Status:
RECRUITING
Model-informed Patient-specific Rehabilitation Using Robotics and Neuromuscular Modeling
Lead Sponsor:
University of Delaware
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06008743
Start Date
September 21 2022
End Date
June 30 2026
Last Update
August 24 2023
Active Locations (1)
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1
University of Delaware
Newark, Delaware, United States, 19716