Peripheral Neuropathy Rehabilitation With Stabilometric Platforms (NEUROSTAB)

Not Applicable

Not yet recruiting

• Conditions: Rehabilitation; Balance

• Registration Number: NCT07029620
• Lead Sponsor: Ospedale Policlinico San Martino

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Study Start: 2025-06-25
• Primary Completion: 2026-05-20
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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
• Pharmacological treatment stability during the last 6 months

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Correlation between sway area and sway path values and scores on the Berg Balance Scale	From baseline (T0) to one-month post-treatment follow-up (T2), approximately 8 weeks total
Correlation between sway area and sway path values and performance on the 10-Meter Walk Test	From baseline (T0) to one-month post-treatment follow-up (T2), approximately 8 weeks total

Secondary Outcome Measures

Name	Time	Method
Correlation between additional stabilometric parameters (static balance, dynamic balance, fall risk, and mobility) and clinical outcomes	From baseline (T0) to one-month post-treatment follow-up (T2), approximately 8 weeks total
Temporal and frequency domain analysis of movement-related cortical potentials in upper and lower limbs	From baseline (T0) to one-month post-treatment follow-up (T2), approximately 8 weeks total
Comparison of movement-related cortical activity in upper versus lower limbs to evaluate motor learning effects	From baseline (T0) to one-month post-treatment follow-up (T2), approximately 8 weeks total