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Multiple SclerosisGALVANISENCT06343558

Gait and Balance Impairment in Rare and Very Rare Neurological Diseases

An observational study of Multiple Sclerosis and Parkinson Disease, run by Istituto Auxologico Italiano at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Questionnaires, clinical scales and instrumental tests
How many people
200 participants
Where
2 sitesItaly
Study dates
30 May 2023to 1 May 2027
How long will I take part?
1 Year
Phase
Observational
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

Study population: 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.

Who may be able to join

  • Multiple sclerosis, Parkinson's disease, peripheral neuropathy of the lower limbs or rare or ultrarare neurological disease (e.g. la Cerebellar Ataxia with Neuropathy and Vestibular Areflexia Syndrome - CANVAS, ORPHAcode: 504476; Wilson's disease, ORPHAcode: 905)
  • undiagnosed neurological disease, i.e. a neurological disease that remains unknown after a full diagnostic assessment;
  • age > 18 years;
  • ability to stand upright with no assistance and no assistive device for > 30 seconds;
  • ability to walk without assistance and with no assistive device for > 50 m;
  • ability to give their informed consent.

Who cannot join

  • pregnancy or breastfeeding
  • any other medical conditions affecting by itself balance and gait (e.g. lower limb amputation, hemiparesis due to a stroke)
  • major orthopaedic surgery (e.g. hip or knee replacement).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy2 sites, 1 recruiting
  • IRCCS Istituto Auxologico Italiano

    Milan, Milan

    Antonio Caronni, MD, PhD, 02 619111, a.caronni@auxologico.it

    Recruiting
  • IRCCS Istituto Neurologico Carlo Besta

    Milan

    Active, not recruiting

Other trials in Italy

About this study

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.

Read more

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:

  1. Do patients with rare (Ra), very rare (V) and undiagnosed (U) neurological diseases suffer a balance and gait impairment?
  2. Is there a correlation between the clinical and instrumental severity of the balance and gait impairment in RaVU neurological diseases?
  3. Are instrumental measures more sensitive in detecting balance and gait impairments in patients affected by a RaVU neurological disease than the clinical measures?
  4. Do the balance and gait impairments in RaVU neurological diseases worsen in time?

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.

Being tested
Questionnaires, clinical scales and instrumental tests
Keywords
Rare neurological diseases, Very rare neurological diseases, Undiagnosed neurological diseases, Upright stance, Balance, Risk of falling, Gait analysis, Posturography
Medical subject headings
Multiple Sclerosis, Parkinson Disease, Peripheral Nervous System Diseases, Rare Diseases

What participants receive

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

  • Questionnaires, clinical scales and instrumental testsOther

    Questionnaires, clinical scales and instrumental tests to collect a wide range of balance and gait measures.

Study groups in NCT06343558
Study groupRoleWhat they receive
Healthy controlsNot described
Receives: Other: Questionnaires, clinical scales and instrumental tests
Parkinson's disease patientsNot described
Receives: Other: Questionnaires, clinical scales and instrumental tests
Multiple sclerosis patientsNot described
Receives: Other: Questionnaires, clinical scales and instrumental tests
Peripheral neuropathies of the lower limbsNot described
Receives: Other: Questionnaires, clinical scales and instrumental tests
Rare and ultrarare neurological diseasesNot described
Receives: Other: Questionnaires, clinical scales and instrumental tests

What is being measured

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

  1. Balance (Mini-BESTest)

    Mini Balance Evaluation Systems Test (Mini-BESTest, an ordinal score of balance)

    Measured: At enrollment

  2. Balance (Timed Up and Go test)

    Timed Up and Go test instrumented with inertial sensors

    Measured: At enrollment

  3. Gait speed

    10 m walking test

    Measured: At enrollment

  4. Gait analysis - kinematic - stride length

    Stride length, right step length and left step length

    Measured: At enrollment

  5. Gait analysis - kinematic - duration

    Stride duration, right and left step duration

    Measured: At enrollment

  6. Gait analysis - kinematic - width of the base of support

    Width of the base of support

    Measured: At enrollment

  7. Gait analysis - kinematic - dorsal ankle angle

    Dorsal ankle angle

    Measured: At enrollment

  8. Gait analysis - dynamic - reaction force

    Anterior-posterior, mediolateral and vertical reaction force

    Measured: At enrollment

  9. Gait analysis - dynamic - ankle power

    Right and left ankle power

    Measured: At enrollment

  10. Gait analysis - dynamic - energy

    Potential and kinetic energy of the body centre of mass

    Measured: At enrollment

  11. Posturography - static - centre of pressure position

    Centre of pressure position while standing

    Measured: At enrollment

  12. Posturography - static - centre of mass position

    Centre of mass position while standing

    Measured: At enrollment

  13. Posturography - dynamic - centre of pressure position

    Centre of pressure position after base of support perturbations

    Measured: At enrollment

  14. Posturography - dynamic - centre of mass position

    Centre of mass position after base of support perturbations

    Measured: At enrollment

Timeline

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

  1. First posted2 Apr 2024
  2. Study start30 May 2023
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06343558
Sponsor's protocol ID
24C302
Acronym
GALVANISE
Status last verified
Jul 2025
First submitted
8 Mar 2024
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The database will be made available upon request on Zenodo.

