Peripheral Neuropathy Rehabilitation With Stabilometric Platforms (NEUROSTAB)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOspedale Policlinico San Martino

About this trial

The goal of this clinical trial is to learn if the GeaMaster stabilometric platform can support rehabilitation and improve balance and walking ability in adults diagnosed with peripheral neuropathy. It will also evaluate whether the platform can provide objective and reliable data that match the results of standard clinical tests. The study will explore if brain and muscle activity, recorded during movement, can indicate how much motor learning and recovery has occurred.

Peripheral neuropathies are disorders of the peripheral nerves and can have many causes, including diabetes, autoimmune diseases, toxins, or inherited conditions such as Charcot-Marie-Tooth disease. Symptoms may include reduced sensation, muscle weakness, poor reflexes, balance problems, and frequent falls. Since there are no approved drugs for many of these conditions, physical therapy is the main treatment option.

The main questions this study aims to answer are:

* Does using GeaMaster improve balance and walking better than traditional rehabilitation alone? * Are GeaMaster's stabilometric data consistent with standard balance and gait test scores? * Can movement-related evoked potentials be used as biomarkers to track and predict motor recovery? To answer these questions, researchers will compare two groups of patients. One group will receive traditional physiotherapy. The other group will receive the same therapy with the support of the GeaMaster platform. Both groups will follow the treatment for 4 weeks. A group of healthy volunteers will also be included for comparison.

Participants will:

* Be adults aged 18 to 80. Patients must have a diagnosis of peripheral neuropathy and a stable condition. * Be randomly assigned to a control group (traditional rehab) or experimental group (rehab with GeaMaster). * Visit the clinic for balance and walking tests at three time points: before treatment (T0), after 4 weeks of treatment (T1), and 1 month later (T2). * Complete clinical tests such as the Berg Balance Scale, 6-Minute Walk Test, 10-Meter Walk Test, Tinetti Scale, and Modified Barthel Index. * Be assessed using the GeaMaster platform for postural stability under both static and dynamic conditions. * Undergo neurophysiological tests using EEG and EMG to record brain and muscle activity during tasks like walking, writing, or drawing.

Healthy volunteers will visit the clinic twice (5 days apart) to check how stable the GeaMaster measurements are over time.

GeaMaster is a robotic platform that uses compressed air to gently move the support surface and challenge a patient's balance. It offers different levels of difficulty and provides real-time visual feedback. Its design avoids mechanical inertia, making movements feel more natural and safe for patients of all ages.

The main outcome researchers will look for is a significant link between GeaMaster balance data and results of the Berg Balance Scale and the 10-Meter Walk Test. Other outcomes include performance on additional scales, the presence of balance improvements, risk of falling, and changes in movement-related brain signals.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy subjects aged between 18 and 80 years

Patients aged between 18 and 80 years with a diagnosis of peripheral neuropathy, according to international criteria

Patients must be at an equivalent stage of disease

Patients must be undergoing comparable and analogous treatments

Disqualifiers

Severe comorbidity

Presence of other neurological disorders or balance alterations due to other diseases (e.g., vestibular or cerebellar conditions)

Pain with VAS >3 in any body region

Orthopedic surgery within the past 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Balance and postural rehabilitation using sensor-based stabilometric platform (GEAMASTER) under static and dynamic conditions

    Device

    This intervention consists of a structured postural rehabilitation program supported by the GEAMASTER stabilometric platform. The device provides real-time feedback on center-of-pressure shifts and enables both static and dynamic balance training through interactive visual tasks. Exercises include multi-directional weight shifting, stability control, and task-specific balance strategies. The platform integrates sensor-based tracking and allows fine-grained analysis of postural parameters, distinguishing it from conventional physiotherapy by its precision, adaptability, and real-time feedback mechanisms.

  • Conventional balance and gait rehabilitation program

    Other intervention

    This intervention consists of a standardized physiotherapy program aimed at improving postural control and gait in patients with peripheral neuropathy. The rehabilitation protocol includes stretching, weight-shifting exercises, balance training on foam or unstable surfaces, and obstacle navigation. Unlike the experimental intervention, this program does not use any technological or sensor-based feedback systems. The content, frequency, and duration of the sessions are matched to those of the experimental arm to allow for comparative analysis of clinical outcomes.

  • Stabilometric assessment in healthy volunteers

    Other intervention

    This intervention involves a non-interventional assessment of healthy adult volunteers using the GEAMASTER stabilometric platform. The objective is to generate normative data for stabilometric parameters and to assess test-retest reliability of the device under static and dynamic conditions. Participants do not undergo any rehabilitation program or therapeutic intervention. The data collected will serve as a reference for interpreting pathological findings in patients with peripheral neuropathy.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Instrumented Balance (GeaMaster) Training GroupExperimental treatment 1 intervention
Group B: Active Comparator: Traditional Rehabilitation Training GroupActive comparator 1 intervention
Group C: Reference Arm: Healthy Subjects GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Correlation between sway area and sway path values and scores on the Berg Balance Scale

Time frame
From baseline (T0) to one-month post-treatment follow-up (T2), approximately 8 weeks total
2

Correlation between sway area and sway path values and performance on the 10-Meter Walk Test

Time frame
From baseline (T0) to one-month post-treatment follow-up (T2), approximately 8 weeks total

Secondary outcomes

1

Correlation between additional stabilometric parameters (static balance, dynamic balance, fall risk, and mobility) and clinical outcomes

Time frame
From baseline (T0) to one-month post-treatment follow-up (T2), approximately 8 weeks total
2

Temporal and frequency domain analysis of movement-related cortical potentials in upper and lower limbs

Time frame
From baseline (T0) to one-month post-treatment follow-up (T2), approximately 8 weeks total
3

Comparison of movement-related cortical activity in upper versus lower limbs to evaluate motor learning effects

Time frame
From baseline (T0) to one-month post-treatment follow-up (T2), approximately 8 weeks total

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: