Assessing gait and balance in rare neurological diseases

Gait and Balance Impairment in Rare and Very Rare Neurological Diseases

This study looks at how walking and balance are affected in people with rare neurological diseases to better understand their challenges and risks of falling.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Istituto Auxologico Italiano (Academic / other)
• Locations: 2 sites (Milan, Milan and 1 other locations)
• Trial ID: NCT06343558 on ClinicalTrials.gov

What this trial studies

This observational study focuses on individuals with rare and very rare neurological diseases, including conditions like multiple sclerosis and Parkinson's disease. It aims to evaluate gait and balance impairments that are common in these conditions, which can lead to increased fall risk and injuries. Participants will undergo assessments using questionnaires, clinical scales, and instrumental tests to gather essential data on their motor functions. The study seeks to improve understanding of these diseases, which are often poorly characterized due to their rarity.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with multiple sclerosis, Parkinson's disease, peripheral neuropathy, or other rare neurological conditions.

Not a fit: Patients with conditions affecting balance and gait due to other medical issues, such as lower limb amputation or recent major orthopedic surgery, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance diagnosis and treatment strategies for patients with rare neurological diseases.

How similar studies have performed: While there are few studies on rare neurological diseases, existing research has shown that understanding gait and balance can lead to better management of these conditions.

Eligibility criteria

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Where this trial is running

Milan, Milan and 1 other locations

• IRCCS Istituto Auxologico Italiano — Milan, Milan, Italy (Recruiting)
• IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Active_not_recruiting)

Conditions Multiple Sclerosis; Parkinson Disease; Peripheral Neuropathy; Rare Diseases; Healthy; Healthy Aging; Rare neurological diseases; Very rare neurological diseases