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Scientific evidence
Gondola AMPS enhances your brain connectivity improving your gait impairments

More than 10 clinical studies

At Gondola Medical Technologies, we’re working hard to prove how effective our Gondola AMPS therapy is. We want to make sure the information we provide is fair and unbiased. That’s why we’ve conducted clinical research studies with over 250 people with Parkinson’s disease. The studies have shown that the therapy is safe and effective. People who use the therapy regularly have improved walking speed, better movement, and improved balance.

Gondola AMPS enhances your brain connectivity improving your gait impairments
Gondola AMPS enhances your brain connectivity improving your gait impairments

Scientific Publications

Barbic F, Galli M, Vecchia LD, et al. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson’s disease. J Appl Physiol. 2014;116(5):495-503.

The study investigated the effects of AMPS therapy on gait and cardiovascular autonomic control in Parkinson’s Disease.

For this purpose, Parkinson’s patients had almost the same disease severity. Data were collected before and after 24h from the stimulation.

The results reported an increase of around 8% in gait speed, around 4% in step length, and 35% in rotation speed.

In addition, the study suggested a greater cardiac and vascular sympathetic mo-dulation improvement consistent with a more appropriate response to the ortho-static stimulus.

Galli M, Kleiner A, Gaglione M, et al. Timed Up and Go test and wearable inertial sensor: a new combining tool to assess change in subject with Parkinson’s disease after automated mechanical peripheral stimulation treatment. Int J Eng Innov Technol. 2015;4(11):155-163.

This study aimed to investigate the Gondola AMPS effects on postural instability and falls, two aspects of Parkinson’s Disease that strongly limit patients’ independence in everyday activities.

For this purpose, the patients selected for the trial had nearly the same disease severity.  

The subjects were evaluated in the OFF phase before and after the therapy with the Timed Up and Go (TUG) test, a widely used clinical performance-based fall risk measure. Moreover, throughout the test, this information was integrated with detailed kinematics data collected for each individual through a small inertial sensor placed at the patient’s waist. 

Establishing such high-resolution and multimodal motion analysis was considered one of the study’s primary endpoints and added value to the quality of the clinical data collected. The sophisticated research by Galli et al. revealed that AMPS therapy efficiently improves walking stability and reduces the risk of falls in parkinsonians, even after a single session. In particular, following a two minute-stimulation, patients performed the TUG test faster (the time decreased by 50%).

Furthermore, they improved many kinematic parameters, including the speed of standing up and sitting on a chair and rotation.

Stocchi F, Sale P, Kleiner AFR, et al. Long-term effects of automated mechanical peripheral stimulation on gait patterns of patients with Parkinson’s disease. Int J Rehabil Res. 2015;38(3):238-245.

The participants were characterized by moderate motor impairment and homogeneous disease duration. They were free of peripheral sensory neuropathy or other disorders based on their reported history, symptoms, physical examination, and routine tests. The study did not include patients with liver, kidney, lung, heart disease, diabetes, or other causes of autonomic dysfunction.

The subjects were evaluated five times: before and after the first stimulation, after six treatments (2 each week), 48h, and 10 days after the sixth treatment.

These clinical trial results showed that AMPS could improve the overall clinical condition of PD patients after a single session. At the same time, a marked positive effect on bradykinesia is observed following the therapy. In particular, Gondola AMPS therapy effectively improved walking velocity, increased step and stride length, and, in general, increased walking stability. Furthermore, regular administration every four days of AMPS therapy through the Gondola Medical device was sufficient to improve gait parameters, restore walking rhythmicity, and reduce the risk of falls, with positive effects maintained up to 10 days after the last therapeutic session.

Kleiner A, Galli M, Gaglione M, et al. The Parkinsonian Gait Spatiotemporal Parameters Quantified by a Single Inertial Sensor before and after Automated Mechanical Peripheral Stimulation Treatment. Parkinsons Dis. 2015;2015.

This study aimed to evaluate the immediate effects of Gondola AMPS Therapy on Parkinsonian gait.

All the patients who participated in the study were similar in terms of disease duration. In addition, they were free of peripheral sensory neuropathy and other disorders based on their reported histories, symptoms, physical examinations, and clinical tests. The study did not include patients with liver, kidney, lung, or heart diseases, diabetes, or other causes of autonomic dysfunction.  

During all interventions, PD patients were in the off-medication phase after an overnight withdrawal from all anti-Parkinsonian treatments.

First, Kleiner and colleagues asked each individual to walk at a self-selected speed along a well-defined pathway. During this test, an inertial sensor placed at the patient’s waist was used to record typical spatial-temporal gait parameters and analyzed to assess the baseline starting conditions for each patient. Afterward, the patient underwent AMPS therapy (one session of about 2 minutes) delivered through the Gondola medical device and repeated the walking test to assess the immediate therapy effects. Despite remaining in the OFF-medication state, after AMPS therapy, Parkinsonian patients showed an average improvement of 14.85% in stride length, 14.77% in gait velocity, and 29.91% in gait propulsion. Moreover, analyzing the improvement trend concerning the Disease severity (assessed through the H&Y scale), it appeared evident that the therapy had a greater effect on patients with the most severe clinical conditions.

Quattrocchi CC, De Pandis, Galli M, Stocchi F, et al. Acute Modulation of Brain Connectivity in Parkinson’s Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study. PLOS One. 2015;10(10):e0137977.

While many scientific publications documented the clinical benefits of AMPS therapy on gait, the mechanism through which it affects brain activity has been poorly investigated. Therefore, this study aimed to verify whether a single AMPS session could induce measurable stimulus-specific functional connectivity changes in brain areas known to deteriorate in patients with Parkinson’s Disease.

For this purpose, few patients with idiopathic Parkinson’s Disease underwent brain fMRI immediately before and after placebo or effective Gondola® AMPS. In addition, Resting State Functional Connectivity (RSFC) in the selected brain areas was assessed through an analytical method called seed-ROI-based analysis.

The results showed that effective AMPS, but not placebo stimulation, can change functional brain connectivity in some areas analyzed. In particular, a significant increase in RSFC was observed in the ensemble of brain regions involved in visuospatial integration and processing, sensory-motor integration, and anticipation of body positioning during movements. Despite being preliminary, these data suggest that motor rehabilitation strategies based on AMPS Gondola Therapy might act on motor function by facilitating specific brain compensatory patterns that can partially rescue the gait-related deficits typically associated with Parkinson’s Disease.

Galli M, Vicidomini C, Rozin Kleiner AF, et al. Peripheral neurostimulation breaks the shuffling steps patterns in Parkinsonian gait: A double blind randomized longitudinal study with automated mechanical peripheral stimulation. Eur J Phys Rehabil Med. 2018;54(6):860-865.

All the participants were diagnosed with idiopathic PD, with no other significant neurological, orthopedic, or cognitive problems; aged between 40 and 80; capable of walking, without or with minimal assistance, for 25 feet in pharma OFF..

All PD patients were treated in practically defined OFF conditions, having withdrawn from dopaminergic medication overnight. 

All subjects included in the AMPS and SHAM groups were evaluated via gait analysis (GA) before and after the first treatment session, then after a cycle of 6 stimulations. 

The AMPS therapy increased the gait velocity and the stride length immediately post the first session and after six sessions of Gondola® AMPS. Instead, no differences for the SHAM group were observed for these variables. 

Overall, the study outcomes provide further evidence that AMPS therapy can improve walking impairments in Parkinson’s patients, breaking the shuffling steps pattern that characterizes Parkinson’s gait, and providing better hip, knee, and ankle range of motion. 

Pagnussat AS, Kleiner AFR, Rieder CRM, et al. Plantar stimulation in parkinsonians: From biomarkers to mobility – Randomized-controlled trial. Restor Neurol Neurosci. 2018;36(2):195-205.

The participants in the study were diagnosed with idiopathic Parkinson’s Disease and no other significant neurological, orthopedic, or cognitive problems. They were able to walk 25 feet unassisted or with assistive devices; regular FOG episodes.

The subjects with PD underwent eight sessions of effective or placebo AMPS once every four days. The total experimental period lasted four weeks. 

Patients’ evaluations were taken before and after 8 AMPS treatments. The outcomes showed as the AMPS group reported a higher level of BDNF and lowered cortisol. In contrast, the placebo AMPS did not show any changes. Moreover, in the AMPS group, it was possible to observe a greater improvement in walking parameters, such as speed gait, stride length, and TUG time (TUG – Timed Up and Go – is a test to evaluate a person’s mobility). 

In conclusion, Gondola AMPS may be used as a complementary therapy to induce neuroplasticity and improve gait in subjects with Parkinson’s. 

Pinto C, Pagnussat AS, Rozin Kleiner AF, et al. Automated Mechanical Peripheral Stimulation Improves Gait Parameters in Subjects with Parkinson Disease and Freezing of Gait: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2018;97(6):383-389.

For this study, the participants should have had the following criteria: a diagnosis of idiopathic PD, with no other significant neurological, orthopedic, or cognitive disorders; aged between 50 and 85; ability to walk 25 feet with or without assistive devices; presenting regular FOG episodes. 

Gait parameters were measured in subjects at baseline, after the first session, after the fourth session, and after the eighth session. In addition, the patients underwent AMPS or placebo treatment every 3-4 days for a total of eight. 

The AMPS group improved gradually and constantly in all the walking parameters, such as joint angles, speed, and step length. In contrast, the placebo group did not show any considerable improvements.

