Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343558
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-08
Brief Title:
Gait and Balance Impairment in Rare and Very Rare Neurological Diseases
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Gait and Balance Impairment in Rare and Very Rare Neurological Diseases
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GALVANISE
Brief Summary:
Rare and very rare neurological diseases primarily or exclusively affect the nervous system with a prevalence of 5 out of 10000 and 100000 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
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 Parkinsons 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
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
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 Parkinsons 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None