NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Universita di Verona
Conditions: Progressive Multiple Sclerosis
Interventions: Digital Telerehabilitation (Euleria Home), Conventional therapy
Countries: Italy
Multiple sclerosis (MS) is a highly disabling chronic, inflammatory, demyelinating disease of the Central Nervous System (CNS). Significant progress has been made during the past three decades in managing the relapsing-remitting phase of Multiple Sclerosis (RRMS). However, once patients have entered the progressive stage of MS (secondary progressive, SPMS), therapeutic options are limited to symptomatic treatments and rehabilitation. In addition, 10-20% of patients experience unremitting disease progression (primary progressive MS, or PPMS). The limited research focusing on Progressive MS (PMS) and the lack of ecological validity highlight the need for a bolder approach that combines more than one intervention intending to produce synergistic effects. The primary aim is to test the effectiveness of combining a home-based Digital Telerehabilitation program with in-hospital rehabilitation on mobility against in-hospital rehabilitation alone.
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Age 18-75; * Diagnosis of MS (primary or secondary progressive); * Mild to moderate balance impairments with increased fall risk, defined as TUG \> 8.4s; * A disability rate, as calculated using the Kurtzke Expanded Disability Status Scale (EDSS) lower than 7; * Acceptable level of digital skills; * The presence of the caregiver. Exclusion Criteria: * Other conditions that may affect motor function; * Impaired cognitive functioning (Mini-Mental Status Examination \<24/30); * Severe visual deficits (daltonism and visual acuity deficit); * Unable or refused to attend the rehabilitation treatment. Patients who fulfill the following specified inclusion criteria will also undergo an EEG evaluation. However, ineligibility for this examination does not exclude them from participating in the rehabilitation study. The inclusion criteria for the EEG protocol will include: * The absence of metallic implants in the brain; * No history of brain surgery; * No use of medications that alter cortical excitability or are presumed to affect brain plasticity; * Right-handed dominance.
- Verona, Italy