RecruitingNot ApplicableNCT06225830

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

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

Sponsor

Albert Einstein Healthcare Network

Enrollment

24 participants

Start Date

Jun 4, 2024

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

Physician diagnosed idiopathic Parkinson's disease
All Hoehn and Yahr (H\&Y) stages will be eligible for inclusion in the study
Able to consent to participation in the research study
Pt agreeable to participate in 45-60 minutes of high intensity (RPE 14-17 for 30 minutes) gait training/ physical therapy.
Sufficient upper extremity strength to use a front wheeled walker
Pt to have self- reported walking/balance deficits
Age: Over age 18
Must be able to tolerate at least 15 min upright
Weigh 220 pounds (100kg) or less
Approximately between 5'0" and 6'4" tall
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 Criteria16

Currently involved in another intervention study or physical therapy course of care
Concurrent neurological disease
Leg length discrepancy, self-reported.
Spinal instability
Unresolved deep vein thrombosis
Severe muscular or skeletal pain
Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness
Pregnancy
Cognitive impairments - unable to follow 2 steps commands and communicate for pain or to stop session
Participant requires the assistance of more than one therapist to transfer safely.
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
Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities
Colostomy
History of long bone fractures secondary to osteoporosis
Unable to sustain current medication regimen. Participant reports change in Parkinson's Medication in the past week.
Any reason the therapist may deem as harmful to the participant to enroll or continue in the study

Interventions

DEVICEEksobionics 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.