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RECRUITING

NCT06225830

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

Sponsor: Albert Einstein Healthcare Network

View on ClinicalTrials.gov

Summary

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.

Official title: Utilization of Robotic EksoSkeleton to Achieve High Dosing, Intensity, and Complexity of Gait in Treatment of People With Parkinson's Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06-04

Completion Date

2026-06

Last Updated

2025-07-10

Healthy Volunteers

Conditions

Parkinson Disease

Interventions

DEVICE

Eksobionics Eksoskeleton NR

During treatment sessions, the therapist will guide the participant's progress using a specific plan. The therapist will set a trajectory for each leg, determining the appropriate step height and length, and program it into the Ekso device. The Ekso will then assist the participant by following this trajectory, with varying levels of assistance for each step. As the participant improves, the therapist will gradually reduce the assistance provided until the participant reaches a point where they no longer require assistance or reach a plateau. In the final phase, the trajectory will be removed, and the participant will walk using their own movements. The therapist may add resistance or assistance based on the participant's needs, but it will be in line with their self-generated movements rather than a predetermined path.

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

Locations (1)

Jefferson Moss-Magee Rehabilitation - Elkins Park

Elkins Park, Pennsylvania, United States