An observational study in Multiple Sclerosis, Parkinson Disease and Peripheral Neuropathy, sponsored by Istituto Auxologico Italiano. Recruiting at 2 sites in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Istituto Auxologico Italiano · Observational
Rare and very rare neurological diseases primarily or exclusively affect the nervous system with a prevalence of \< 5 out of 10'000 and 100'000 people, respectively. Besides these, there are undiagnosed neurological diseases: neurological conditions without a diagnosis after completing a full diagnostic examination.
Rare, very rare, and undiagnosed neurological diseases are complicated and progressive and often cause variegated motor signs, impairments, and syndromes.
Balance and gait are frequently affected in these conditions, already at the clinical examination. These balance and gait impairments limit activities and cause an increased risk of falling. Falls can eventually result in injuries, even severe.
There are only a few studies about these diseases, likely because of their rarity. Hence, the clinical presentation and the course of rare and very rare diseases are poorly known or even unknown. Essential information for these conditions' diagnosis, prognosis, treatment and rehabilitation is missing.
MaNeNeND is an observational study underway at the Fondazione IRCCS Istituto Neurologico "Carlo Besta" (Milano) aimed at detailing the clinical and biological features of very rare and undiagnosed neurological diseases.
Research questions:
The current project aims at diagnosing, quantifying and detailing the balance and gait impairment in rare, very rare and undiagnosed neurological diseases.
To this aim, questionnaires, clinical scales and instrumental tests will be administered to these patients to collect a wide range of balance and gait measures.
These measures will also integrate those collected with MaNeNeND to provide a more detailed description of patients with rare, very rare and diagnosed neurological diseases.
Participants will complete two questionnaires: the Dizziness Handicap Inventory - short form (DHI-sf, an ordinal score of self-perceived balance) and the Modified Fatigue Impact Scale (MFIS, an ordinal score of self-perceived fatigue).
Moreover, a clinician will administer the Mini Balance Evaluation Systems Test (Mini-BESTest, an ordinal score of balance), the 10 m walking test (for measuring the gait speed and other gait parameters) and the Timed Up and Go test (an instrumental measure of mobility and balance). Walking and the Timed Up and Go tests will be recorded with a trunk-worn inertial measurement unit.
Finally, participants will be asked to complete an instrumental upright stance and gait assessment, the first consisting of standing on posturographic plates and the second of walking on a treadmill equipped with force sensors. When walking on the treadmill, an optoelectronic system will also record the position in time of limbs and trunk.
The quantification of the severity of the balance and gait impairment of the patients suffering a rare, very rare or undiagnosed neurological disease will highlight these persons' therapeutic and rehabilitative needs.
Comparing the balance and gait impairment of rare, very rare and undiagnosed diseases with those of multiple sclerosis, Parkinson's disease and peripheral neuropathy will highlight if the formers' balance and gait impairment has unique characteristics that could help ease the diagnosis of these uncommon conditions.
The longitudinal measurements on rare, very rare and undiagnosed diseases will be paramount to identifying prognostic factors.
In addition, the data collected in the current study will be crucial for future studies, for example, for estimating the sample size in clinical trials.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a balance and gait impairment secondary to multiple sclerosis, Parkinson's disease, peripheral neuropathy of the lower limbs, a rare, ultrarare or undiagnosed neurological disease.
A group of age-matched controls will also be recruited.
Exclusion criteria
Other: Questionnaires, clinical scales and instrumental tests
Other: Questionnaires, clinical scales and instrumental tests
Other: Questionnaires, clinical scales and instrumental tests
Other: Questionnaires, clinical scales and instrumental tests
Other: Questionnaires, clinical scales and instrumental tests
Questionnaires, clinical scales and instrumental tests to collect a wide range of balance and gait measures.
Balance (Mini-BESTest)
Mini Balance Evaluation Systems Test (Mini-BESTest, an ordinal score of balance)
Time frame: At enrollment
Balance (Timed Up and Go test)
Timed Up and Go test instrumented with inertial sensors
Time frame: At enrollment
Gait speed
10 m walking test
Time frame: At enrollment
Gait analysis - kinematic - stride length
Stride length, right step length and left step length
Time frame: At enrollment
Gait analysis - kinematic - duration
Stride duration, right and left step duration
Time frame: At enrollment
Gait analysis - kinematic - width of the base of support
Width of the base of support
Time frame: At enrollment
Gait analysis - kinematic - dorsal ankle angle
Dorsal ankle angle
Time frame: At enrollment
Gait analysis - dynamic - reaction force
Anterior-posterior, mediolateral and vertical reaction force
Time frame: At enrollment
Gait analysis - dynamic - ankle power
Right and left ankle power
Time frame: At enrollment
Gait analysis - dynamic - energy
Potential and kinetic energy of the body centre of mass
Time frame: At enrollment
Posturography - static - centre of pressure position
Centre of pressure position while standing
Time frame: At enrollment
Posturography - static - centre of mass position
Centre of mass position while standing
Time frame: At enrollment
Posturography - dynamic - centre of pressure position
Centre of pressure position after base of support perturbations
Time frame: At enrollment
Posturography - dynamic - centre of mass position
Centre of mass position after base of support perturbations
Time frame: At enrollment
Plan to share: No — The database will be made available upon request on Zenodo.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Istituto Auxologico Italiano