Knee InjuriesEarly Phase 1IVR_MOTNCT05364970
IVR in Motor Rehabilitation
A Early Phase 1 study testing VR_Training_1PP and VR_Training_3PP in people with Knee Injuries, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- VR_Training_1PP and VR_Training_3PP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2023to 1 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of neurological or psychiatric disorders
- Motion sickness during IVR use
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Turin
Turin, TO, 10124
Lorenzo Pia, PhD, 011 6703922 ext. +39, lorenzo.pia@unito.it
Maria Pyasik, PhD
About this study
Official title: Immersive Virtual Reality in the Rehabilitation of Peripheral Injuries
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.
Read the detailed description
BACKGROUND Sport injuries are an important obstacle both for sport performance and for maintaining a healthy lifestyle that implies continuous and regular physical activity. In Italy, each year there are approximately 300.000 admissions to the ER among 20 millions of people practicing sports.
As regards competitive sport, dense competition schedules, fast-paced rhythms and growing pressure experienced by athletes determine the increasing frequency of injuries. Injuries result in periods of refrain from competitions and affects athletes' psycho-physical balance. For these reasons, sport injuries have significant direct and indirect costs and physiotherapy aims to recover motor function to guarantee the fastest and safest return to sport.
Any form of motor rehabilitation, both in cases of damage to the central nervous system and those related to peripheral problems (as in the majority of sport injuries), is based on the concepts of plasticity and compensation. In other words, the possibility of recovery implies that the system can reorganize itself. In practical terms, rehabilitation science in its current form attempts to directly promote active and repetitive exercise of the damaged (motor) system. This logic, i.e., the process that is primarily based on action execution, has a major intrinsic limit that poses an obstacle for the treatment: it works directly with the motor functioning that is, however, compromised, even to a severe extent. However, it has been recently suggested that the motor system can be activated by simply observing one's own body perform the movements, without any actual movement execution. In line with that, and taking advantage of the multisensory nature and the sense of presence and embodiment that Immersive virtual reality (IVR) provides, it has been shown that it is possible to create an illusory experience that a moving virtual body (avatar) temporarily became one's own moving body (so-called embodiment. Moreover, this experience activates the motor system in a way similar to the activation from one's own actual movements. Therefore, in such conditions, the (illusory) movements of the embodied virtual body are integrated in the participant's motor system.
Based on these theoretical considerations, the present project proposes to employ the IVR to test a possible drastic change to the rehabilitation approach that would bypass/limit the problem of the (deficient) motor execution. The main hypothesis is that simple observation of a moving virtual body, which is perceived as one's own, would allow accessing the motor system to the extent of promoting the functional recovery. In other words, the aim is to access the motor functioning through the (intact) somatosensory system, rather than through the (damaged) motor one. In addition, such a procedure provides the possibility to perform at least a part of the treatment remotely.
AIMS
The present research project on sport rehabilitation has the following goals:
- To validate a rehabilitation protocol in Immersive virtual reality (IVR) for restoring motor functions following peripheral injuries of the lower limbs. The protocol would be based on observation of actions rather than their execution. The rationale behind this idea is that indirect activation of the motor system through the observation of one's "own" virtual body that performs physical exercises would recruit the same neurocognitive mechanisms as those involved in the real motor control and action execution. This would improve the motor recovery by significantly enhancing the physical rehabilitation.
- To develop a standard protocol that would combine the neuroscientific approach based on IVR and the standards of sport rehabilitation and would create a new approach that would complement the classical rehabilitation and could be executed remotely at home.
SAMPLE Participants will be recruited at HastaFisio and Centro di Medicina Preventiva e dello Sport dell'Università degli Studi di Torino physiotherapy center s; the sample will consist of adults (age range 18-65 years) that underwent knee sprain and/or surgery to knee ligaments and/or meniscus after musculoskeletal injuries of the knee. The sample size was estimated based on a priori power analysis for mixed-effects 3x3 ANOVA with Time (Pre, Mid, and Post) as within-subject factor and Group (Experimental, Active control, No VR) as between-subject factor. To reach a power of 0.80 with a medium effect size (f = 0.25) and alpha level set at 0.05, the required sample size is 36 (12 participants per group). The study will recruit 45 participants (15 per group) to account for possible dropouts.
