Clinical trial NCT06008743: Model-informed Patient-specific Rehabilitation Using Robotics and Neuromuscular Modeling
Official title: Model-informed Patient-specific Rehabilitation Using Robotics and Neuromuscular Modeling
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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:

* Any neurological conditions (applicable to Group A - healthy subjects) or other neurological conditions in addition to stroke (applicable to Group B - stroke survivors);
* Inability to walk outside the home before the stroke (applicable to Group B - stroke survivors);
* Coronary artery bypass graft in the past 3 months, myocardial infarction in the past 3 months, uncontrolled or untreated atrial fibrillation, severe or painful peripheral vascular disease, diagnosis of heart failure, or unstable or untreated angina;
* Expressive aphasia
* Reported musculoskeletal pain or conditions that limit walking (such as tendonitis, arthritis, osteoporosis, spinal stenosis, or any orthopedic surgery or fracture to the legs or spine in the last 6 months);
* Inability to communicate with investigators (e.g., due to severe aphasia or other cognitive impairment);
* Severe respiratory problems such as chronic obstructive pulmonary disease (COPD);
* Unexplained dizziness;
* Weight greater than 250 pounds (lbs).
* Inability to ascend and descend 4 steps with handrails using another person's assistance (if desired)

Primary outcomes:
measure: Contralateral plantarflexor muscle activation during exposure to belt accelerations
timeFrame: During intervention
measure: Contralateral plantarflexor muscle activation during exposure to combined exposure to belt accelerations and exoskeleton interaction
timeFrame: During intervention
measure: Contralateral plantarflexor muscle activation during exposure to lowered stiffness step perturbation
timeFrame: During intervention
measure: Hip extension exposure to belt accelerations
timeFrame: During intervention
measure: Hip extension during exposure to combined exposure to belt accelerations and exoskeleton interaction
timeFrame: During intervention
measure: Hip extension during exposure to lowered stiffness step perturbation
timeFrame: During intervention
measure: Step length symmetry exposure to belt accelerations
timeFrame: During intervention
measure: Step length symmetry during exposure to combined exposure to belt accelerations and exoskeleton interaction
timeFrame: During intervention
measure: Step length symmetry during exposure to lowered stiffness step perturbation
timeFrame: During intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References:
citation: Chambers V, Artemiadis P. Using robot-assisted stiffness perturbations to evoke aftereffects useful to post-stroke gait rehabilitation. Front Robot AI. 2023 Jan 4;9:1073746. doi: 10.3389/frobt.2022.1073746. eCollection 2022.