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?

This trial tests a robotic device called the Eksobionic Exoskeleton to help people with Parkinson's disease improve walking, balance, and quality of life. Participants will use the exoskeleton in a guided exercise program for eight weeks. The study aims to determine if the device can make everyday movements easier and more stable. Individuals with Parkinson's disease who experience walking or balance issues and are comfortable using a walker might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily living for those with Parkinson's disease.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be able to maintain your current medication regimen without changes.

What prior data suggests that the Eksobionic Exoskeleton is safe for people with Parkinson's disease?

Research shows that the Eksobionic Exoskeleton (Esko) is generally safe for people with Parkinson's disease. Studies have found that wearable robotic exoskeletons like Esko can assist with walking and balance. Users of these devices have not encountered major safety issues.

The exoskeleton guides the legs along a set path and adjusts to the user's movements. It aims to enhance mobility without causing harm. While no treatment is completely risk-free, evidence so far suggests that Esko is well-tolerated. Prospective trial participants may find this information reassuring regarding the device's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Eksobionics Eksoskeleton is unique because it offers a new, high-tech approach to managing Parkinson's disease symptoms, focusing on mobility and gait training. Unlike standard treatments like medication or physical therapy, this robotic exoskeleton physically assists or enhances leg movements, tailoring support to the user's needs. Researchers are excited about this treatment because it could improve walking ability more effectively by combining physical support with personalized movement training, potentially leading to better quality of life for patients with Parkinson's.

What evidence suggests that the Eksobionics Exoskeleton is effective for Parkinson's disease?

Research suggests that robotic exoskeletons, such as the Eksobionic Exoskeleton, could benefit people with Parkinson's disease. In this trial, participants will undergo Ekso-mediated gait training using the Eksobionic Exoskeleton. Studies have shown that these devices may improve memory and walking endurance. One study found that exoskeletons might aid in standing balance recovery. However, the evidence remains uncertain, and further research is needed to confirm these benefits. Overall, early findings suggest that robotic exoskeletons might enhance mobility and quality of life for people with Parkinson’s. ^{1 5 6 7 8}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06225830

Unlocking Movement Potential: Enhancing Parkinson's ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39666104

Effectiveness of robot-assisted training in adults with ... Our results show that the evidence is very uncertain about the effectiveness of any kind of RAT, either focused on gait, balance or upper limb impairment.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10019475/

Using gait robotics to improve symptoms of Parkinson's disease CONCLUSIONS. Functional exercise with a low-profile overground exoskeleton showed promising results for improving memory and gait endurance in people with PD ...

4. mdpi.com mdpi.com/1424-8220/24/23/7498

Assisting Standing Balance Recovery for Parkinson's ... Our experiments demonstrated the potential effectiveness of the proposed exoskeleton robot and controller for standing balance recovery control in PD patients.

5. withpower.com withpower.com/trial/phase-parkinson-disease-1-2024-a41bd

Robotic Exoskeleton for Parkinson's Disease 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7199547/

Physiotherapists' Experiences Using the Ekso Bionic ... The purpose of this study was to explore how the training and implementation of using the Ekso robotic exoskeleton with patients affects physiotherapists' work.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9156880/

Quantitative assessment of training effects using EksoGT ... Quantitative assessment of training effects using EksoGT® exoskeleton in Parkinson's disease patients: A randomized single blind clinical trial. M Romanato. M ...

8. synapse.koreamed.org synapse.koreamed.org/articles/1516092323

Wearable Robots for Rehabilitation and Assistance of Gait In patients with Parkinson's disease (PD), wearable robotic exoskeletons are used not only to compensate for muscle weakness and provide ...