Status:
NOT_YET_RECRUITING
Mixed Reality for Upper Limb Rehabilitation in People With Multiple Sclerosis (VIRTUALDOMUS)
Lead Sponsor:
Universidad Rey Juan Carlos
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Although virtual reality has attracted the attention of health professionals and neurorehabilitation field, research about mixed reality (MR) in people with neurological disorders, particularly multip...
Detailed Description
MS is a neurological pathology that currently affects approximately 36 people per 100,000 inhabitants (2.8 million people affected in the world) and has various clinical manifestations, such as altera...
Eligibility Criteria
Inclusion
- \>18 years of age.
- Diagnosis of MS according to McDonald criteria (53) with a time of evolution longer than two years.
- Assessment on the Kurtzke Multiple Sclerosis Disability Status Scale (EDSS) with a score between 2. 0 (minimal disability in one section of the FS (at least one with a score of 2).) to 7.0 (unable to walk more than a few steps, even with assistance, basically confined to wheelchair and able to transfer from wheelchair to another place, or can manage to go to the toilet for 12 hours a day) .
- Stable medical treatment for at least six months prior to surgery.
- Upper extremity muscle tone no greater than 2 points (moderate hypertonia, increased muscle tone during most of the arc of motion, but can passively move the affected part with ease) on the modified Ashworth Scale.
- Muscle balance equal to or greater than 3 in the upper extremity.
- Score less than or equal to 4 points on the "Pyramidal Function" section of the EDSS functional scale.
- Absence of cognitive impairment, with ability to understand instructions and score equal to or greater than 24 on the Minimental Test.
- A- score equal to or less than 2 points on the "Mental Functions" section of the EDSS.
Exclusion
- Diagnosis of a neurological disease or musculoskeletal disorder other than MS.
- Diagnosis of a cardiovascular, respiratory or metabolic disease or other conditions that may interfere with this study.
- Having suffered an exacerbation or hospitalization in the last 3 months before starting the assessment protocol, or during the therapeutic intervention process.
- Having received a course of steroids, intravenous or oral, 6 months prior to the start of the assessment protocol and within the intervention period of the study duration.
- Having received treatment with botulinum toxin in the 6 months prior to the start of the study.
- A score higher than 2 points on the modified Ashworth scale.
- Cognitive or language impairment that prevents adequate communication or comprehension.
- The presence of visual disturbances not corrected by ocular devices; or a history of photosensitive epilepsy.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06968676
Start Date
September 1 2025
End Date
December 31 2027
Last Update
May 16 2025
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