Mixed reality therapy for improving arm and hand function in people with multiple sclerosis
Effects of Mixed Reality on Manipulative Skills, Functionality and Quality of Life in People With Multiple Sclerosis. A Randomized Controlled Trial (VIRTUAL-DOMUS)
This trial will try mixed‑reality training combined with conventional physiotherapy to improve upper‑limb strength, coordination, dexterity, and daily function in adults with multiple sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Rey Juan Carlos Academic / other |
| Locations | 1 site (Leganés, Madrid) |
| Trial ID | NCT06968676 on ClinicalTrials.gov |
What this trial studies
Participants receive a conventional upper‑limb physiotherapy program with or without additional mixed‑reality training set in everyday environments such as a kitchen, bathroom, living room, bedroom, and terrace‑garden. The mixed‑reality sessions are designed to retrain manipulative skills, muscle strength, coordination, dexterity, range of motion, and fatigability through repeated functional tasks with feedback. Outcomes include measures of manipulative skills, upper‑limb functionality, quality of life, muscle strength, coordination, manual dexterity, range of motion, and fatigue. The trial enrolls adults with MS (disease duration >2 years) with EDSS scores of 2.0 to 7.0 and requires stable medication and preserved upper‑limb strength and tone for safe participation.
Who should consider this trial
Good fit: Adults with multiple sclerosis for more than two years, EDSS 2.0–7.0, stable medications for at least six months, upper‑limb muscle tone ≤2 on the modified Ashworth Scale, and muscle strength ≥3 are the best candidates.
Not a fit: People with very advanced disability (EDSS >7.0), severe spasticity or very weak upper limbs, unstable medical treatment, or cognitive/visual problems that prevent using mixed‑reality equipment are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could improve arm and hand function and quality of life by making rehabilitation more engaging and task‑specific.
How similar studies have performed: While virtual reality interventions have shown promise in neurological rehabilitation, mixed reality specifically for upper‑limb rehabilitation in MS is largely untested and this protocol is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -\>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 Criteria: * 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.
Where this trial is running
Leganés, Madrid
- Asociación de Leganés de Esclerosis Múltiple — Leganés, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Roberto Cano de la Cuerda, PhD — Universidad Rey Juan Carlos
- Study coordinator: Roberto Cano de la Cuerda, PhD
- Email: roberto.cano@urjc.es
- Phone: +34914888674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.