IVR in Motor Rehabilitation

NCT05364970 | Recruiting Early Phase 1

• 1 other identifier: 1234
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The present project on sport rehabilitation aims at validating a rehabilitation protocol in immersive virtual reality (IVR) for restoring motor functions following peripheral injuries of the lower limbs. Sport injuries are related to direct and indirect costs and, in many cases, cause an interruption of motor activity for prolonged periods. Sport physiotherapy aims at recovering the motor functionality in order to guarantee the fastest possible return to sport. It employs plasticity and compensatory mechanisms within the injured motor system. However, being primarily based on the execution of movements that can be largely compromised, the treatment might be intrinsically complicated. It has been suggested that the motor system can be activated by observing one's own body perform the movements, without any actual movement execution. By using multisensory integration and sense of presence in IVR, it is possible to create an illusory experience that a moving virtual body (avatar) temporarily becomes one's own moving body. Moreover, this experience activates the motor system similarly to the activation from one's own actual movements. Based on these considerations, the present study hypothesizes that observation of one's own virtual body, without any movement execution, might activate the motor system to the extent of significantly improving functional recovery. The randomized clinical trial will recruit participants that underwent knee surgery and are in the first phase of the rehabilitation period (starting within two weeks after the surgery). Together with the traditional training protocol (4-6 weeks) participants will be administered a training in IVR that will include a virtual avatar performing a series of standard lower limb rehabilitation exercises. Participants will be randomly assigned to the experimental group (avatar observed from the first-person perspective, i.e., perceived as one's own body), the active control group (avatar observed from the third-person perspective, i.e., perceived as another person's body) and the group with no intervention. Before, at midpoint and after intervention, a standard battery of tests will be administered to evaluate the state of the motor system), as well as measures of embodiment for controlling the efficacy of the virtual scenario. The hypothesis is that the experimental group will show greater improvement of the motor functionality compared to the two control groups.

Conditions

Knee Injuries

Keywords

Knee reconstruction; Immersive virtual reality; Full body illusion; Motor rehabilitation

Outcome Measures

Primary Outcomes (5)

• Change of the IKDC scale score from pre-training to post-training

  International knee documentation committee subjective knee evaluation form; scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  T0 (Before VR training sessions), T1 (After 50% of VR training sessions, week 3), T2 (After 100% of VR training sessions, week 6)

• Change of the joint position sense measure from pre-training to post-training

  Joint position sense measured with GyKo (inertial measurement tool)

  T0 (Before VR training sessions), T1 (After 50% of VR training sessions, week 3), T2 (After 100% of VR training sessions, week 6)

• Embodiment questionnaire pre-training

  Measure of subjective experience of body ownership/agency in the VR scenario on a visual analogue scale; min = 1, max = 10, where lower scores indicate absence of/weaker illusion of embodiment and higher scores indicate stronger illusion of embodiment

  T0 (Before VR training sessions)

• Embodiment questionnaire mid-training

  Measure of subjective experience of body ownership/agency in the VR scenario on a visual analogue scale; min = 1, max = 10, where lower scores indicate absence of/weaker illusion of embodiment and higher scores indicate stronger illusion of embodiment

  T1 (After 50% of VR training sessions, week 3)

• Embodiment questionnaire post-training

  Measure of subjective experience of body ownership/agency in the VR scenario on a visual analogue scale; min = 1, max = 10, where lower scores indicate absence of/weaker illusion of embodiment and higher scores indicate stronger illusion of embodiment

  T2 (After 100% of VR training sessions, week 6)

Secondary Outcomes (6)

• Change of the knee extension measure from pre-training to post-training

  T0 (Before VR training sessions), T1 (After 50% of VR training sessions, week 3), T2 (After 100% of VR training sessions, week 6)

• Change of maximal force of the knee extensors from pre-training to post-training

  T0 (Before VR training sessions), T1 (After 50% of VR training sessions, week 3), T2 (After 100% of VR training sessions, week 6)

• Change of subjective level of pain after maximal contraction from pre-training to post-training

  T0 (Before VR training sessions), T1 (After 50% of VR training sessions, week 3), T2 (After 100% of VR training sessions, week 6)

• Subjective feedback regarding the IVR experience pre-training

  T0 (Before VR training sessions)

• Subjective feedback regarding the IVR experience mid-training

  T1 (After 50% of VR training sessions, week 3)

Study Arms (3)

VR_1PP

EXPERIMENTAL

Virtual training with an avatar observed from the first-person perspective

Combination Product: VR_Training_1PP

VR_3PP

ACTIVE COMPARATOR

Virtual training with an avatar observed from the third-person perspective

Combination Product: VR_Training_3PP

NO_VR

NO INTERVENTION

No VR training administered

Interventions

VR_Training_1PP COMBINATION_PRODUCT

Immersive VR scenario of physical training with avatar embodiment

VR_1PP

VR_Training_3PP COMBINATION_PRODUCT

Immersive VR scenario of physical training without avatar embodiment

VR_3PP

Eligibility Criteria

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

You may qualify if:

