Multiple Sclerosis Clinical Trial
Official title:
Innovative Low-cost Solutions Based on Virtual Reality for Upper Limb Home-based Rehabilitation in Multiple Sclerosis
This study is aimed to test the efficacy and feasibility of an immersive virtual reality (VR)
rehabilitation programs to improve upper-limb motor functions in 24 patients with multiple
sclerosis (pwMS), characterized by moderate to severe upper-limb motor dysfunctions. In
particular, this study will evaluate the efficacy of VR as novel opportunities to increase
treatment engagement and rehabilitation effects.
The effectiveness of the rehabilitation program will be assessed using both clinical tests
and state-of-the art motion capture system for human movement analysis.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | June 3, 2022 |
Est. primary completion date | June 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > 18 - Definite MS diagnosis, sub-type Relapsing-Remitting or Secondary Progressive - Clinically stable - No relapses at the time of the enrolment in the study - Able to understand the informed consent process and provide consent to participate in the study - 9-Hole Peg Test score > 30 seconds Exclusion Criteria: - Relapses occurring over the past 3 months - History of seizures - Severe blurred vision - Concomitant auditory and vestibular deficits - Presence of other neurological, orthopaedic (non-MS related), psychiatric or cognitive impairments that would interfere with the execution of the study |
Country | Name | City | State |
---|---|---|---|
Italy | Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari | Monserrato | Cagliari |
Lead Sponsor | Collaborator |
---|---|
University of Cagliari | Azienda Sanitaria Locale di Cagliari, Fondazione Don Carlo Gnocchi Onlus, Italian Multiple Sclerosis Foundation |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in box and block score | The Box and Block Test measures unilateral gross manual dexterity. Score consists of the number of blocks transferred from one compartment to the other compartment in 60 seconds (score each hand separately). Higher values indicate better performance. Reference value for unaffected population is 55 blocks/min. |
Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2) | |
Secondary | Change in Nine-Hole Peg score | The Nine-Hole Peg Test measures finger dexterity. Score consists of the time to place and remove one by one the holes on the board, as quickly as possible. Higher values indicate worse performance. | Baseline (T0), immediately after the end of the treatment (+4 weeks, T1), +8 weeks from the baseline (T2) |
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