Clinical trial NCT06225830: Unlocking Movement Potential: Enhancing Parkinson's Disease Treatment With Robotic EksoSkeleton
Official title: Utilization of Robotic EksoSkeleton to Achieve High Dosing, Intensity, and Complexity of Gait in Treatment of People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
Collaborators: name: Moss Rehabilitation Research Institute
First posted: 2024-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Steps per session & progression through protocol
timeFrame: 8 weeks
Secondary outcomes:
measure: Gait speed-10MWT
timeFrame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
measure: Gait endurance- 6MWT
timeFrame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
measure: Dynamic balance
timeFrame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
measure: Functional strength- 5xSTS
timeFrame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
measure: Quality of Life- WHOQOL-BREF
timeFrame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
measure: Fall risk
timeFrame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
Other outcomes:
measure: Intensity achieved
timeFrame: 8 weeks
Locations:
city: Elkins Park
country: United States
facility: Jefferson Moss-Magee Rehabilitation - Elkins Park
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Jacqueline Brown, DPT
role: PRINCIPAL_INVESTIGATOR
References: