NCT06225830

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will enroll up to 24 participants with idiopathic Parkinson's disease (PD) and gait or balance impairment, ranging from Hoehn and Yahr stage 1-4. The overall study design consists of an initial assessment followed by physical therapy treatment utilizing the Ekso robotic device. The treatment will take place two times per week for eight weeks, with outcome measures performed during the evaluation, re-evaluation on visit 9, last session, and on a 3 month follow up. Each treatment session will last 60 minutes, divided into set-up, three 15-minute segments, and a wrap-up. Throughout the treatment sessions, Ekso settings will be adjusted as the patient progresses or fatigues with the device providing optimal levels of support. In brief, each session will begin by establishing an appropriate trajectory or path for each leg, programmed into the Ekso. The Ekso skeleton will assist the participant through this trajectory, gradually reducing assistance as the participant improves. A ceiling for the maximal level of assistance will be set once the participant requires less than 70% assistance on their best step. As the participant progresses and reaches set goals, the trajectory will be removed, and the participant will walk with self-generated movement. The therapist may add resistance or assistance in the direction of the participant's self-generated movement, depending on the patient's fatigue or weakness. Intensity assessment, as outlined in Aim 2, will involve the utilization of the Rating of Perceived Exertion (RPE) scale and continuous monitoring of the participant's heart rate (HR). The participant will provide an RPE score at the end of each 15-minute segment to indicate the perceived challenge level. HR will be continuously monitored using a Polar arm HR monitor and app, documenting the duration of time spent within different HR zones. As is typical practice in physical therapy, sessions will be interrupted or discontinued if the patient is unable to tolerate further treatment as assessed by the physical therapist. To evaluate the effects of Ekso-facilitated training on various outcome measures, as stated in Aim 3, several assessments will be performed. These include the 10-Meter Walk Test (10MWT) and 6-Minute Walk Test (6MWT) for gait speed and endurance, the Functional Gait Assessment (FGA) and Timed Up and Go (TUG) for balance and fall risk, the 5 Times Sit-to-Stand (5xSTS) for functional strength and power, and the WHOQOL-BREF questionnaire for quality of life. The time of the last dose of Parkinson's medications will also be noted during each assessment. The research design and procedures involve a structured treatment protocol utilizing the Ekso, intensity assessment through RPE and HR monitoring, and evaluation of various outcome measures related to gait, balance, strength, and quality of life. This comprehensive approach aims to investigate the effects of Ekso-mediated treatment on functional changes and provide valuable insights into the potential benefits for individuals with Parkinson's disease. The project endpoints will be reached when all the data required for the study has been collected. However, the study may be terminated prematurely if it is found that over 50% of the participants are unable to tolerate the device or the intensity of the treatment. All participants are fully informed of their right to withdraw from the study at any time if the participant chooses. Participants may also be withdrawn from the study if the participant displays inconsistent attendance to therapy sessions or are unable to tolerate the required level of exercise as indicated by the Rating of Perceived Exertion (RPE). Additionally, any significant changes in the participant's medical status will result in their withdrawal. The anticipated risks associated with the study are minimal and include fatigue and frustration. Participants experiencing fatigue or frustration will be instructed to take rest breaks as needed. Another potential risk is discomfort during movement assistance. Participants will be encouraged to communicate any areas of discomfort to the therapist, and appropriate modification will be made to the device. Regarding the risk of loss of confidentiality, precautions will be implemented to ensure the appropriate collection, management, and storage of personal data. These measures are put in place to minimize the risk of unauthorized access or disclosure of participant information. There are no additional known social, legal, or economic risks associated with participation in these studies, further ensuring the safety and well-being of the participants.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-04
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-01-26
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study