Peripheral Neuropathy Rehabilitation With Stabilometric Platforms (NEUROSTAB)

Summary

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.

Conditions

• Rehabilitation
• Balance

Interventions

DEVICE

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

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.

OTHER

Conventional balance and gait rehabilitation program

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.

OTHER

Stabilometric assessment in healthy volunteers

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.

Sponsors & Collaborators

• Ospedale Policlinico San Martino

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-25

Primary Completion

2026-05-20

Completion

2026-06-20