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RehabilitationNEUROSTABNCT07029620

Peripheral Neuropathy Rehabilitation With Stabilometric Platforms (NEUROSTAB)

A study testing Balance and postural rehabilitation using sensor-based stabilometric platform (GEAMASTER) under static and dynamic conditions, Conventional balance and gait rehabilitation program and Stabilometric assessment in healthy volunteers in people with Rehabilitation and Balance, run by Ospedale Policlinico San Martino.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Rehabilitation, Balance
What is being tested?
Balance and postural rehabilitation using sensor-based stabilometric platform (GEAMASTER) under static and dynamic conditions, Conventional balance and gait rehabilitation program and Stabilometric assessment in healthy volunteers
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
25 Jun 2025to 20 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Angelo Schenone, MD contact

0039-3537040

angelo.schenone@unige.it

About this study

Official title: Evaluation and Rehabilitation of Patients With Peripheral Neuropathy Using Static and Dynamic Stabilometric Platforms: NEUROSTAB

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.

Read more

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.

Being tested
Balance and postural rehabilitation using sensor-based stabilometric platform (GEAMASTER) under static and dynamic conditions, Conventional balance and gait rehabilitation program, Stabilometric assessment in healthy volunteers
Keywords
Peripheral Neuropathy, Postural Control, Stabilometric Platform, Dynamic Balance, Static Balance, Rehabilitation, Neurorehabilitation, Balance Training
Medical subject headings
Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 programOther

    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 volunteersOther

    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.

Study groups in NCT07029620
Study groupRoleWhat they receive
Instrumented Balance (GeaMaster) Training GroupExperimentalParticipants 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.
Receives: Device: Balance and postural rehabilitation using sensor-based stabilometric platform (GEAMASTER) under static and dynamic conditions
Active Comparator: Traditional Rehabilitation Training GroupActive comparatorParticipants 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.
Receives: Other: Conventional balance and gait rehabilitation program
Reference Arm: Healthy Subjects GroupOtherParticipants 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.
Receives: Other: Stabilometric assessment in healthy volunteers

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

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

Secondary outcomes (3)
  1. Correlation between additional stabilometric parameters (static balance, dynamic balance, fall risk, and mobility) and clinical outcomes

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2025
  2. Study start25 Jun 2025 (estimated)
  3. Primary completion20 May 2026 (estimated)
  4. Study completion20 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study type: interventional. Allocation: randomized Intervention model: parallel assignment (1:1) This study involves two treatment groups of patients with peripheral neuropathies and one additional non-treatment group of healthy subjects. The healthy control group is not part of the therapeutic comparison; rather, it is included exclusively for the purpose of evaluating the reproducibility of the stabilometric measurements recorded with the GEAMASTER platform. The main comparison of treatment efficacy is conducted only between the two patient groups.
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07029620
Sponsor's protocol ID
NEUROSTAB - PNC0000007
Other IDs
#PNC0000007
Acronym
NEUROSTAB
Status last verified
Apr 2025
First submitted
11 Jun 2025
Last updated
19 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baratto L, Morasso PG, Re C, Spada G. A new look at posturographic analysis in the clinical context: sway-density versus other parameterization techniques. Motor Control. 2002 Jul;6(3):246-70. doi: 10.1123/mcj.6.3.246.

    PubMed 12122219
  • Scoppa F, Capra R, Gallamini M, Shiffer R. Clinical stabilometry standardization: basic definitions--acquisition interval--sampling frequency. Gait Posture. 2013 Feb;37(2):290-2. doi: 10.1016/j.gaitpost.2012.07.009. Epub 2012 Aug 11.

    PubMed 22889928
  • Wright DJ, Holmes PS, Smith D. Using the movement-related cortical potential to study motor skill learning. J Mot Behav. 2011;43(3):193-201. doi: 10.1080/00222895.2011.557751.

    PubMed 21462065
  • Shibasaki H. Cortical activities associated with voluntary movements and involuntary movements. Clin Neurophysiol. 2012 Feb;123(2):229-43. doi: 10.1016/j.clinph.2011.07.042. Epub 2011 Sep 8.

    PubMed 21906995
  • Prada V, Mori L, Accogli S, Rivarola M, Schizzi S, Hamedani M, Schenone A. Testing overwork weakness in Charcot-Marie-tooth disease: Is it true or false? J Peripher Nerv Syst. 2018 Jun;23(2):124-128. doi: 10.1111/jns.12270. Epub 2018 May 7.

    PubMed 29693294
  • Gess B, Baets J, De Jonghe P, Reilly MM, Pareyson D, Young P. Ascorbic acid for the treatment of Charcot-Marie-Tooth disease. Cochrane Database Syst Rev. 2015 Dec 11;2015(12):CD011952. doi: 10.1002/14651858.CD011952.

    PubMed 26662471
  • Rose KJ, Hiller CE, Mandarakas M, Raymond J, Refshauge K, Burns J. Correlates of functional ankle instability in children and adolescents with Charcot-Marie-Tooth disease. J Foot Ankle Res. 2015 Nov 5;8:61. doi: 10.1186/s13047-015-0118-1. eCollection 2015.

    PubMed 26543504
  • Pareyson D, Scaioli V, Laura M. Clinical and electrophysiological aspects of Charcot-Marie-Tooth disease. Neuromolecular Med. 2006;8(1-2):3-22. doi: 10.1385/nmm:8:1-2:3.

    PubMed 16775364
  • Eggermann K, Gess B, Hausler M, Weis J, Hahn A, Kurth I. Hereditary Neuropathies. Dtsch Arztebl Int. 2018 Feb 9;115(6):91-97. doi: 10.3238/arztebl.2018.0091.

    PubMed 29478438
  • Mathis S, Magy L, Le Masson G, Richard L, Soulages A, Sole G, Duval F, Ghorab K, Vallat JM, Duchesne M. Value of nerve biopsy in the management of peripheral neuropathies. Expert Rev Neurother. 2018 Jul;18(7):589-602. doi: 10.1080/14737175.2018.1489240. Epub 2018 Jun 25.

    PubMed 29923431

Questions about this trial

What is this clinical trial studying?

A study testing Balance and postural rehabilitation using sensor-based stabilometric platform (GEAMASTER) under static and dynamic conditions, Conventional balance and gait rehabilitation program and Stabilometric assessment in healthy volunteers in people with Rehabilitation and Balance, run by Ospedale Policlinico San Martino.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Angelo Schenone, MD (0039-3537040, angelo.schenone@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07029620, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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