METHODS The first experimental session will take place within two weeks from the knee surgery and the IVR training intervention will last six weeks, in parallel with the first phase of standard physical rehabilitation. The IVR training protocol implies observing a virtual avatar in the first-person perspective (Experimental group), or in the third-person perspective (Active control group); another control group (No IVR training) will undergo only the standard physical training. In the virtual scenario, the avatar will perform a series of rehabilitation exercises (see details below). Before (T0), in the middle (T1) and after (T2) the intervention, the neuromuscular functions will be assessed with a battery of standard clinical tests (see details below). Moreover, in order to evaluate the efficacy of the IVR procedure, embodiment will be measured via an ad hoc questionnaire at the same time points.
Measures:
The following battery of tests will be collected at T0, T1 and T2:
- Before IVR training session:
- IKDC scale (International knee documentation committee subjective knee evaluation form);
- Joint position sense measured with GyKo (inertial measurement tool);
- Knee extension range of motion measured with GyKo (inertial measurement tool);
- Maximal force of the knee extensors measured via hand-held dynamometer;
- Visual analogue scale (VAS) for pain after maximal contraction.
- During the IVR training session:
- Embodiment questionnaire after the exercises are completed.
- After the IVR training session:
- Subjective familiarity with each exercise presented in the IVR training;
- General subjective feedback regarding the IVR session. Note that the clinical physiological measures (joint position sense, knee extension, maximal force of knee extensors) will be registered for both legs.
Training:
All groups of participants will follow two times per week the standard physical training protocol that will include exercises on strength, balance and flexibility. In addition, Experimental and Active control groups will participate in the IVR training administered on the same days as the physical training, always preceding it. The IVR training will be administered through a head-mounted display that allows presenting immersive 3D environments with a 360° field of view. The virtual scene will contain a gym with some standard equipment and a virtual avatar in natural size, gender-matched with the participants. The avatar will be seen either from the first-person perspective (i.e., as if the avatar replaced the real body; Experimental group), or from the third-person perspective (i.e., as if it was another person observed from the side; Active control group). After the initial familiarization and immersion phase, the avatar will perform a series of exercises (seated knee extension, squat, forward lunge, step up and down from a step, split squat, anterior reach of Y-balance test), 3 circuits with 8 repetition of each exercise, that imitate a real-life physical rehabilitation session. The avatar will perform the exercises on the injured-leg side (in cases when the exercises are one-legged).
Analysis:
The data obtained in the tests and questionnaires described above will be compared between the three groups (Experimental, Active control and No IVR training) and within the three time-points (T0, T1, T2) using a 3x3 mixed-effects ANOVA with Time as a within-subject factor and group as a between-subject factor. The hypothesis is that the Experimental group will show greater improvement in the injured limb's functional performance than the Active control group and No IVR training group.
IMPLICATIONS OF THE PROJECT From the theoretical perspective, the project will be the first to provide evidence of the fundamental role of the neurocognitive mechanisms underlying conscious representation of one's own body in motor rehabilitation of peripheral injuries. Indeed, at the present moment, only a few studies suggest that simply representing a body as one's own (without any need to perform movements) influences the motor system. Only one study examined whether this could have a positive influence on the motor functioning; however, those results were collected in patients with brain lesions, rather than peripheral ones. For these reasons, the project offers a new approach to rehabilitation that is based on hypothesis well-supported by the existing theoretical knowledge but remaining unexplored experimentally. Demonstrating that the illusion that one's own body was moving can promote the activation of brain areas involved in motor planning and execution (e.g., planning and execution of sport rehabilitation exercises), and therefore, improving the deficient motor functionality, would be a novel scientific finding. Moreover, demonstrating that the motor system can be affected through the signals related to the body via the properties of a virtual body, even in case of peripheral injuries, creates new opportunities in the more general context of motor rehabilitation.
In terms of impact on the rehabilitation science, the effects of the project outcomes will appear on several levels, since it proposes a radical change to the sport rehabilitation approach. The loss of motor functioning as a result of sport injuries is a debilitating event with a cascade of negative consequences. The state of the art of the rehabilitation includes standard protocols that are based on the execution of movements and that have to be performed in appropriately equipped structures (gyms of rehabilitation centers). Firstly, the IVR training does not require any physical movement execution, and therefore, can serve as a valuable addition to the standard rehabilitation protocols, or even replace some physical rehabilitation sessions. Secondly, IVR training can be performed remotely and autonomously by the patient, which is an important advantage for any type of intervention, especially in light of the current situation of the global pandemic. These two elements might greatly reduce the cumulative time and effort invested in the recovery from injuries. Thirdly, such approach is highly flexible by nature and can be complemented by other techniques and measures of motor behavior (e.g., movement kinematics, brain electrical activity, measures of the activity of the autonomic nervous system, etc.), depending on the specific needs and level of complexity.
- Conditions
- Knee Injuries
- Being tested
- VR_Training_1PP, VR_Training_3PP
- Keywords
- Knee reconstruction, Immersive virtual reality, Full body illusion, Motor rehabilitation
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR_Training_1PPCombination product
Immersive VR scenario of physical training with avatar embodiment
VR_Training_3PPCombination product
Immersive VR scenario of physical training without avatar embodiment
| Study group | Role | What they receive |
|---|---|---|
| VR_1PP | Experimental | Virtual training with an avatar observed from the first-person perspective Receives: Combination Product: VR_Training_1PP |
| VR_3PP | Active comparator | Virtual training with an avatar observed from the third-person perspective Receives: Combination Product: VR_Training_3PP |
| NO_VR | No intervention | No VR training administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: T2 (After 100% of VR training sessions, week 6)
Secondary outcomes (6)
Change of the knee extension measure from pre-training to post-training
Knee extension range of motion (degrees) measured with GyKo (inertial measurement tool)
Measured: 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
Maximal force of the knee extensors (N) measured via hand-held dynamometer
Measured: 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
Subjective scale (visual analogue scale) for pain after maximal contraction of the knee; min score = 0, max score = 10, where lower scores indicate lower level of pain
Measured: 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
Subjective familiarity with each exercise presented in the IVR training and general subjective feedback regarding the IVR session
Measured: T0 (Before VR training sessions)
Subjective feedback regarding the IVR experience mid-training
Subjective familiarity with each exercise presented in the IVR training and general subjective feedback regarding the IVR session
Measured: T1 (After 50% of VR training sessions, week 3)
Subjective feedback regarding the IVR experience post-training
Subjective familiarity with each exercise presented in the IVR training and general subjective feedback regarding the IVR session
Measured: T2 (After 100% of VR training sessions, week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start12 Apr 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- HastaFisio - Fisioterapia e Medicina dello Sport
- Responsible party
- Principal investigator, Lorenzo Pia, University of Turin, Italy
- Investigators
- Lorenzo Pia, PhD, Study chair, University of Turin, ItalyMaria Pyasik, PhD, Principal investigator, University of Turin, ItalyGennaro Boccia, PhD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364970
- Sponsor's protocol ID
- 1234
- Acronym
- IVR_MOT
- Status last verified
- May 2024
- First submitted
- 26 Apr 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be made publicly available in anonymized form via an online data repository (Mendeley data).
Publications
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.
PubMed 28577446Cumps 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.
PubMed 18048438Ekstrand 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.
PubMed 26746908Maselli 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.
PubMed 23519597Pyasik 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.
PubMed 30649514Pyasik 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.
PubMed 33434613Rossetti, 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.
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.
PubMed 33826456Whatman 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.
PubMed 22498149Winstein, 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.
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.
PubMed 31205423
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality in the Rehabilitation of Peripheral Injuries
- ClinicalTrials.gov ID
- NCT05364970
- Acronym / sponsor ID
- IVR_MOT / 1234
- Conditions
- Knee Injuries
- Keywords
- Knee reconstruction, Immersive virtual reality, Full body illusion, Motor rehabilitation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- HastaFisio - Fisioterapia e Medicina dello Sport
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND Sport injuries are an important obstacle both for sport performance and for maintaining a healthy lifestyle that implies continuous and regular physical activity. In Italy, each year there are approximately 300.000 admissions to the ER among 20 millions of people practicing sports.
As regards competitive sport, dense competition schedules, fast-paced rhythms and growing pressure experienced by athletes determine the increasing frequency of injuries. Injuries result in periods of refrain from competitions and affects athletes' psycho-physical balance. For these reasons, sport injuries have significant direct and indirect costs and physiotherapy aims to recover motor function to guarantee the fastest and safest return to sport.
Any form of motor rehabilitation, both in cases of damage to the central nervous system and those related to peripheral problems (as in the majority of sport injuries), is based on the concepts of plasticity and compensation. In other words, the possibility of recovery implies that the system can reorganize itself. In practical terms, rehabilitation science in its current form attempts to directly promote active and repetitive exercise of the damaged (motor) system. This logic, i.e., the process that is primarily based on action execution, has a major intrinsic limit that poses an obstacle for the treatment: it works directly with the motor functioning that is, however, compromised, even to a severe extent. However, it has been recently suggested that the motor system can be activated by simply observing one's own body perform the movements, without any actual movement execution. In line with that, and taking advantage of the multisensory nature and the sense of presence and embodiment that Immersive virtual reality (IVR) provides, it has been shown that it is possible to create an illusory experience that a moving virtual body (avatar) temporarily became one's own moving body (so-called embodiment. Moreover, this experience activates the motor system in a way similar to the activation from one's own actual movements. Therefore, in such conditions, the (illusory) movements of the embodied virtual body are integrated in the participant's motor system.
