Improve walking via robotic exoskeleton

Trial ID
NCT06225830
Official Title
Utilization of Robotic EksoSkeleton to Achieve High Dosing, Intensity, and Complexity of Gait in Treatment of People With Parkinson's Disease
Goal
Improve walking via robotic exoskeleton
Phase
NA
Status
RECRUITING
Sponsor
Albert Einstein Healthcare Network
Study Type
INTERVENTIONAL
Enrollment
24 participants
Conditions
Parkinson Disease
Interventions
Eksobionics Eksoskeleton NR

Summary For Families

The goal is to improve walking and balance by giving people with Parkinson's much more high-intensity, complex gait practice than they can do safely on their own. The approach uses the Ekso wearable robotic exoskeleton to support and assist hip and leg movements so you can stand and take many more steps at a hard effort, helping retrain walking circuits and build endurance; sessions are 45 to 60 minutes with about 30 minutes at RPE 14 to 17, and the therapy is meant to complement your usual Parkinson's medications. They are enrolling adults over 18 with a physician diagnosis of idiopathic Parkinson's who report walking or balance problems, can tolerate at least 15 minutes upright and use a front-wheeled walker, and who fit device limits (under 220 pounds, roughly 5'0" to 6'4"), while people with major cognitive, neurological, cardiovascular, or musculoskeletal issues that make exoskeleton use unsafe are excluded.

Locations

  • Jefferson Moss-Magee Rehabilitation - Elkins Park, Elkins Park, Pennsylvania, United States

Frequently Asked Questions

What is this trial testing?
This trial is studying Eksobionics Eksoskeleton NR. The goal is to improve walking and balance by giving people with Parkinson's much more high-intensity, complex gait practice than they can do safely on their own. The approach uses the Ekso wearable robotic exoskeleton to support and assist hip and leg movements so you can stand and take many more steps at a hard effort, helping retrain walking circuits and build endurance; sessions are 45 to 60 minutes with about 30 minutes at RPE 14 to 17, and the therapy is meant to complement your usual Parkinson's medications. They are enrolling adults over 18 with a physician diagnosis of idiopathic Parkinson's who report walking or balance problems, can tolerate at least 15 minutes upright and use a front-wheeled walker, and who fit device limits (under 220 pounds, roughly 5'0" to 6'4"), while people with major cognitive, neurological, cardiovascular, or musculoskeletal issues that make exoskeleton use unsafe are excluded.
Who can participate?
Participants must be at least 18 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 2 years.
Will I get the real drug or a placebo?
It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
How often will I need to visit the study site?
Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
Can I leave the trial if I change my mind?
Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
Will travel or parking be reimbursed?
Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
Can my spouse or care partner come with me to visits?
In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.

Related Reading

View on ClinicalTrials.gov