Personalized rehabilitation for stroke recovery using robotics

Model-informed Patient-specific Rehabilitation Using Robotics and Neuromuscular Modeling

This study tests if using robotics and special techniques can help stroke patients walk better and recover more effectively compared to healthy individuals.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Delaware (other)
• Locations: 1 site (Newark, Delaware)
• Trial ID: NCT06008743 on ClinicalTrials.gov

What this trial studies

This study focuses on improving rehabilitation outcomes for stroke patients by utilizing robotics and neuromuscular modeling. It aims to enhance walking speed and overall mobility through innovative interventions such as belt accelerations and exoskeleton-assisted walking. Participants will be divided into two groups: healthy individuals and those with chronic stroke, to evaluate the effectiveness of these rehabilitation techniques. The study seeks to address the variability in rehabilitation outcomes and establish a more effective approach to post-stroke recovery.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 to 80 who have experienced a chronic stroke more than six months prior and are proficient in English.

Not a fit: Patients with significant musculoskeletal conditions or those who do not meet the health criteria outlined in the study will not benefit.

Why it matters

Potential benefit: If successful, this approach could significantly improve walking function and quality of life for stroke survivors.

How similar studies have performed: While there have been various studies on stroke rehabilitation, this specific approach using robotics and neuromuscular modeling is relatively novel and has not been extensively tested.

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)

Where this trial is running

Newark, Delaware

• University of Delaware — Newark, Delaware, United States (RECRUITING)

Conditions: Stroke