Based on these theoretical considerations, the present project proposes to employ the IVR to test a possible drastic change to the rehabilitation approach that would bypass/limit the problem of the (deficient) motor execution. The main hypothesis is that simple observation of a moving virtual body, which is perceived as one's own, would allow accessing the motor system to the extent of promoting the functional recovery. In other words, the aim is to access the motor functioning through the (intact) somatosensory system, rather than through the (damaged) motor one. In addition, such a procedure provides the possibility to perform at least a part of the treatment remotely.
AIMS
The present research project on sport rehabilitation has the following goals:
- To validate a rehabilitation protocol in Immersive virtual reality (IVR) for restoring motor functions following peripheral injuries of the lower limbs. The protocol would be based on observation of actions rather than their execution. The rationale behind this idea is that indirect activation of the motor system through the observation of one's "own" virtual body that performs physical exercises would recruit the same neurocognitive mechanisms as those involved in the real motor control and action execution. This would improve the motor recovery by significantly enhancing the physical rehabilitation.
- To develop a standard protocol that would combine the neuroscientific approach based on IVR and the standards of sport rehabilitation and would create a new approach that would complement the classical rehabilitation and could be executed remotely at home.
SAMPLE Participants will be recruited at HastaFisio and Centro di Medicina Preventiva e dello Sport dell'Università degli Studi di Torino physiotherapy center s; the sample will consist of adults (age range 18-65 years) that underwent knee sprain and/or surgery to knee ligaments and/or meniscus after musculoskeletal injuries of the knee. The sample size was estimated based on a priori power analysis for mixed-effects 3x3 ANOVA with Time (Pre, Mid, and Post) as within-subject factor and Group (Experimental, Active control, No VR) as between-subject factor. To reach a power of 0.80 with a medium effect size (f = 0.25) and alpha level set at 0.05, the required sample size is 36 (12 participants per group). The study will recruit 45 participants (15 per group) to account for possible dropouts.
METHODS The first experimental session will take place within two weeks from the knee surgery and the IVR training intervention will last six weeks, in parallel with the first phase of standard physical rehabilitation. The IVR training protocol implies observing a virtual avatar in the first-person perspective (Experimental group), or in the third-person perspective (Active control group); another control group (No IVR training) will undergo only the standard physical training. In the virtual scenario, the avatar will perform a series of rehabilitation exercises (see details below). Before (T0), in the middle (T1) and after (T2) the intervention, the neuromuscular functions will be assessed with a battery of standard clinical tests (see details below). Moreover, in order to evaluate the efficacy of the IVR procedure, embodiment will be measured via an ad hoc questionnaire at the same time points.
Measures:
The following battery of tests will be collected at T0, T1 and T2:
- Before IVR training session:
- IKDC scale (International knee documentation committee subjective knee evaluation form);
- Joint position sense measured with GyKo (inertial measurement tool);
- Knee extension range of motion measured with GyKo (inertial measurement tool);
- Maximal force of the knee extensors measured via hand-held dynamometer;
- Visual analogue scale (VAS) for pain after maximal contraction.
- During the IVR training session:
- Embodiment questionnaire after the exercises are completed.
- After the IVR training session:
- Subjective familiarity with each exercise presented in the IVR training;
- General subjective feedback regarding the IVR session. Note that the clinical physiological measures (joint position sense, knee extension, maximal force of knee extensors) will be registered for both legs.
Training:
All groups of participants will follow two times per week the standard physical training protocol that will include exercises on strength, balance and flexibility. In addition, Experimental and Active control groups will participate in the IVR training administered on the same days as the physical training, always preceding it. The IVR training will be administered through a head-mounted display that allows presenting immersive 3D environments with a 360° field of view. The virtual scene will contain a gym with some standard equipment and a virtual avatar in natural size, gender-matched with the participants. The avatar will be seen either from the first-person perspective (i.e., as if the avatar replaced the real body; Experimental group), or from the third-person perspective (i.e., as if it was another person observed from the side; Active control group). After the initial familiarization and immersion phase, the avatar will perform a series of exercises (seated knee extension, squat, forward lunge, step up and down from a step, split squat, anterior reach of Y-balance test), 3 circuits with 8 repetition of each exercise, that imitate a real-life physical rehabilitation session. The avatar will perform the exercises on the injured-leg side (in cases when the exercises are one-legged).
