About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Currently involved in another intervention study or physical therapy course of care
Concurrent neurological disease
Leg length discrepancy, self-reported.
Spinal instability
Trial design
Single group
Treatments tested in this trial
Eksobionics Eksoskeleton NR
DeviceDuring 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Gait speed-10MWT
Another goal is to determine the effect of Ekso facilitated training on gait speed in PwPD. It is hypothesized that benefits will be seen in the 10 Meter Walk Test (10MWT) noted by improvements in gait speed measured in meters per second.
Gait endurance- 6MWT
Another goal is to determine the effect of Ekso facilitated training on gait endurance in PwPD It is hypothesized that benefits will be seen in the six-minute walk test (6MWT) noted by improvements in gait endurance. This will be measured in change in meters walked during the six minute walk test.
Dynamic balance
Another goal is to determine the effect of Ekso facilitated training on dynamic balance in PwPD. It is hypothesized that benefits will be seen in the Functional Gait Assessment (FGA) noted by improvements in dynamic balance. The FGA is measured on an ordinal scale ranging from 0 to 30.
Functional strength- 5xSTS
Another goal is to determine the effect of Ekso facilitated training on functional strength in PwPD. It is hypothesized that benefits will be seen in the Five time sit to stand (5xSTS) assessment noted by improvements in functional strength. This will be measured by time in seconds.
Other outcomes
Intensity achieved
Another goal is to determine the activity intensity level achieved by PwPD using a standardized Ekso-mediated treatment protocol. Intensity is essential for functional change. It is unknown what level of intensity is achieved with the Ekso during treatment of PwPD. We hypothesize that treatment utilizing the Ekso achieves high intensity. For the study we will define high intensity by 14-17/20 Borg Rating of Perceived Exertion (RPE) or target heart rate (HR) 70-85% HR max for at least 30 minutes per session for at least 11 out of 15 therapy sessions. During sessions, HR will be monitored continuously and RPE will be recorded at 15-minute intervals.
Sponsors and contacts
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Albert Einstein Healthcare Network
Lead sponsor
Thomas Jefferson University
Sponsor institution
Moss Rehabilitation Research Institute
Collaborator