Robotic Gait Training for Parkinson's Disease

Overseen By Peter Altenburger, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Severe dyskinesia, Unstable medication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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. 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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your Parkinson's medication has been stable for the past 3 months.

What data supports the effectiveness of the treatment Robotic Gait Training for Parkinson's Disease?

Research shows that robot-assisted gait training can improve certain aspects of walking in people with Parkinson's disease, such as hip movement, compared to traditional treadmill training. This suggests that robotic gait training may be effective in enhancing walking abilities in these patients. ^{1 2 3 4 5}

Is robotic gait training generally safe for humans?

Robotic gait training is generally safe, but it can cause some side effects like skin and tissue discomfort, musculoskeletal issues, and changes in blood pressure. These issues are often related to the pressure and alignment between the robot and the person using it. ^{1 6 7 8 9}

How is the G-EO End-Effector Gait Trainer treatment different from other treatments for Parkinson's disease?

The G-EO End-Effector Gait Trainer is unique because it uses robotic technology to assist with walking, helping to improve movement patterns by targeting both the mechanics and the nervous system involved in walking. This approach is different from traditional physical therapy as it combines robotic assistance with real-world training, potentially offering more effective rehabilitation for gait issues in Parkinson's disease. ^{1 3 4 5 10}

Eligibility Criteria

This trial is for adults over 18 with Parkinson's Disease at stages 1-3, who've been stable on their current medication for the last three months. They must have a Mini Mental State Exam score above 24 and physician approval to exercise. Those with severe movement issues or recent physical therapy are excluded.

Inclusion Criteria

My Parkinson's disease is in the early to mid-stage.

I have been diagnosed with Parkinson's Disease.

You scored higher than 24 on the Mini Mental State Examination.

Exclusion Criteria

I do not have conditions like bone instability that prevent G-EO gait training.

You weigh more than 150 kilograms.

You are shorter than 1 meter or taller than 2 meters.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo electromechanically-assisted gait training using the G-EO System, administered 2 times per week for 40-60 minutes over six weeks

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of walking speed, balance, and quality of life

4 weeks

Treatment Details

Interventions

• Conventional Physical Therapy Treatment
• G-EO End-Effector Gait Trainer
• Robotic Gait Rehabilitation

Trial Overview The study tests a new robotic gait training system (G-EO System) against conventional physical therapy to see if it improves walking, function, and quality of life in Parkinson's patients. Participants will be randomly assigned to one of the treatments without knowing which one they're getting.

Participant Groups

Group I: Conventional Physical Therapy (CPT) Group with G-EO Training (CPT-GEO) Experimental Treatment 2 Interventions

CPT-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.

Group II: Conventional Physical Therapy (CPT) Group Active Control 1 Intervention

CPT 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.

G-EO End-Effector Gait Trainer is already approved in Switzerland, European Union for the following indications:

Approved in Switzerland as G-EO System for:

• Neurological rehabilitation
• Orthopedic rehabilitation
• Gait disorders in Parkinson's disease

Approved in European Union as G-EO System for:

• Neurological rehabilitation
• Orthopedic rehabilitation
• Gait disorders in Parkinson's disease

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Findings from Research

Robot-assisted gait therapy using the Lokomat system showed positive effects on gait parameters in a 67-year-old female with Parkinson's disease, including increased gait speed, stride length, and improved foot clearance after six training sessions.

The therapy also led to improvements in various aspects of the Unified Parkinson's Disease Rating Scale, such as motivation and bradykinesia, indicating potential benefits for overall mobility and quality of life, though more research is needed to compare its efficacy against traditional training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of robotic locomotor training in an individual with Parkinson's disease: a case report. Ustinova, K., Chernikova, L., Bilimenko, A., et al.[2011]

In a study involving 50 patients with Parkinson's disease, end-effector robotic rehabilitation training showed significant improvements in specific gait variables, indicating enhanced gait kinematics.

In contrast, intensive treadmill training did not result in any statistically significant changes in walking performance, suggesting that robotic therapy may be more effective for rehabilitation in mild Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training versus treadmill training in patients with Parkinson's disease: a kinematic evaluation with gait profile score. Galli, M., Cimolin, V., De Pandis, MF., et al.[2019]

The study will compare the effects of functional kinematic therapy and overground wearable exoskeleton training on gait in 50 participants with Parkinson's Disease, evaluating changes in both peripheral and central nervous system function over three time points.

By integrating comprehensive gait analysis with neuromusculoskeletal modeling and brain activity assessments, the research aims to provide personalized treatment strategies for managing gait and postural disorders in Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative assessment of training effects using EksoGT® exoskeleton in Parkinson's disease patients: A randomized single blind clinical trial. Romanato, M., Spolaor, F., Beretta, C., et al.[2022]

Robot-assisted gait training, especially when combined with motivational instructions from a therapist, significantly increases muscle activity in children with motor impairments compared to training without instructions.

The study found that robotic-assisted gait training can produce more physiological muscle activation patterns than unassisted treadmill walking, suggesting it may promote restorative mechanisms in movement rather than just compensatory ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leg surface electromyography patterns in children with neuro-orthopedic disorders walking on a treadmill unassisted and assisted by a robot with and without encouragement. Aurich Schuler, T., Müller, R., van Hedel, HJ.[2021]

Robot-assisted gait training (RAGT) significantly improves motor function and balance in patients with Parkinson's disease, as shown in a meta-analysis of 14 randomized controlled trials involving 572 participants.

Compared to conventional training, RAGT led to notable improvements in various motor function assessments, including the 10-Meter Walk Test (10MWT), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), and the Unified Parkinson's Disease Rating Scale (UPDRS III).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of rehabilitation robot-assisted gait training on lower extremity dyskinesia in patients with Parkinson's disease: A systematic review and meta-analysis. Xue, X., Yang, X., Deng, Z.[2023]

The G-EO Systems gait robot allows for intensive practice of various walking patterns, showing that its adaptive training mode produces ground reaction forces similar to real walking, which is crucial for effective rehabilitation.

The adaptive control strategy of the gait robot improves the timing of force interactions compared to passive mode, suggesting it may be a promising approach for treating gait disorders, pending further clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive locomotor training on an end-effector gait robot: evaluation of the ground reaction forces in different training conditions. Tomelleri, C., Waldner, A., Werner, C., et al.[2013]

End-effector Robot-Assisted Gait Training (RAGT) significantly improved body function and reduced spasticity in 26 subacute stroke patients compared to conventional gait training, as shown by various clinical assessments and the 6-Minute Walk Test (6MWT).

While both RAGT and conventional gait training led to positive outcomes, RAGT provided more intensive and controlled training, resulting in greater improvements in mobility and participation scales, highlighting its potential as a superior rehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of end-effector Robot-Assisted Gait Training in subacute stroke patients: Clinical and gait outcomes from a pilot bi-centre study. Aprile, I., Iacovelli, C., Goffredo, M., et al.[2020]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

The Gait Exercise Assist Robot (GEAR) significantly improved abnormal gait patterns in chronic stroke patients, showing marked reductions in hip hiking and excessive hip external rotation after 20 training sessions compared to baseline measurements.

Participants in the GEAR group reported greater improvements in their overall gait perception, as indicated by higher Global Rating of Change (GRC) scores at multiple follow-up assessments, suggesting that GEAR training may be more effective than traditional treadmill training for enhancing gait in chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial. Ogino, T., Kanata, Y., Uegaki, R., et al.[2021]

In a study involving 60 patients with mild to moderate Parkinson's disease, robotic gait training and treadmill training showed similar improvements in walking ability, with no significant difference between the two methods after treatment.

Both robotic gait training and treadmill training were more effective than conventional physical therapy in enhancing walking ability, and these improvements were maintained at a 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training versus equal intensity treadmill training in patients with mild to moderate Parkinson's disease: a randomized controlled trial. Picelli, A., Melotti, C., Origano, F., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of robotic locomotor training in an individual with Parkinson's disease: a case report. [2011]

2. Italy pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training versus treadmill training in patients with Parkinson's disease: a kinematic evaluation with gait profile score. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Quantitative assessment of training effects using EksoGT® exoskeleton in Parkinson's disease patients: A randomized single blind clinical trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Leg surface electromyography patterns in children with neuro-orthopedic disorders walking on a treadmill unassisted and assisted by a robot with and without encouragement. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of rehabilitation robot-assisted gait training on lower extremity dyskinesia in patients with Parkinson's disease: A systematic review and meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adaptive locomotor training on an end-effector gait robot: evaluation of the ground reaction forces in different training conditions. [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of end-effector Robot-Assisted Gait Training in subacute stroke patients: Clinical and gait outcomes from a pilot bi-centre study. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training versus equal intensity treadmill training in patients with mild to moderate Parkinson's disease: a randomized controlled trial. [2013]