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Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 9, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Apr 2025 to Sep 2026 Start date: Apr 6, 2023 to Nov 2, 2023 · Completion date: Jul 2025 to Dec 2026 · Site details revisedv4 Show 3 more changesShow less
    • Start date: Apr 6, 2023 to Nov 2, 2023
    • Completion date: Jul 2025 to Dec 2026
    • Site details revised
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2023 to Apr 6, 2023 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Mar 2023 to Apr 6, 2023
    • Site details revised
  3. Minor Secondary endpoints: details revised at 10 of 18 entriesv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Action Observation Treatment (AOT) is a rehabilitative strategy which has been proposed as a promising approach to improve motor performance in neurological conditions, including multiple sclerosis (MS). In this clinical trial, the investigators aim to explore the role of a home-based AOT with virtual reality (VR) in improving upper limb motor function in people with MS (PwMS). The objectives are: * To compare the effects of home-based VR-AOT versus VR-landscape observation (LO) on upper limb motor performance; * To measure brain network functional changes (functional plasticity) and structural variations of gray matter (GM) and white matter (WM) (structural plasticity) using advanced magnetic resonance imaging (MRI) techniques following VR-AOT and VR-LO; * To study the correlations between MRI changes and clinical improvements and the predictors of VR-AOT efficacy. All participants will undergo treatment sessions for 3 weeks (5 consecutive days/week, total=15 sessions lasting 30 minutes each). Those in the VR-AOT group will observe, imagine and execute two upper limb motor tasks in each session. Those in the VR-LO group will perform the same tasks, but they will observe inanimate landscapes beforehand instead.
Trial Details
NCT Number NCT05713890
Lead Sponsor IRCCS San Raffaele
Collaborators: Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Conditions Multiple Sclerosis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov