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

Study acronym: VIRTUALDOMUS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  2. Minor Study title shortened, about 4 wordsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06968676
Lead Sponsor Universidad Rey Juan Carlos
Conditions
(from sponsor)
Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov