Actively Recruiting
Mixed Reality for Upper Limb Rehabilitation in People With Multiple Sclerosis (VIRTUALDOMUS)
Led by Universidad Rey Juan Carlos · Updated on 2026-05-05
30
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Although virtual reality has attracted the attention of health professionals and neurorehabilitation field, research about mixed reality (MR) in people with neurological disorders, particularly multiple sclerosis (MS), is very limited. Furthermore, to our knowledge, studies about the effects of MR in upper limb (muscle strength and fatigability, coordination and dexterity, functionality and quality of life) in people with MS are nonexistent. The main objective of our study are: To know the clinical effects of mixed reality environments and re-training activities linked to their spaces (kitchen, bathroom, living room, bedroom and terrace-garden), designed for the treatment of upper limb impairments in people with MS, in combination with a conventional physiotherapy program, on manipulative skills, functionality and quality of life in people with MS. The secundary objectives are: To study the clinical effects on range of motion, muscle strength, coordination and manual dexterity, fatigue, functionality and quality of life in people with MS. To analyze satisfaction and adherence to treatment, the occurrence of adverse effects and the level of workload perceived by participants. A double-blind randomized controlled trial is proposed. The sample will be randomly divided into two groups: the experimental group will receive treatment based on mixed reality for MMSS, designed by the research team and using Meta Quest 3.0 glasses, in combination with conventional physiotherapy; and the control group will receive the same conventional therapy. Both groups will receive 2 sessions/week, 60min/session, for 10 weeks. The mixed reality environments to be designed will be a kitchen, a bathroom, a living room, a bedroom and a terrace-garden, with the tasks to be performed in each location. The pre, post-treatment and one-month follow-up outcome measures will be: range of motion, manual grip strength, manual dexterity, fatigue, functionality, quality of life, satisfaction with the technology, adherence, adverse effects and perceived workload. A statistical comparison study will be carried out establishing as an inter-subject factor the group parameter and as intra-subject factors each of the measurements and the treated side.
CONDITIONS
Official Title
Mixed Reality for Upper Limb Rehabilitation in People With Multiple Sclerosis (VIRTUALDOMUS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years of age
- Diagnosis of multiple sclerosis for more than two years
- Disability status scale score between 2.0 and 7.0
- Stable medical treatment for at least six months before the study
- Upper limb muscle tone no greater than 2 on the modified Ashworth Scale
- Muscle strength of 3 or higher in the upper limbs
- Pyramidal function score of 4 or less
- No cognitive impairment and able to understand instructions with a Minimental Test score of 24 or more
- Mental functions score of 2 or less on the EDSS scale
You will not qualify if you...
- Diagnosis of neurological or musculoskeletal disorders other than multiple sclerosis
- Cardiovascular, respiratory, metabolic, or other diseases that could affect study participation
- MS exacerbation or hospitalization within 3 months before or during the study
- Steroid treatment within 6 months before or during the study
- Botulinum toxin treatment within 6 months before the study
- Muscle tone score higher than 2 on the modified Ashworth Scale
- Cognitive or language impairments preventing communication or understanding
- Uncorrected visual problems or history of photosensitive epilepsy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Asociación de Leganés de Esclerosis Múltiple
Leganés, Madrid, Spain, 28918
Actively Recruiting
Research Team
R
Roberto Cano de la Cuerda, PhD
CONTACT
S
Selena Marcos Antón, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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