Status:
UNKNOWN
Upper Limb Telerehabilitation With Virtual Reality in Multiple Sclerosis
Lead Sponsor:
University of Cagliari
Collaborating Sponsors:
Azienda Sanitaria Locale di Cagliari
Tel Aviv University
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
25-60 years
Phase:
NA
Brief Summary
This study aims to investigate the effectiveness of a home-based telerehabilitation program specifically designed for upper limbs, based on Virtual Reality (VR) in individuals affected by Multiple Scl...
Detailed Description
Approximately 60% of people with multiple sclerosis (pwMS) suffer from upper limb dysfunction. The primary goal of this study is to implement a single-blind, randomized control trial (RCT) designed to...
Eligibility Criteria
Inclusion
- diagnosis of MS according to the revised McDonald Criteria 2017;
- aged 25-60 years old;
- an Expanded Disability Status Scale score ≥6;
- an ability to understand and execute simple instructions;
- a cut-off score of \>0.5 pegs/s(=18s) on the NHPT (selected due to its high discriminative and predictive ability in distinguishing ADL independence in pwMS).
Exclusion
- orthopedic and other neurological disorders affecting upper limb movements (e.g., epileptic seizures);
- contra-indication to physical activity (e.g., heart failure, severe osteoporosis);
- moderate or severe cognitive impairments as indicated by the Mini-Mental State Examination score \<21;
- pregnancy (self-reported);
- severe uncorrected visual deficits;
- MS clinical relapse or treatment with corticosteroid therapy within 90 days prior to enrollment;
- started or stopped a disease-modifying therapy for MS within 90 days prior to enrollment;
- patients who received a course of physical or occupational therapy (home, outpatient or inpatient) within the past 30 days;
- other treatments that could influence the effects of the interventions
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04032431
Start Date
December 1 2020
End Date
September 1 2022
Last Update
March 24 2020
Active Locations (2)
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1
The Multiple Sclerosis Center, Sheba Medical Center
Tel Litwinsky, Israel
2
Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari
Monserrato, Cagliari, Italy, 09042