measure: changes in RNLI, Reintegration to Normal Living Index
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
measure: changes in MBI, Modified Barthel Index
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
measure: changes in HADS, Hospital Anxiety and Depression Scale
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
measure: MoCA, Montreal Cognitive Assessment
timeFrame: All participants will be assessed at baseline (during the evaluation).
measure: BMI, Body Mass Index
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
measure: changes in walking endurance and capacity
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
measure: changes in walking speed, joint motion, and muscle activation
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
measure: Modified Functional Reach Test
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
measure: Fugl Meyer Lower Extremity
timeFrame: All participants will be assessed at baseline (during the evaluation) and at the end of the 8-week intervention.]
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Wen Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: