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Parkinson DiseaseNCT05218187

Robotic Gait Rehabilitation in Parkinson's Disease

A study testing G-EO End-Effector Gait Trainer and Conventional Physical Therapy Treatment in people with Parkinson Disease and Gait Disorder, Sensorimotor, run by Indiana University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to investigate the implementation of a novel gait rehabilitation stimulus (G-EO System) that could advance current clinical practices. The goal is to establish the safety and feasibility of gait training using the G-EO System as well as investigating the impact on mobility, function… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
G-EO End-Effector Gait Trainer and Conventional Physical Therapy Treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
10 Jan 2022to 22 Aug 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age > 18years
  • Confirmed diagnosis of Parkinson's Disease
  • Hoehn and Yahr stage 1 to 3
  • Stable course of disease-modifying therapy over the past 3 months
  • Mini Mental State Examination > 24
  • Physician approval for exercise
  • Stable deep brain stimulation setting for the past year
  • Demonstrate a need for functional rehabilitation

Who cannot join

  • • Severe dyskinesia or severe on-off phenomenon
  • Unstable medication regiment
  • Any co-morbidity that will interfere with walking
  • Conventional physical therapy or G-EO training within the past 6 months
  • Height <1m or >2m
  • Body weight >150 kg
  • Contraindications to G-EO gait training (e.g., bone instability)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • IU Health Neurorehabilitation and Robotics

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

The purpose of this study is to investigate the implementation of a novel gait rehabilitation stimulus (G-EO System) that could advance current clinical practices. The goal is to establish the safety and feasibility of gait training using the G-EO System as well as investigating the impact on mobility, function, quality of life, and participatory outcomes.

Research Design: We propose a single-blinded, randomized trial of electromechanically-assisted gait training using the G-EO System in patients with Parkinson's disease with gait disability.

Read more

Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System.

Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, function, and quality of life

Read the detailed description

Individuals diagnosed with Parkinson's disease (PD) often suffer from difficulties with gait initiation, maintaining a consistent kinematic gait pattern, and transitions between gait environments. Focused gait training that provides an environment that can emphasize motor control improvement in these deficits would be ideal for building a rehabilitative foundation for gait recovery for individuals with PD.

One approach that has been used to maintain and restore function in other neurological populations with severe disability is gait rehabilitation using treadmill training. This approach allows for specific and repetitive practice of walking movement and can involve therapist or electromechanical assistance. There is preliminary evidence from two small, uncontrolled studies supporting the benefits of therapist-assisted treadmill training on walking, balance, fatigue, spasticity, muscle strength, and quality of life in patients with PPMS and SPMS. Nevertheless, therapist-assisted gait training can require up to three trainers per patient making it burdensome and inefficient in the clinical setting. The intensity of manual treadmill training is low (i.e., <1.5 METs) based in part on the physical capacity and fitness level of the trainers, yet physiological adaptations for optimizing outcomes require moderate or vigorous intensity exercise.

Robotic-assisted gait training (RAGT) addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology AG: Olten, Switzerland) is a novel end-effector robotic gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback. Gait training using the G-EO System has been applied in patients with stroke, Multiple Sclerosis (MS), and cerebral palsy (CP). These studies have established safety and feasibility, and preliminary evidence for benefits on mobility and function. For example, two studies involving 4 weeks of G-EO training with conventional physical therapy in non-ambulatory subacute stroke patients reported improved gait, stair climbing ability, leg strength, and activities of daily living (ADL) compared to physical therapy alone. There is limited RAGT studies evaluating the impact of this type of training for individuals with PD. The potential focus on improved gait kinematics may be of particular benefit for PD patients who often struggle with maintain step length and initiation.

The logistic advantages and advanced training capabilities of the G-EO System, as well as the benefits reported in other populations, support this strategy as an effective rehabilitation tool for restoring and maintaining function in Parkinson's disease. This approach represents an opportunity for improving current clinical practices for patients with Parkinson's disease. If successful, this project will provide initial evidence for increasing patient access to the G-EO System, and this could be accomplished through "regional technology centers" using a rural health-delivery approach.

The purpose of this study is to investigate the implementation of a novel gait rehabilitation stimulus (G-EO System) that could advance current clinical practices. The goal is to establish the safety and feasibility of gait training using the G-EO System as well as investigating the impact on mobility, function, quality of life, and participatory outcomes.

Research Design: We propose a single-blinded, randomized trial of electromechanically-assisted gait training using the G-EO System in patients with Parkinson's disease with gait disability. Enrolled participants will be randomized to either conventional physical therapy (CPT) or CPT with G-EO training. Participants will complete baseline assessments on Day 1 and then be scheduled for the intervention phase of the study. Regardless of group allocation, each participant will receive 12 total visits scheduled ideally for twice a week for 6 weeks. Within one week of completing the 12th physical therapy visit, participants will repeat the outcome assessments (post-intervention timepoint). Participants will then be asked to return 30 days later for a final outcome assessment (one month follow-up timepoint).

Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System.

Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, function, and quality of life.

Being tested
G-EO End-Effector Gait Trainer, Conventional Physical Therapy Treatment
Keywords
End-Effector Gait Training, Robot-Assisted Gait Training, Mobility, Function, Quality of Life
Medical subject headings
Parkinson Disease, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • G-EO End-Effector Gait TrainerDevice

    The G-EO Gait Trainer uses distal fixation to promote a gait recovery by facilitating a controlled walking environment that includes an over-ground pattern and stair climbing. In addition, the device provides body position control to enable the patient to concentrate on the cyclical motion of walking without the fear of falling. Physical therapists can control different parameters of the gait cycle through computerized adjustments and the training setting can be manipulated to engage patients in active participation.

  • Conventional Physical Therapy TreatmentOther

    Therapists will use traditional methods of neurological rehabilitation for improved gait and balance. These approaches will include stretching, strengthening, therapeutic exercises, balance training, and over-ground walking

Study groups in NCT05218187
Study groupRoleWhat they receive
Conventional Physical Therapy (CPT) GroupActive comparatorCPT sessions will involve a warm-up using a cycle ergometer or treadmill walking, stretching, progressive strength training exercises, and balance training. Gait training will be provided using traditional over-ground walking. Additional strategies for home exercises, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Training will be administered 2 times per week for 40-60 minutes for six weeks.
Receives: Other: Conventional Physical Therapy Treatment
Conventional Physical Therapy (CPT) Group with G-EO Training (CPT-GEO)ExperimentalCPT-GEO sessions will involve a warm-up using a cycle ergometer or treadmill walking, stretching, progressive strength training exercises, and balance training. Gait training will be administered using end-effector gait training protocols (G-EO trainer). Training will be administered 2 times per week for 40-60 minutes for six weeks.
Receives: Device: G-EO End-Effector Gait Trainer; Other: Conventional Physical Therapy Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comfortable Walking Speed (CWS)

    Participants will be asked to walk over a 14-foot pressure mat that will capture their comfortable walking speed. Patients will be instructed to walk at their normal comfortable speed. Walking will begin 5 feet prior to the mat so that each individual walks across the mat at a consistent speed. Participants will pass over the mat 2 times and an average speed will be calculated. It will take 5 minutes to complete this test and will be performed first.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

  2. Fast Walking Speed (FWS)

    Participants will be asked to walk over a 14-foot pressure mat that will capture their fast walking speed. Patients will be instructed to walk at their fastest speed while maintaining safe, accurate gait. Walking will begin 5 feet prior to the mat so that each individual walks across the mat at a consistent speed. Participants will pass over the mat 2 times and an average speed will be calculated. It will take 5 minutes to complete this test and will be performed second.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

  3. Six Minute Walk Test (6MWT)

    Participants will be asked to walk for 6 minutes along a 30m track that is a flat surface and obstacle free. Subjects may stop and rest as often as needed. Researchers will record the distance traveled during the six minute time period.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

Secondary outcomes (8)
  1. Six Minute Walk Test Walking Speed (6MWT)

    Average walking speed during the 6-Minute Walk Test was measured in meters per second (m/s). Change from baseline was calculated at post-intervention and one-month follow-up. Positive change scores indicate increased average walking speed and improved performance. This is not a scale score.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

  2. The Five Times Sit to Stand Test

    The test will quantify functional lower extremity strength. It provides insight into the coordination of functional strength for the accomplishment of transitioning from one posture to another. The participant is asked to safely rise from sitting in a chair to standing and then sit back down five times in a row without using their hands. This test will take about 5 minutes to administer.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

