Parkinson DiseaseNCT06225830
Unlocking Movement Potential: Enhancing Parkinson's Disease Treatment With Robotic EksoSkeleton
A study testing Eksobionics Eksoskeleton NR in people with Parkinson Disease, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Eksobionics Eksoskeleton NR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to 24 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Sufficient upper extremity strength to use a front wheeled walker
- Pt to have self- reported walking/balance deficits
Show all 11Show fewer
- 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?"
Who cannot join
- 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
Show all 16Show fewer
- 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.
- Any reason the therapist may deem as harmful to the participant to enroll or continue in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Moss-Magee Rehabilitation - Elkins Park
Elkins Park, Pennsylvania, 19027
About this study
Official title: Utilization of Robotic EksoSkeleton to Achieve High Dosing, Intensity, and Complexity of Gait in Treatment of People With Parkinson's Disease
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.
Read the 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
- Being tested
- Eksobionics Eksoskeleton NR
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eksobionics Eksoskeleton NRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Eksobionics Eksoskeleton NR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (6)
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.
Measured: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
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.
Measured: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
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.
Measured: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
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.
Measured: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
Quality of Life- WHOQOL-BREF
Another goal is to determine the effect of Ekso facilitated training on quality of Life in PwPD. It is hypothesized that benefits will be seen in the World Health Organization- Quality of Life Brief (WHOQOL-BREF) noted by improvements in the scaled score (recorded in percentage).
Measured: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
Fall risk
Another goal is to determine the effect of Ekso facilitated training on fall risk in PwPD. It is hypothesized that benefits will be seen by decreased risk of falls noted in an improvement in their Timed-up-and-go (TUG) score. This will be assessed by time in seconds
Measured: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start4 Jun 2024
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- Moss Rehabilitation Research Institute
- Responsible party
- Principal investigator, Jacqueline Brown, Thomas Jefferson University
- Investigators
- Jacqueline Brown, DPT, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225830
- Sponsor's protocol ID
- iRISID-2023-2217
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Any individual data will be de-identified and shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Robotic EksoSkeleton to Achieve High Dosing, Intensity, and Complexity of Gait in Treatment of People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06225830
- Acronym / sponsor ID
- iRISID-2023-2217
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- Moss Rehabilitation Research Institute
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ekso mediated gait training | Experimental | Device: Eksobionics Eksoskeleton NREkso 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Sufficient upper extremity strength to use a front wheeled walker
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eksobionics Eksoskeleton NRDuring 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. | Device | Ekso mediated gait training |
Primary outcome
Steps per session & progression through protocol
Time frame: 8 weeks
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.
6 secondary outcomes
Gait speed-10MWT
Time frame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
Gait endurance- 6MWT
Time frame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
Dynamic balance
Time frame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
Functional strength- 5xSTS
Time frame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
Quality of Life- WHOQOL-BREF
Time frame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
Fall risk
Time frame: Baseline, re-evaluation (5 weeks), discharge (8 weeks), follow-up (20 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Any individual data will be de-identified and shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Brown, DPT principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eksobionics Eksoskeleton NR in people with Parkinson Disease, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps per session & progression through protocol (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.