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

NCT06225830 | Recruiting FDA Device

• 1 other identifier: iRISID-2023-2217
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Steps per session & progression through protocol

  Our goal is to determine the number of steps per session that can be achieved and the rate of progression through various Ekso modes while applying a standardized treatment protocol during Ekso mediated treatment in PwPD. We establish a treatment protocol for use of the Ekso with PwPD, involving two 45-60-minute sessions per week for eight weeks. We hypothesize that under this protocol, participants will achieve \>300 steps per session by the 3rd session and will be able to progress through a series of increasingly challenging training modes by meeting target goals. We will measure the number of sessions required to progress through each step of the training program.

  8 weeks

Secondary Outcomes (6)

• Gait speed-10MWT

  Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)

• Gait endurance- 6MWT

  Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)

• Dynamic balance

  Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)

• Functional strength- 5xSTS

  Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)

• Quality of Life- WHOQOL-BREF

  Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)

Other Outcomes (1)

• Intensity achieved

  8 weeks

Study Arms (1)

Ekso mediated gait training

EXPERIMENTAL

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.

Device: Eksobionics Eksoskeleton NR

Interventions

Eksobionics Eksoskeleton NR DEVICE

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.

Ekso mediated gait training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosed idiopathic Parkinson's disease
• 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?"

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• Moss Rehabilitation Research Institute: collaborator

Study Sites (1)

Jefferson Moss-Magee Rehabilitation - Elkins Park

Elkins Park, Pennsylvania, 19027, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jacqueline Brown, DPT

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Brown, DPT

CONTACT

215-663-6575; Jxb892@jefferson.edu

Kris Ferrara, DPT

CONTACT

215-663-6575; Kristopher.Ferrara@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physical Therapist, Jefferson Moss Magee Rehabilitation

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 26, 2024
• Study Start: June 4, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Relevant information will be available with publication of study results.
• Access Criteria: Primary investigator will respond to reasonable requests in the interim.

Locations

US (1)