An interventional study of Balance and postural rehabilitation using sensor-based stabilometric platform (GEAMASTER) under static and dynamic conditions and Conventional balance and gait rehabilitation program in Rehabilitation and Balance, sponsored by Ospedale Policlinico San Martino. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Ospedale Policlinico San Martino · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
Exclusion Criteria:
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.
Device: Balance and postural rehabilitation using sensor-based stabilometric platform (GEAMASTER) under static and dynamic conditions
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.
Other: Conventional balance and gait rehabilitation program
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.
Other: Stabilometric assessment in healthy volunteers
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.
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.
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.
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
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
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
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
No study locations are listed for this record.
Plan to share: No
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Peripheral Nervous System Diseases→
Ospedale Policlinico San Martino