Virtual Reality Therapy for Arm Recovery (VVITA) Stroke

NCT07103122 | Active Not Recruiting

• 1 other identifier: FSLVVITACE790
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Virtual Reality; Mirror Therapy; Arm Recovery; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Motor procifiency assessed with FMA - UE

  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.

  FMA - UE will be used for the initial evaluation of patients (Day 1), the intermediate one (Day 30) and at the end (Day 60).

Secondary Outcomes (2)

• Kinematic Assessment

  Kinematic assessment was performed for the initial evaluation of patients (Day 1), the intermediate one (Day 30) and at the end (Day 60).

• Gesture Assessment

  This assessment was done for all the patients at the initial evaluation (Day 1), the intermediate (Day 30) and at the end (Day 60).

Other Outcomes (1)

• Usability Assessment

  This assessment was done only for Experimental Group at different stages at the beginning (Day 1) and at the end of the protocol (Day 60).

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The control group followed a specific physiotherapy treatment for the upper limb in add-on to the conventional treatment. This consisted in training the patients in reaching and grasping tasks like those followed by the experimental group, but in the absence of visual stimuli or physical objects. 24 sesion in 8 weeks in add on to standard therapy.

Other: Control Group

Experimental Group

EXPERIMENTAL

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.

Other: Experimental Group

Interventions

Experimental Group OTHER

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.

Experimental Group

Control Group OTHER

Conventional Therapy

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead
• DLR German Aerospace Center: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator
• University of Rome Tor Vergata: collaborator
• University of Roma La Sapienza: collaborator
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator
• IRCCS Centro Neurolesi Bonino Pulejo: collaborator
• University of L'Aquila: collaborator

Study Sites (1)

IRCCS Fondazione Santa Lucia

Roma, Roma, 00179, Italy

Location

Related Publications (11)

• Gil-Gomez JA, Manzano-Hernandez P, Albiol-Perez S, Aula-Valero C, Gil-Gomez H, Lozano-Quilis JA. USEQ: A Short Questionnaire for Satisfaction Evaluation of Virtual Rehabilitation Systems. Sensors (Basel). 2017 Jul 7;17(7):1589. doi: 10.3390/s17071589.

  PMID: 28686174 BACKGROUND

• Foley N, Pereira S, Salter K, Meyer M, McClure JA, Teasell R. Are recommendations regarding inpatient therapy intensity following acute stroke really evidence-based? Top Stroke Rehabil. 2012 Mar-Apr;19(2):96-103. doi: 10.1310/tsr1902-96.

  PMID: 22436357 BACKGROUND

• Dong Y, Liu X, Tang M, Huo H, Chen D, Du X, Wang J, Tang Z, Qiao X, Guo J, Fan L, Fan Y. Age-related differences in upper limb motor performance and intrinsic motivation during a virtual reality task. BMC Geriatr. 2023 Apr 27;23(1):251. doi: 10.1186/s12877-023-03970-7.

  PMID: 37106330 BACKGROUND

• DiCicco, M., Lucas, L. & Matsuoka, Y. Comparison of control strategies for an EMG controlled orthotic exoskeleton for the hand. In IEEE International Conference on Robotics and Automation, 2004. Proceedings. ICRA '04. 2004 1622-1627 Vol.2

  BACKGROUND

• d'Avella A, Portone A, Fernandez L, Lacquaniti F. Control of fast-reaching movements by muscle synergy combinations. J Neurosci. 2006 Jul 26;26(30):7791-810. doi: 10.1523/JNEUROSCI.0830-06.2006.

  PMID: 16870725 BACKGROUND

• Cramer SC, Nelles G, Benson RR, Kaplan JD, Parker RA, Kwong KK, Kennedy DN, Finklestein SP, Rosen BR. A functional MRI study of subjects recovered from hemiparetic stroke. Stroke. 1997 Dec;28(12):2518-27. doi: 10.1161/01.str.28.12.2518.

  PMID: 9412643 BACKGROUND

• Clark DJ, Ting LH, Zajac FE, Neptune RR, Kautz SA. Merging of healthy motor modules predicts reduced locomotor performance and muscle coordination complexity post-stroke. J Neurophysiol. 2010 Feb;103(2):844-57. doi: 10.1152/jn.00825.2009. Epub 2009 Dec 9.

  PMID: 20007501 BACKGROUND

• Cheung VC, Turolla A, Agostini M, Silvoni S, Bennis C, Kasi P, Paganoni S, Bonato P, Bizzi E. Muscle synergy patterns as physiological markers of motor cortical damage. Proc Natl Acad Sci U S A. 2012 Sep 4;109(36):14652-6. doi: 10.1073/pnas.1212056109. Epub 2012 Aug 20.

  PMID: 22908288 BACKGROUND

• Cheung VC, Piron L, Agostini M, Silvoni S, Turolla A, Bizzi E. Stability of muscle synergies for voluntary actions after cortical stroke in humans. Proc Natl Acad Sci U S A. 2009 Nov 17;106(46):19563-8. doi: 10.1073/pnas.0910114106. Epub 2009 Oct 30.

  PMID: 19880747 BACKGROUND

• Cecchi F, Carrabba C, Bertolucci F, Castagnoli C, Falsini C, Gnetti B, Hochleitner I, Lucidi G, Martini M, Mosca IE, Pancani S, Paperini A, Verdesca S, Macchi C, Alt Murphy M. Transcultural translation and validation of Fugl-Meyer assessment to Italian. Disabil Rehabil. 2021 Dec;43(25):3717-3722. doi: 10.1080/09638288.2020.1746844. Epub 2020 May 1.

  PMID: 32356509 BACKGROUND

• Bizzi E, Cheung VC, d'Avella A, Saltiel P, Tresch M. Combining modules for movement. Brain Res Rev. 2008 Jan;57(1):125-33. doi: 10.1016/j.brainresrev.2007.08.004. Epub 2007 Sep 5.

  PMID: 18029291 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Andrea d'Avella, PhD, Full Professor

  1) Laboratory of Neuromotor Physiology, IRCCS Fondazione Santa Lucia, Rome, Italy; 2)Department of Biology, University of Rome Tor Vergata, Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pilot Randomized Controlled Trial

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 5, 2025
• Study Start: March 1, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)