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.
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
- Conditions the study is for
- Multiple Sclerosis, Parkinson Disease, Peripheral Neuropathy
- 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
- Recruiting
IRCCS Istituto Auxologico Italiano
Milan, Milan
Antonio Caronni, MD, PhD, 02 619111, a.caronni@auxologico.it
- Active, not recruiting
IRCCS Istituto Neurologico Carlo Besta
Milan
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:
- Do patients with rare (Ra), very rare (V) and undiagnosed (U) neurological diseases suffer a balance and gait impairment?
- Is there a correlation between the clinical and instrumental severity of the balance and gait impairment in RaVU neurological diseases?
- Are instrumental measures more sensitive in detecting balance and gait impairments in patients affected by a RaVU neurological disease than the clinical measures?
- 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.
- Conditions
- Multiple Sclerosis, Parkinson Disease, Peripheral Neuropathy, Rare Diseases, Healthy, Healthy Aging
- 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 group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described Receives: Other: Questionnaires, clinical scales and instrumental tests | |
| Parkinson's disease patients | Not described Receives: Other: Questionnaires, clinical scales and instrumental tests | |
| Multiple sclerosis patients | Not described Receives: Other: Questionnaires, clinical scales and instrumental tests | |
| Peripheral neuropathies of the lower limbs | Not described Receives: Other: Questionnaires, clinical scales and instrumental tests | |
| Rare and ultrarare neurological diseases | Not 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.
Balance (Mini-BESTest)
Mini Balance Evaluation Systems Test (Mini-BESTest, an ordinal score of balance)
Measured: At enrollment
Balance (Timed Up and Go test)
Timed Up and Go test instrumented with inertial sensors
Measured: At enrollment
Gait speed
10 m walking test
Measured: At enrollment
Gait analysis - kinematic - stride length
Stride length, right step length and left step length
Measured: At enrollment
Gait analysis - kinematic - duration
Stride duration, right and left step duration
Measured: At enrollment
Gait analysis - kinematic - width of the base of support
Width of the base of support
Measured: At enrollment
Gait analysis - kinematic - dorsal ankle angle
Dorsal ankle angle
Measured: At enrollment
Gait analysis - dynamic - reaction force
Anterior-posterior, mediolateral and vertical reaction force
Measured: At enrollment
Gait analysis - dynamic - ankle power
Right and left ankle power
Measured: At enrollment
Gait analysis - dynamic - energy
Potential and kinetic energy of the body centre of mass
Measured: At enrollment
Posturography - static - centre of pressure position
Centre of pressure position while standing
Measured: At enrollment
Posturography - static - centre of mass position
Centre of mass position while standing
Measured: At enrollment
Posturography - dynamic - centre of pressure position
Centre of pressure position after base of support perturbations
Measured: At enrollment
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.
- First posted2 Apr 2024
- Study start30 May 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 33519696The 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 21256450Ganz 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 17200478Vieira 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 27125497Caronni 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 29413799Picardi 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 32979787Caronni 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 32356754Scarano 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 35967003Scarano 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait and Balance Impairment in Rare and Very Rare Neurological Diseases
- ClinicalTrials.gov ID
- NCT06343558
- Acronym / sponsor ID
- GALVANISE / 24C302
- Conditions
- Multiple Sclerosis, Parkinson Disease, Peripheral Neuropathy, Rare Diseases, Healthy, Healthy Aging
- Keywords
- Rare neurological diseases, Very rare neurological diseases, Undiagnosed neurological diseases, Upright stance, Balance, Risk of falling, Gait analysis, Posturography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Study start
- 30 May 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do patients with rare (Ra), very rare (V) and undiagnosed (U) neurological diseases suffer a balance and gait impairment?
- Is there a correlation between the clinical and instrumental severity of the balance and gait impairment in RaVU neurological diseases?
- Are instrumental measures more sensitive in detecting balance and gait impairments in patients affected by a RaVU neurological disease than the clinical measures?
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Other: Questionnaires, clinical scales and instrumental tests |
| Parkinson's disease patients | – | Other: Questionnaires, clinical scales and instrumental tests |
| Multiple sclerosis patients | – | Other: Questionnaires, clinical scales and instrumental tests |
| Peripheral neuropathies of the lower limbs | – | Other: Questionnaires, clinical scales and instrumental tests |
| Rare and ultrarare neurological diseases | – | Other: Questionnaires, clinical scales and instrumental tests |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires, clinical scales and instrumental testsQuestionnaires, clinical scales and instrumental tests to collect a wide range of balance and gait measures. | Other | Healthy controls, Multiple sclerosis patients, Parkinson's disease patients, Peripheral neuropathies of the lower limbs, Rare and ultrarare neurological diseases |
Primary outcome
Balance (Mini-BESTest)
Time frame: At enrollment
Mini Balance Evaluation Systems Test (Mini-BESTest, an ordinal score of balance)
Balance (Timed Up and Go test)
Time frame: At enrollment
Timed Up and Go test instrumented with inertial sensors
Gait speed
Time frame: At enrollment
10 m walking test
Gait analysis - kinematic - stride length
Time frame: At enrollment
Stride length, right step length and left step length
Gait analysis - kinematic - duration
Time frame: At enrollment
Stride duration, right and left step duration
Gait analysis - kinematic - width of the base of support
Time frame: At enrollment
Width of the base of support
Gait analysis - kinematic - dorsal ankle angle
Time frame: At enrollment
Dorsal ankle angle
Gait analysis - dynamic - reaction force
Time frame: At enrollment
Anterior-posterior, mediolateral and vertical reaction force
Gait analysis - dynamic - ankle power
Time frame: At enrollment
Right and left ankle power
Gait analysis - dynamic - energy
Time frame: At enrollment
Potential and kinetic energy of the body centre of mass
Posturography - static - centre of pressure position
Time frame: At enrollment
Centre of pressure position while standing
Posturography - static - centre of mass position
Time frame: At enrollment
Centre of mass position while standing
Posturography - dynamic - centre of pressure position
Time frame: At enrollment
Centre of pressure position after base of support perturbations
Posturography - dynamic - centre of mass position
Time frame: At enrollment
Centre of mass position after base of support perturbations
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 33519696Reinhard 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.
- Background: PubMed 21256450The 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.
- Background: PubMed 17200478Ganz 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.
- Background: PubMed 27125497Vieira 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.
- Background: PubMed 29413799Caronni 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.
- Background: PubMed 32979787Picardi 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.
- Background: PubMed 32356754Caronni 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.
- Background: PubMed 35967003Scarano 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.
- Background: PubMed 35355583Scarano 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.
- Individual participant dataSharing planned: No. The database will be made available upon request on Zenodo.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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.