Robotic Exoskeleton for Parkinson's Disease

Overseen By Kris Ferrara, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein Healthcare Network

Disqualifiers: Neurological disease, Pregnancy, Cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to see how well therapy with the Eksobionic Exoskeleton (Esko) works for people with Parkinson's disease (PWPD). Esko is a robotic device that provides high repetition and intensity training. The investigators will examine its impact on walking, balance, and quality of life before, during and after an eight-week intervention program. The results will lay the groundwork for future trials, potentially leading to long-term improvements in mobility and quality of life for PWPD.

Who Is on the Research Team?

Jacqueline Brown, DPT

Principal Investigator

Albert Einstein Healthcare Network

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who are looking to improve their walking, balance, and quality of life. Specific eligibility criteria have not been provided.

Inclusion Criteria

I have trouble walking or keeping my balance.

I agree to do 45-60 minutes of intense walking exercise.

I am over 18 years old.

Exclusion Criteria

I experience severe muscle or bone pain.

I am not currently participating in any other clinical trials or undergoing physical therapy.

I have an ongoing deep vein clot.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Initial assessment to evaluate baseline gait, balance, and quality of life

1 week

1 visit (in-person)

Treatment

Participants receive Ekso-mediated gait training twice per week for eight weeks

8 weeks

16 visits (in-person)

Re-evaluation

Re-evaluation of gait, balance, and quality of life after 5 weeks of treatment

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Eksobionics Eksoskeleton

Trial Overview The study tests the Eksobionic Exoskeleton (Esko), a robotic device designed to assist in high repetition and intensity training, over an eight-week program to see if it can enhance mobility for people with Parkinson's.

How Is the Trial Designed?

Group I: Ekso mediated gait training Experimental Treatment 1 Intervention

Ekso mediated gait training will take place twice per week for 8 weeks . An Ekso Robotic Eksoskeleton will be used during each treatment session; this device can physically assist leg movements along a customized path or resist or amplify movements the participant makes. Each session will be 60 minutes and will be 3 rounds of 15 minutes of Ekso mediated gait training. Four (4) study related Assessment sessions will be conducted and include a series of physical tests and a written questionnaire. This will be done at the Evaluation/ 1st visit, then the re-evaluation at visit 9, at discharge or visit 17, and finally at a 3-month follow-up.

Who Is Running the Clinical Trial?

Albert Einstein Healthcare Network

Lead Sponsor

Trials

65

Recruited

869,000+

Moss Rehabilitation Research Institute

Collaborator

Trials

12

Recruited

10,100+