Status:
NOT_YET_RECRUITING
Telerehabilitation in Progressive Multiple Sclerosis
Lead Sponsor:
Universita di Verona
Collaborating Sponsors:
Università degli Studi di Ferrara
Conditions:
Progressive Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 mana...
Detailed Description
The literature emphasizes a striking dearth of studies devoted solely to people with SPMS or PPMS and the lack of ecological validity in assessing the results. This suggests that an additional effort ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06485115
Start Date
June 30 2024
End Date
June 30 2026
Last Update
July 3 2024
Active Locations (1)
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1
Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
Verona, Italy, 37131