Evaluation and Rehabilitation of Patients With Peripheral Neuropathy Using Static and Dynamic Stabilometric Platforms: NEUROSTAB
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 100
- Primary Endpoint
- Correlation between sway area and sway path values and scores on the Berg Balance Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
The randomization process is conducted by a staff member who is not involved in either the treatment delivery or the outcome assessments.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Instrumented Balance (GeaMaster) Training Group
Participants in this arm are patients diagnosed with peripheral neuropathy who will undergo a structured rehabilitation program supported by the GEAMASTER stabilometric platform. The intervention involves balance training sessions during which the GEAMASTER device provides real-time postural feedback by measuring center-of-pressure shifts under both static and dynamic conditions.
Intervention: Balance and postural rehabilitation using sensor-based stabilometric platform (GEAMASTER) under static and dynamic conditions (Device)
Active Comparator: Traditional Rehabilitation Training Group
Participants in this arm are patients diagnosed with peripheral neuropathy who will undergo a structured rehabilitation program using traditional physiotherapy methods. The intervention includes balance and gait training exercises without technological support, such as weight shifting, static and dynamic balance tasks, and obstacle navigation performed on conventional surfaces.
Intervention: Conventional balance and gait rehabilitation program (Other)
Reference Arm: Healthy Subjects Group
Participants in this arm are healthy individuals with no history of neurological or balance disorders who will undergo stabilometric assessments using the GEAMASTER platform. The purpose of this arm is to establish normative data and evaluate the test-retest reliability of the device under both static and dynamic conditions.
Intervention: Stabilometric assessment in healthy volunteers (Other)
Outcomes
Primary Outcomes
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
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
- 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)