Using a robotic Ekso device to improve walking and balance in Parkinson's disease

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

This will test whether twice-weekly Ekso robotic exoskeleton training for eight weeks helps people with Parkinson's improve walking, balance, and quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Albert Einstein Healthcare Network (other)
• Locations: 1 site (Elkins Park, Pennsylvania)
• Trial ID: NCT06225830 on ClinicalTrials.gov

What this trial studies

The study will enroll up to 24 adults with physician-diagnosed idiopathic Parkinson's disease and self-reported gait or balance impairment across Hoehn and Yahr stages 1–4. Participants will receive two 60-minute Ekso robotic gait-training sessions per week for eight weeks, with each session divided into setup, three 15-minute training segments, and a wrap-up, and intensity targeted to RPE 14–17 for 30 minutes. Ekso assistance, trajectories, and optional resistance will be adjusted session-to-session to progressively reduce support as participants improve or to accommodate fatigue or weakness. Walking, balance, and quality-of-life outcome measures will be collected at baseline, mid-program, end of treatment, and at a three-month follow-up.

Who should consider this trial

Good fit: Ideal candidates are adults with physician-diagnosed idiopathic Parkinson's (Hoehn & Yahr stages 1–4) who report walking or balance problems, can tolerate standing and higher-intensity gait training, and meet the device weight and height limits.

Not a fit: Patients with other concurrent neurological disorders, significant leg length discrepancy, those currently in another interventional therapy or unable to tolerate upright/high-intensity training, or who exceed the device's weight/height limits are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, this approach could improve walking speed, balance, and day-to-day mobility, leading to better quality of life for people with Parkinson's.

How similar studies have performed: Small prior trials of robotic exoskeleton or intensive gait training in Parkinson's have shown promising improvements in gait and balance, but larger definitive trials are limited.

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

Where this trial is running

Elkins Park, Pennsylvania

• Jefferson Moss-Magee Rehabilitation - Elkins Park — Elkins Park, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Jacqueline Brown, DPT — Albert Einstein Healthcare Network
• Study coordinator: Jacqueline Brown, DPT

Conditions: Parkinson Disease