Clinical trial NCT04877249: Gait Training in Post-Stroke Hemiparesis Hemiparesis
Official title: Gait Training to Reduce Compensatory Walking Patterns in Post-Stroke Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hemiparesis
Split-belt treadmill
gait training
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The focus of this study is to optimize the delivery of a combined strength and aerobic training regimen to individuals with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. This study proposes to use 1) split-belt treadmill and 2) single belt treadmill walking using split belt simulation software for enhancing symmetrical walking patterns for people with stroke.

Detailed description: This study will include twenty stroke survivors and twenty healthy adults (total 40 participants) who are 20 years or older. Both groups (stroke vs healthy) will be screened and recruited from a UTMB Stroke Support Group and local community in Galveston or Harris County for one year (2021-22). Healthy individuals will also participate in gait training compared to stroke participants. The focus of this gait training is to optimize the delivery of a combined strength and aerobic training regimen to older adults with post stroke hemiparesis and reduce overuse and inefficiencies associated with the nonparetic leg during walking. Investigators propose to use a combination of neuromechanical and biobehavioral approaches to enhance bilateral symmetry of limb propulsion using specialized split-belt, force-plate instrumented treadmill that uses backward directed resistance forces. With neuromechanics investigators will measure joint torque output, EMG muscle activity patterns, and trailing limb angle, while a person is walking under normal treadmill belt conditions versus the split-belt conditions at different levels of resistance. Electromyography (EMG) detects electrical activity during muscle contraction while the single or the split-belt treadmill walking. The joint torque output and trailing limb angle can be obtained by using the Vicon Motion System (Vicon, Oxford, UK) in conjunction with the Bertec split-belt, force plates instrumented treadmill (Bertec Corp., Columbus, OH). In addition, in terms of biobehavioral metrics, investigators will measure the extent to which people maintain improved paretic limb propulsion contributions immediately after the split-belt environment is restored to a single belt condition (i.e. aftereffects), and the ability of individuals to consciously alter their walking pattern so as to reduce compensatory walking patterns when they are not engaged with the specialized treadmill setup.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals, ages 20 or older
* Healthy participants will be required to be medically stable
* Healthy participants are able to walk at least 10 meters independently at a comfortable speed without an assistive device
* The participants with a history stroke, ages 20 or older
* Unilateral first stroke of ischemic origin in the carotid artery distribution
* Unilateral first stroke of hemorrhagic origin in the carotid artery distribution
* Diagnosis of stroke at least 6 months prior to participation
* Free of major post-stroke complications (e.g., recurrent stroke, hip fracture, myocardial infarction)
* Living within the community
* The participants with a history stroke are able to ambulate 10 meters with or without assistive devices

Exclusion Criteria:

* A history of any significant orthopedic problems
* A history of psychiatric or cognitive illness (e.g., bipolar affective disorder, psychosis, schizophrenia, attention deficits, cognitive deficits, or medication refractor depression)
* Neurological problems
* Stroke secondary to subarachnoid hemorrhage or posterior circulation stroke
* Not expected to live more than one year
* Comatose
* Unable to follow 3 step commands
* Amputation
* Poorly controlled diabetes (e.g., foot ulceration)
* Blind
* Progressive neurological diseases
* Comprehensive aphasia
* Medical instability
* Significant musculoskeletal problems
* Congestive cardiac failure
* Unstable angina
* Peripheral vascular disease
* Neuropsychiatric disorders (e.g., dementia, cognitive deficits, and severe depression)

Primary outcomes:
measure: Bilateral symmetry of ground reaction forces during split-belt treadmill walking
timeFrame: Single point of assessment in one day and ground reaction forces will be recorded continuously for 20-30minutes and will be expressed per gait cycle
measure: Bilateral symmetry of joint torques during split-belt treadmill walking
timeFrame: Single point of assessment in one day and joint torques will be recorded continuously for 20-30minutes and will be expressed per gait cycle
measure: Trailing limb angle during split-belt treadmill walking
timeFrame: Single point of assessment in one day and trailing limb angle will be recorded continuously for 20-30minutes and will be expressed per gait cycle
measure: Bilateral muscles activities during split-belt treadmill walking
timeFrame: Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle
measure: Bilateral muscles activities during split-belt treadmill walking
timeFrame: Single point of assessment in one day and muscle activity will be recorded continuously for 20-30minutes and will be expressed per gait cycle
measure: Spatiotemporal patterns during split-belt treadmill walking
timeFrame: Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.
measure: Spatiotemporal patterns during split-belt treadmill walking
timeFrame: Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.
measure: Spatiotemporal patterns during split-belt treadmill walking
timeFrame: Single point of assessment in one day and spatiotemporal gait parameters will be recorded continuously for 20-30minutes and will be expressed per gait cycle.
Secondary outcomes:
measure: Spatiotemporal patterns of overground walking
timeFrame: Baseline assessment before split/tied treadmill walking
measure: Spatiotemporal patterns of overground walking
timeFrame: Baseline assessment before split/tied treadmill walking
measure: Spatiotemporal patterns of overground walking
timeFrame: Baseline assessment before split/tied treadmill walking
measure: Spatiotemporal patterns of overground walking
timeFrame: Baseline assessment before split/tied treadmill walking
measure: Kinematic representation of the temporal events during standing and walking
timeFrame: Baseline assessment before split/tied treadmill walking
measure: Kinematic representation of the temporal events during standing and walking
timeFrame: Baseline assessment before split/tied treadmill walking
Other outcomes:
Locations:
city: Galveston
country: United States
facility: School of Health Profession, University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Mansoo Ko, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: