An interventional study of Belt Accelerations and Belt accelerations combined with an exoskeleton in Stroke, sponsored by University of Delaware. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by University of Delaware · Not applicable, Interventional, and Basic science
Stroke is the third leading cause of death and the primary cause of long-term disability in the United States, affecting approximately 795,000 people each year. Hemiparesis, or unilateral weakness, is common after stroke and responsible for changes in muscle activation and movement patterns as well as declines in walking speed. It has been shown that increased walking speed directly corresponds to a higher quality of life in older adults and therefore, is often the goal of motor rehabilitation after stroke. However, there is no consensus on the best method for improving walking function after stroke and the results of post-stroke gait studies vary widely across sites and studies. Walking is one of the human's most important functions that serve survival, progress, and interaction. The force between the foot and the walking surface is very important. Although there have been many studies trying to understand this, there is a need for the development of a system that can advance research and provide new functionality. In this work, we will conduct a series of studies that attempt to analyze human gait and adaptations from different perspectives.
University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Two groups of subjects will be included in the study.
Group A: Individuals must be between the ages of 18 and 80 years, be in general good health, and be proficient in English. The subjects' physical fitness for participation in the research procedures will be documented via the Physical Readiness Questionnaire (PAR-Q). Their answers to the PAR-Q will be evaluated by the study team to determine if they are suitable for the study. Individuals should not have significant musculoskeletal conditions (osteoarthritis, joint replacement etc). The subjects' resting heart rate must be between 60-100 beats per minute, while their resting blood pressure between 90/60 to 140/90. The subjects should weigh under 250 pounds (lbs).
Group B: Individuals must be between the ages of 18 and 80 years, speak English, have a single, unilateral, chronic stroke (>6 months post-stroke), confirmed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan. They should be able to walk at a self-selected speed for at least 15 minutes without assistance from another person. They should be able to respond to questions during screening, provide informed consent and fully follow instructions. The subjects' resting heart rate must be between 60-100 beats per minute, while their resting blood pressure between 90/60 to 160/90. The subjects should weigh under 250 pounds (lbs).
Exclusion Criteria:
All subjects (healthy and stroke survivors) participating in the study
Behavioral: Belt Accelerations · Behavioral: Belt accelerations combined with an exoskeleton · Behavioral: Variable Stiffness treadmill
Intervention used in both healthy and stroke survivors. In this mode, participants are walking on a treadmill with two belts with independent speed control. The speed of each belt will increase with constant acceleration during double support, shortly before push-off of the supported leg.
Intervention used in both healthy and stroke survivors. In this mode, participants are walking on a treadmill with two belts with independent speed control, and using a hip exoskeleton. The velocity of each belt will increase with constant acceleration during double support, shortly before push-off of the supported leg. At the same time, they will be interacting with a wearable motion assistive device (i.e., exoskeleton). The exoskeleton will apply forces to the leg to resist hip extension during accelerations, reducing hip extension relative to the values of that participant at baseline.
Intervention used in both healthy and stroke survivors. In this mode, participants are walking on a treadmill with two belts with identical speed control. A variable stiffness mechanism under one belt will change the vertical stiffness of one side of the treadmill for one or multiple steps. The walkers will be informed before stepping on the softer surface on one side, which can be either the left or the right side.
Contralateral plantarflexor muscle activation during exposure to belt accelerations
Magnitude of the neural signal (in millivolts (mV) sent to three muscles during push-off, as explained via surface ElectroMyoGraphic signals, measured during exposure to belt accelerations. Three measurements (one from each relevant muscle) will be considered primary outcome measures.
Time frame: During intervention
Contralateral plantarflexor muscle activation during exposure to combined exposure to belt accelerations and exoskeleton interaction
Magnitude of the neural signal (in millivolts (mV) sent to three muscles during push-off, as explained via surface ElectroMyoGraphic signals, measured during exposure to combined exposure to belt accelerations and exoskeleton interaction. Three measurements (one from each relevant muscle) will be considered primary outcome measures.
Time frame: During intervention
Contralateral plantarflexor muscle activation during exposure to lowered stiffness step perturbation
Magnitude of the neural signal (in millivolts (mV) sent to three muscles during push-off, as explained via surface ElectroMyoGraphic signals, measured during exposure to lowered stiffness step perturbation. Three measurements (one from each relevant muscle) will be considered primary outcome measures.
Time frame: During intervention
Hip extension exposure to belt accelerations
Extension of the leg during push-off, measured as hip extension angle in degrees, during exposure to belt accelerations.
Time frame: During intervention
Hip extension during exposure to combined exposure to belt accelerations and exoskeleton interaction
Extension of the leg during push-off, measured as hip extension angle in degrees, during exposure to combined exposure to belt accelerations and exoskeleton interaction.
Time frame: During intervention
Hip extension during exposure to lowered stiffness step perturbation
Extension of the leg during push-off, measured as hip extension angle in degrees, during exposure to lowered stiffness step perturbation.
Time frame: During intervention
Step length symmetry exposure to belt accelerations
Step length symmetry, measured as a percentage of the left leg step length to the right leg step length, during exposure to belt accelerations.
Time frame: During intervention
Step length symmetry during exposure to combined exposure to belt accelerations and exoskeleton interaction
Step length symmetry, measured as a percentage of the left leg step length to the right leg step length, during exposure to combined exposure to belt accelerations and exoskeleton interaction.
Time frame: During intervention
Step length symmetry during exposure to lowered stiffness step perturbation
Step length symmetry, measured as a percentage of the left leg step length to the right leg step length, during exposure to lowered stiffness step perturbation.
Time frame: During intervention
Plan to share: No — The individual participant data (IPD) will not be shared for confidentiality reasons, as approved by the Institutional Review Board (IRB) of the university.
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