Unlocking Movement Potential: Enhancing Parkinson's Disease Treatment With Robotic EksoSkeleton

Launched by ALBERT EINSTEIN HEALTHCARE NETWORK · Jan 17, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Unlocking Movement Potential" is studying the effects of a robotic device called the Eksobionic Exoskeleton (Esko) on people with Parkinson's disease. The goal is to see how this device can help improve walking, balance, and overall quality of life for individuals living with this condition. Participants will engage in an eight-week program that involves using the Esko for intensive training sessions. Researchers will assess the impact of this therapy before, during, and after the program to determine if it can lead to lasting improvements in mobility.

To be eligible for this trial, participants must be at least 18 years old and have a doctor-diagnosed case of Parkinson's disease. They should be able to tolerate standing for at least 15 minutes and have enough upper body strength to use a walker. Participants should also report difficulties with walking or balance. However, those with certain medical conditions—like severe pain, other neurological diseases, or significant mobility issues—won't be able to take part. If you join the trial, you can expect to attend sessions where you'll use the robotic exoskeleton under the guidance of trained therapists, helping you work on your mobility and balance in a safe environment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Physician diagnosed idiopathic Parkinson's disease
• • 2. All Hoehn and Yahr (H\&Y) stages will be eligible for inclusion in the study
• • 3. Able to consent to participation in the research study
• • 4. Pt agreeable to participate in 45-60 minutes of high intensity (RPE 14-17 for 30 minutes) gait training/ physical therapy.
• • 5. Sufficient upper extremity strength to use a front wheeled walker
• • 6. Pt to have self- reported walking/balance deficits
• • 7. Age: Over age 18
• • 8. Must be able to tolerate at least 15 min upright
• • 9. Weigh 220 pounds (100kg) or less
• • 10. Approximately between 5'0" and 6'4" tall
• • 11. Have near normal range of motion in hips, knees, and ankles "Can you stand up and straighten your knees even for just a second?" or "Can you lay flat and straighten your knees so there is no bend in the knee?"
• Exclusion Criteria:
• • 1. Currently involved in another intervention study or physical therapy course of care
• • 2. Concurrent neurological disease
• • 3. Leg length discrepancy, self-reported.
• • 4. Spinal instability
• • 5. Unresolved deep vein thrombosis
• • 6. Severe muscular or skeletal pain
• • 7. Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness
• • 8. Pregnancy
• • 9. Cognitive impairments - unable to follow 2 steps commands and communicate for pain or to stop session
• • 10. Participant requires the assistance of more than one therapist to transfer safely.
• • 11. Uncontrolled or severe orthostatic hypotension that limits standing tolerance; defined as sustained, symptomatic drops in systolic and diastolic blood pressure when moving from sitting to standing
• • 12. Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities
• • 13. Colostomy
• • 14. History of long bone fractures secondary to osteoporosis
• • 15. Unable to sustain current medication regimen. Participant reports change in Parkinson's Medication in the past week.
• • 16. Any reason the therapist may deem as harmful to the participant to enroll or continue in the study