  3. Activities-Specific Balance Confidence Scale (ABC)

    The Activities-specific Balance Confidence (ABC) Scale assesses self-reported confidence in maintaining balance while performing activities of daily living. The scale contains 16 items, with each item rated from 0 (no confidence) to 100 (complete confidence). The total ABC score is calculated as the average of the 16 item scores and ranges from 0 to 100. Higher scores indicate greater balance confidence and a better outcome; lower scores indicate less balance confidence and a worse outcome.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

  4. Mini-Balance Evaluation Systems Test (MiniBESTest) - Anticipatory Subscale

    The Mini-Balance Evaluation Systems Test (MiniBESTest) is a performance-based measure of dynamic balance. The Anticipatory subscale assesses anticipatory postural adjustments during functional movement. Item scores are summed to produce a subscale score ranging from 0 to 6 points. Higher scores indicate better balance performance and lower scores indicate greater balance impairment.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

  5. Mini-Balance Evaluation Systems Test (MiniBESTest) - Reactive Postural Control Subscale

    The Mini-Balance Evaluation Systems Test (MiniBESTest) is a performance-based measure of dynamic balance. The Reactive Postural Control subscale assesses the ability to recover balance following an external perturbation; examining the effectiveness of compensatory stepping response. Item scores are summed to produce a subscale score ranging from 0 to 6 points. Higher scores indicate better balance performance and lower scores indicate greater balance impairment.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

  6. Mini-Balance Evaluation Systems Test (MiniBESTest) - Sensory Orientation Subscale

    The Mini-Balance Evaluation Systems Test (MiniBESTest) evaluates an individual's ability to maintain postural stability when sensory information is altered or conflicting. It assesses how effectively a person uses visual, vestibular, and somatosensory inputs to maintain balance under increasingly challenging conditions. Item scores are summed to produce a subscale score ranging from 0 to 6 points. Higher scores indicate better balance performance and lower scores indicate greater balance impairment.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

  7. Mini-Balance Evaluation Systems Test (MiniBESTest) - Dynamic Gait Subscale

    The Mini-Balance Evaluation Systems Test (MiniBESTest) is a performance-based measure of dynamic balance. It evaluates an individual's ability to maintain balance while walking under increasingly complex and functionally relevant conditions. It assesses the capacity to adapt gait when confronted with environmental demands, dual-tasking, changes in speed, head movements, obstacle negotiation, and turning. Item scores are summed to produce a subscale score ranging from 0 to 10 points. Higher scores indicate better balance performance and lower scores indicate greater balance impairment.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

  8. Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Score

    The Parkinson's Disease Questionnaire-39 (PDQ-39) is a 39-item, disease-specific questionnaire assessing health-related quality of life in individuals with Parkinson's disease. It includes eight domains: Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognitions, Communication, and Bodily Discomfort. Each item is scored from 0 to 4, with higher scores indicating greater difficulty. Individual domain scores are calculated by summing item responses, dividing by the maximum possible domain score, and multiplying by 100. Each domain ranges from 0 to 100. The PDQ-39 Summary Index is calculated as the unweighted mean of the eight domain scores and ranges from 0 to 100. Lower scores indicate better health-related quality of life, while higher scores indicate worse health-related quality of life.

    Measured: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start10 Jan 2022
  3. Primary completion22 Aug 2025
  4. Study completion22 Aug 2025

Why it stopped: The PI was no longer able to successfully recruit participants and funding was depleted.

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A convenience sample of 30 persons with Parkinson's Disease will be enrolled for this clinical trial. If found eligible for the study and agree to consent to participate, subjects will be randomized to either conventional physical therapy (CPT) group or CPT with G-EO training using a random numbers generator and concealed allocation.
Masking
Single blind
Who is masked
Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218187
Sponsor's protocol ID
11829
Status last verified
Nov 2026
First submitted
20 Jan 2022
Last updated
5 Nov 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: It is not determined at this time.

Questions about this trial

What is this clinical trial studying?

A study testing G-EO End-Effector Gait Trainer and Conventional Physical Therapy Treatment in people with Parkinson Disease and Gait Disorder, Sensorimotor, run by Indiana University 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Nov 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?

Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comfortable Walking Speed (CWS) (time frame: Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit). The study lists 3 primary outcomes in all. 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 5 Nov 2026.

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