Publications

  • Reinhard C, Bachoud-Levi AC, Baumer T, Bertini E, Brunelle A, Buizer AI, Federico A, Gasser T, Groeschel S, Hermanns S, Klockgether T, Krageloh-Mann I, Landwehrmeyer GB, Leber I, Macaya A, Mariotti C, Meissner WG, Molnar MJ, Nonnekes J, Ortigoza Escobar JD, Perez Duenas B, Renna Linton L, Schols L, Schuele R, Tijssen MAJ, Vandenberghe R, Volkmer A, Wolf NI, Graessner H. The European Reference Network for Rare Neurological Diseases. Front Neurol. 2021 Jan 14;11:616569. doi: 10.3389/fneur.2020.616569. eCollection 2020.

    PubMed 33519696
  • The Lancet Neurology. Rare neurological diseases: a united approach is needed. Lancet Neurol. 2011 Feb;10(2):109. doi: 10.1016/S1474-4422(11)70001-1. No abstract available.

    PubMed 21256450
  • Ganz DA, Bao Y, Shekelle PG, Rubenstein LZ. Will my patient fall? JAMA. 2007 Jan 3;297(1):77-86. doi: 10.1001/jama.297.1.77.

    PubMed 17200478
  • Vieira ER, Palmer RC, Chaves PH. Prevention of falls in older people living in the community. BMJ. 2016 Apr 28;353:i1419. doi: 10.1136/bmj.i1419. No abstract available.

    PubMed 27125497
  • Caronni A, Sterpi I, Antoniotti P, Aristidou E, Nicolaci F, Picardi M, Pintavalle G, Redaelli V, Achille G, Sciume L, Corbo M. Criterion validity of the instrumented Timed Up and Go test: A partial least square regression study. Gait Posture. 2018 Mar;61:287-293. doi: 10.1016/j.gaitpost.2018.01.015. Epub 2018 Jan 31.

    PubMed 29413799
  • Picardi M, Redaelli V, Antoniotti P, Pintavalle G, Aristidou E, Sterpi I, Meloni M, Corbo M, Caronni A. Turning and sit-to-walk measures from the instrumented Timed Up and Go test return valid and responsive measures of dynamic balance in Parkinson's disease. Clin Biomech (Bristol). 2020 Dec;80:105177. doi: 10.1016/j.clinbiomech.2020.105177. Epub 2020 Sep 18.

    PubMed 32979787
  • Caronni A, Gervasoni E, Ferrarin M, Anastasi D, Brichetto G, Confalonieri P, Di Giovanni R, Prosperini L, Tacchino A, Solaro C, Rovaris M, Cattaneo D, Carpinella I. Local Dynamic Stability of Gait in People With Early Multiple Sclerosis and No-to-Mild Neurological Impairment. IEEE Trans Neural Syst Rehabil Eng. 2020 Jun;28(6):1389-1396. doi: 10.1109/TNSRE.2020.2991636. Epub 2020 Apr 30.

    PubMed 32356754
  • Scarano S, Sansone VA, Ferrari Aggradi CR, Carraro E, Tesio L, Amadei M, Rota V, Zanolini A, Caronni A. Balance impairment in myotonic dystrophy type 1: Dynamic posturography suggests the coexistence of a proprioceptive and vestibular deficit. Front Hum Neurosci. 2022 Jul 28;16:925299. doi: 10.3389/fnhum.2022.925299. eCollection 2022.

    PubMed 35967003
  • Scarano S, Rota V, Tesio L, Perucca L, Robecchi Majnardi A, Caronni A. Balance Impairment in Fahr's Disease: Mixed Signs of Parkinsonism and Cerebellar Disorder. A Case Study. Front Hum Neurosci. 2022 Mar 9;16:832170. doi: 10.3389/fnhum.2022.832170. eCollection 2022.

    PubMed 35355583

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Parkinson Disease, run by Istituto Auxologico Italiano at 2 sites in Italy.

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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance (Mini-BESTest) (time frame: At enrollment). The study lists 14 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 NCT06343558, which also lists 9 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 3 Aug 2025.

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