• Early recovery after knee sprain and/or surgery to knee ligaments and/or meniscus after musculoskeletal injuries of the knee
• Normal or corrected-to-normal visual acuity

You may not qualify if:

• History of neurological or psychiatric disorders
• Motion sickness during IVR use

Sponsors & Collaborators

• University of Turin, Italy: lead
• HastaFisio - Fisioterapia e Medicina dello Sport: collaborator

Study Sites (1)

University of Turin

Turin, TO, 10124, Italy

RECRUITING

Related Publications (11)

• Burin D, Pyasik M, Salatino A, Pia L. That's my hand! Therefore, that's my willed action: How body ownership acts upon conscious awareness of willed actions. Cognition. 2017 Sep;166:164-173. doi: 10.1016/j.cognition.2017.05.035. Epub 2017 May 31.

  PMID: 28577446 RESULT

• Cumps E, Verhagen E, Annemans L, Meeusen R. Injury rate and socioeconomic costs resulting from sports injuries in Flanders: data derived from sports insurance statistics 2003. Br J Sports Med. 2008 Sep;42(9):767-72. doi: 10.1136/bjsm.2007.037937. Epub 2007 Nov 29.

  PMID: 18048438 RESULT

• Ekstrand J, Walden M, Hagglund M. Hamstring injuries have increased by 4% annually in men's professional football, since 2001: a 13-year longitudinal analysis of the UEFA Elite Club injury study. Br J Sports Med. 2016 Jun;50(12):731-7. doi: 10.1136/bjsports-2015-095359. Epub 2016 Jan 8.

  PMID: 26746908 RESULT

• Maselli A, Slater M. The building blocks of the full body ownership illusion. Front Hum Neurosci. 2013 Mar 21;7:83. doi: 10.3389/fnhum.2013.00083. eCollection 2013.

  PMID: 23519597 RESULT

• Pyasik M, Salatino A, Burin D, Berti A, Ricci R, Pia L. Shared neurocognitive mechanisms of attenuating self-touch and illusory self-touch. Soc Cogn Affect Neurosci. 2019 Feb 13;14(2):119-127. doi: 10.1093/scan/nsz002.

  PMID: 30649514 RESULT

• Pyasik M, Ronga I, Burin D, Salatino A, Sarasso P, Garbarini F, Ricci R, Pia L. I'm a believer: Illusory self-generated touch elicits sensory attenuation and somatosensory evoked potentials similar to the real self-touch. Neuroimage. 2021 Apr 1;229:117727. doi: 10.1016/j.neuroimage.2021.117727. Epub 2021 Jan 9.

  PMID: 33434613 RESULT

• Rossetti, Y., Rode, G., & Goldenberg, G. (2005). Perspectives in higher-order motor deficits rehabilitation: Which approach for which ecological result? In H. J. Freund, M. Jeannerod, M. Hallett, & R. Leiguarda (Eds.), Higher-order motor disorders: From neuroanatomy and neurobiology to clinical neurology (pp. 475-497). Oxford University Press.

  RESULT

• Tambone R, Giachero A, Calati M, Molo MT, Burin D, Pyasik M, Cabria F, Pia L. Using Body Ownership to Modulate the Motor System in Stroke Patients. Psychol Sci. 2021 May;32(5):655-667. doi: 10.1177/0956797620975774. Epub 2021 Apr 7.

  PMID: 33826456 RESULT

• Whatman C, Hing W, Hume P. Physiotherapist agreement when visually rating movement quality during lower extremity functional screening tests. Phys Ther Sport. 2012 May;13(2):87-96. doi: 10.1016/j.ptsp.2011.07.001. Epub 2011 Aug 27.

  PMID: 22498149 RESULT

• Winstein, C. J., & Wolf, S. L. (2008). Task-oriented training to promote upper extremity recovery. In J. Stein, R. Harvey, R. Macko, C. J. Winstein, & R. Zorowitz (Eds.), Stroke recovery and rehabilitation (pp. 267-290). Demos Medical Publishing.

  RESULT

• Pyasik M, Furlanetto T, Pia L. The Role of Body-Related Afferent Signals in Human Sense of Agency. J Exp Neurosci. 2019 May 16;13:1179069519849907. doi: 10.1177/1179069519849907. eCollection 2019.

  PMID: 31205423 RESULT

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Lorenzo Pia, PhD

  University of Turin, Italy

  STUDY CHAIR

• Maria Pyasik, PhD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

• Gennaro Boccia, PhD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Pia, PhD

CONTACT

011 6703922; lorenzo.pia@unito.it

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 6, 2022
• Study Start: April 12, 2023
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available together with the publication of preprint/article reporting the results of the study.
• Access Criteria: The data will be freely available.

Locations

IT (1)