Mixed Reality for Upper Limb Rehabilitation in People With Multiple Sclerosis (VIRTUALDOMUS)

NCT06968676 | Recruiting

• 1 other identifier: UniversidadRJC2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Multiple Sclerosis

Keywords

Multiple sclerosis; Mixed reality; Upper limb; Rehabilitation; Manipulative skills; Functionality; Quality of life

Outcome Measures

Primary Outcomes (1)

• Isometric prehensile hand strength (Kg)

  Isometric prehensile hand strength: measured by the JAMAR® fist dynamometer. The JAMAR® dynamometer has been widely cited and is considered the gold standard for the assessment of fist strength. Three measurements of the maximum voluntary maximum isometric contraction (MVC) will be taken with each hand, always starting with the least affected hand; once the three measurements have been taken, the mean of these will be obtained. Major values (Kg) means a higher hand grip strengh (there is not a maximum).

  Up to 10 weeks

Secondary Outcomes (6)

• Isometric pincer force (Kg)

  Up to 10 weeks

• Gross coordination for the upper limb (Block and Box; number of cubes)

  Up to 10 weeks

• Fine coordination for the upper limb (NHPT; time in seconds)

  Up to 10 weeks

• Functional status of the upper limb (ABILHAND)

  Up to 10 weeks

• Quality of life (MSIS-29)

  Up to 10 weeks

Study Arms (2)

Conventional upper limb training

ACTIVE COMPARATOR

Conventional physical therapy exercises for the upper limb, including joint mobilization of the shoulder, elbow, wrist and fingers, forearm and hand muscle strengthening exercises, gross and fine motor work and functional task practice with the aim of mimicking the movements included in the settings specifically designed for experimental intervention

Other: Conventional Upper Limb Treatment

Mixed reality

EXPERIMENTAL

The experimental group will receive the same conventional physiotherapy treatment plus an extended reality protocol, using Meta Quest 3.0. glasses, by retraining on tasks specifically designed for this project and linked to the specific locations (kitchen, bathroom, living room, bedroom and garden-terrace; see Annexes, page 2, "Recommendations on the development of mixed reality environments"). The intervention will be carried out by a physiotherapist skilled in the use of the technology. The patient's initial position will be seated in front of a table at mid-trunk height, with the elbow at 90° of flexion and the forearm in neutral pronation-supination. The therapist will provide manual assistance as needed, moving to upright sitting or standing positions as the protocol progresses and as tasks require, and work will be done bilaterally.

Other: Experimental intervention with mixed reality

Interventions

Conventional Upper Limb Treatment OTHER

Control group (CG) will receive two 60-minute sessions per week for a period of ten weeks (a total of 20 sessions per group). The CG will receive a specific conventional physiotherapy intervention by a physiotherapist with expertise in the care of people with MS. This intervention will be based on conventional physiotherapy exercises \[23\], including shoulder, elbow, wrist and finger joint mobilization, forearm and hand muscle strengthening exercises, gross and fine motor work and functional task practice with the aim of mimicking the movements included in the settings specifically designed for the experimental intervention.

Conventional upper limb training

Experimental intervention with mixed reality OTHER

Experimental group will receive the same conventional physiotherapy treatment (40 minutes) in addition to a mixed reality protocol, using Meta Quest 3.0. glasses (20 minutes), by retraining on tasks specifically designed for this project and linked to the specific locations (kitchen, bathroom, living room, bedroom and garden-terrace. The intervention will be carried out by a physiotherapist skilled in the use of the technology. The patient's initial position will be seated facing a table at mid-trunk height, with the elbow at 90° of flexion and the forearm in neutral pronation-supination. The therapist will provide manual assistance as needed, moving to upright-high seated or standing positions as the protocol progresses and as tasks require, and work will be done bilaterally.

Mixed reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Asociación de Leganés de Esclerosis Múltiple

Leganés, Madrid, 28918, Spain

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Roberto Cano de la Cuerda, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Cano de la Cuerda, PhD

CONTACT

+34914888674; roberto.cano@urjc.es

Selena Marcos Antón, PhD

CONTACT

selena.marcos@villanueva.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator who will randomize the sample will be external to any intervention. The evaluators will be external to any intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD. Full Professor

Model Details: Rehabilitation treatment. We do not use drugs or vaccines.

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)