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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Einstein Healthcare Network

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Ekso mediated gait trainingExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
2

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.

Time frame
Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
3

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.

Time frame
Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
4

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.

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

Other outcomes

1

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.

Time frame
8 weeks

Sponsors and contacts

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Albert Einstein Healthcare Network

Lead sponsor

Thomas Jefferson University

Sponsor institution

Moss Rehabilitation Research Institute

Collaborator