Ireland
--:--IST
Active, not recruiting Not applicable

Virtual Reality Therapy for Arm Recovery (VVITA) Stroke

NCT07103122 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2022-03-01
Last updated
2025-08-05

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

Experimental GroupControl Group

Experimental Group: A Personalized Adaptive Mirror Therapy for Upper-Limb Post-Stroke Rehabilitation using Virtual Reality and Myoelectric Control for 24 sesion in 8 weeks in add on to standard therapy.

Control Group: Conventional Therapy

Study summary

The study exploits new technologies appeared in the consumer electronics market to provide stroke patients with a low-cost, easy-to-use upper limb rehabilitation tool based on virtual reality. It aims to assess the potential, validity and participation in therapy while using virtual reality to improve limb rehabilitation through rehabilitation exercises that will use games chosen to improve the capabilities of the paretic upper limb. This therapy will be administered in addition to normal therapy and will be compared with a control group that will carry out the regular conventional therapy plus a neuromotor therapy dedicated to the upper limb of equal time and dose of interventional therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
1. Individuals affected by stroke with upper limb deficits with sufficient level of muscle power, so that movement is possible with gravity eliminated (F=2), or muscle movement is possible against gravity (F=3), as assessed with Medical Research Council (MRC) scale grades not below 1 2. havinge reported at least 18 but not more than 54 out of 66, respectively 27% and 80% of the upper limb functionality, as assessed with the Upper Limb Extremity section of the Fugl-Meyer Assessment (FMA) scale 3. not having e reportedabsence of severe linguistic impairments which may limit the understanding of the instructions; 4. not having e reportedabsence of cognitive impairments, assessed with the Addenbrooke's Cognitive Examination - Revised version for Italian population, visual deficit or other neurologic disease in comorbidity, which may affect the patient's ability to interact with the VR environment.

Primary outcome measure(s)

  • Motor procifiency assessed with FMA - UE — FMA - UE will be used for the initial evaluation of patients (Day 1), the intermediate one (Day 30) and at the end (Day 60).
    The Fugl-Meyer Assessment Upper Extremity Scale (FMA-UE) is a widely recognized and utilized clinical tool designed to evaluate motor function, sensory function, balance, and joint range of motion in individuals who have experienced a stroke or other neurological impairments. The FMA-UE specifically focuses on the upper extremity, assessing the recovery of motor skills and coordination following neurological injuries.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Fondazione Santa Lucia Roma Roma
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07103122 on ClinicalTrials.gov ↗ ← All trials in Italy