The current results demonstrate that AMPS improves gait issues in this Parkinson’s people. Non-invasive peripheral stimulation, such as that provided by AMPS, may play an important role in PD rehabilitation strategies. 

Kleiner AFR, Souza Pagnussat A, Pinto C, Redivo Marchese R, Salazar AP, Galli M. Automated Mechanical Peripheral Stimulation Effects on Gait Variability in Individuals With Parkinson Dise ase and Freezing of Gait: A Double-Blind, Randomized Controlled Trial. Arch Phys Med Rehabil. 2018;99(12):2420-2429.

The participants were diagnosed with idiopathic PD and no other significant neurological, orthopedic, or cognitive problems; between 50 and 85 years. They were able to walk 25 feet unassisted or with assistive devices and present regular FOG episodes.

The subjects underwent eight sessions of effective or placebo AMPS while off medications once every 3 to 4 days during the 4-week study. 

The patients were evaluated four times: before and after the first, after four, and after eight treatments.

At each session, patients in the AMPS group gradually improved step length, walking speed, and gait asymmetry. In contrast, the sham group showed no significant changes in the gait parameters. However, after eight stimulations, the AMPS group presented an increase in velocity compared to the sham group. Moreover, after eight sessions, the AMPS group had a greater step length than the sham group. 

The current results demonstrate that AMPS can improve gait variability in subjects with PD and FOG. Therefore, non-invasive peripheral stimulations, like the one delivered by Gondola® AMPS, may play an important role in PD rehabilitation strategies.

Zamunér AR, Shiffer D, Barbic F, et al. Mechanical somatosensory stimulation decreases blood pressure in patients with Parkinson’s disease. J Hypertens. 2019;37(8):1714-1721.

This study focused on assessing the Gondola AMPS therapy effects on Blood Pressure and Cardiovascular Autonomic Control, two aspects of this neurological disorder that usually are not investigated in the clinical protocols designed from a walking and gait rehabilitation perspective. 

The subjects had idiopathic Parkinson’s, characterized by moderate-to-severe motor impairment (H&Y stage 2-4). They underwent 5 AMPS sessions (one every three days). They were evaluated for several clinically relevant parameters at baseline (before the first AMPS) and at the end of the protocol (72 hours after the last AMPS). The assessments performed included: an ECG, a non-invasive beat-to-beat evaluation, cardiac output, total peripheral resistance, respiratory activity monitoring, and Systolic and Diastolic Blood Pressure (respectively, SBP and DBP) assessment. 

All the data were collected, put in digital format, and analyzed according to well-established analytical approaches (i.e., spectral and cross-spectral, symbolic, and baroreflex analysis). 

The study’s results revealed that Gondola AMPS represents a valid and non-invasive therapy able to control the supine hypertension issues commonly arising in Parkinson’s Disease. Furthermore, despite showing severe motor symptomatology, the enrolled patients displayed significant improvement in cardiovascular function after 5 AMPS therapeutic sessions delivered regularly through the Gondola Medical Device. 

In particular, AMPS Gondola therapy was proven to lower Blood Pressure, increase baroreflex sensitivity, and lower sympathetic modulation.

Pagnussat AS, Salazap AP, Pinto C, Kleiner AFR, et al. Plantar stimulation alters brain connectivity in idiopathic Parkinson’s Disease. Acta Neurol Scand . 2020 Sep;142(3):229-238.

This study aimed to investigate the long-term effects of Gondola AMPS Therapy on brain activity, brain functional connectivity, and walking speed in patients with Parkinson’s and recurrent Freezing of Gait (FOG). The PD and FOG patients underwent brain fMRI examinations before and after an 8-session treatment of either effective AMPS or placebo stimulation (SHAM treatment). At the same time, walking speed was measured for each patient to monitor clinically relevant gait changes. Pagnussat and colleagues exploited fMRI technology to investigate multiple hypotheses:

  1. They observed that neither AMPS nor SHAM treatments could induce significant changes in brain activity during an active-task assessment (while the patient was asked to perform an active dorsi-plantar flexion).
  2. Eight sessions of AMPS (but not of SHAM stimulations) administered 2 times a week for 4 weeks were instead capable of inducing a significant increase in functional brain connectivity observed at rest. In particular, a stronger functional connection was observed between the Basal Ganglia (a region known to be involved in the pathogenesis of PD) and sensory-related brain areas.
  3. Gait velocity significantly increased following the effective AMPS treatment.

Interestingly, the study’s authors observed a bigger improvement in clinical performance corresponding to a higher increase in brain connectivity between sensory, motor, and supplementary motor cortices. Overall, these data support the validity of Gondola AMPS therapy in ameliorating gait and facilitating the rehabilitation process in patients affected by Parkinson’s and Freezing of Gait.

Want to discuss Gondola AMPS therapy with your therapist? Download the documentation about the clinical trials