Analysis:
The data obtained in the tests and questionnaires described above will be compared between the three groups (Experimental, Active control and No IVR training) and within the three time-points (T0, T1, T2) using a 3x3 mixed-effects ANOVA with Time as a within-subject factor and group as a between-subject factor. The hypothesis is that the Experimental group will show greater improvement in the injured limb's functional performance than the Active control group and No IVR training group.
IMPLICATIONS OF THE PROJECT From the theoretical perspective, the project will be the first to provide evidence of the fundamental role of the neurocognitive mechanisms underlying conscious representation of one's own body in motor rehabilitation of peripheral injuries. Indeed, at the present moment, only a few studies suggest that simply representing a body as one's own (without any need to perform movements) influences the motor system. Only one study examined whether this could have a positive influence on the motor functioning; however, those results were collected in patients with brain lesions, rather than peripheral ones. For these reasons, the project offers a new approach to rehabilitation that is based on hypothesis well-supported by the existing theoretical knowledge but remaining unexplored experimentally. Demonstrating that the illusion that one's own body was moving can promote the activation of brain areas involved in motor planning and execution (e.g., planning and execution of sport rehabilitation exercises), and therefore, improving the deficient motor functionality, would be a novel scientific finding. Moreover, demonstrating that the motor system can be affected through the signals related to the body via the properties of a virtual body, even in case of peripheral injuries, creates new opportunities in the more general context of motor rehabilitation.
In terms of impact on the rehabilitation science, the effects of the project outcomes will appear on several levels, since it proposes a radical change to the sport rehabilitation approach. The loss of motor functioning as a result of sport injuries is a debilitating event with a cascade of negative consequences. The state of the art of the rehabilitation includes standard protocols that are based on the execution of movements and that have to be performed in appropriately equipped structures (gyms of rehabilitation centers). Firstly, the IVR training does not require any physical movement execution, and therefore, can serve as a valuable addition to the standard rehabilitation protocols, or even replace some physical rehabilitation sessions. Secondly, IVR training can be performed remotely and autonomously by the patient, which is an important advantage for any type of intervention, especially in light of the current situation of the global pandemic. These two elements might greatly reduce the cumulative time and effort invested in the recovery from injuries. Thirdly, such approach is highly flexible by nature and can be complemented by other techniques and measures of motor behavior (e.g., movement kinematics, brain electrical activity, measures of the activity of the autonomic nervous system, etc.), depending on the specific needs and level of complexity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR_1PP | Experimental | Combination Product: VR_Training_1PPVirtual training with an avatar observed from the first-person perspective |
| VR_3PP | Active comparator | Combination Product: VR_Training_3PPVirtual training with an avatar observed from the third-person perspective |
| NO_VR | No intervention | –No VR training administered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- History of neurological or psychiatric disorders
- Motion sickness during IVR use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR_Training_1PPImmersive VR scenario of physical training with avatar embodiment | Combination product | VR_1PP |
| VR_Training_3PPImmersive VR scenario of physical training without avatar embodiment | Combination product | VR_3PP |
Primary outcome
Change of the IKDC scale score from pre-training to post-training
Time frame: T0 (Before VR training sessions), T1 (After 50% of VR training sessions, week 3), T2 (After 100% of VR training sessions, week 6)
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).
Change of the joint position sense measure from pre-training to post-training
Time frame: T0 (Before VR training sessions), T1 (After 50% of VR training sessions, week 3), T2 (After 100% of VR training sessions, week 6)
Joint position sense measured with GyKo (inertial measurement tool)
Embodiment questionnaire pre-training
Time frame: T0 (Before VR training sessions)
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
Embodiment questionnaire mid-training
Time frame: T1 (After 50% of VR training sessions, week 3)
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
Embodiment questionnaire post-training
Time frame: T2 (After 100% of VR training sessions, week 6)
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
6 secondary outcomes
Change of the knee extension measure from pre-training to post-training
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: T0 (Before VR training sessions)
Subjective feedback regarding the IVR experience mid-training
Time frame: T1 (After 50% of VR training sessions, week 3)
Subjective feedback regarding the IVR experience post-training
Time frame: T2 (After 100% of VR training sessions, week 6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Results publication: PubMed 28577446Burin 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.
- Results publication: PubMed 18048438Cumps 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.
- Results publication: PubMed 26746908Ekstrand 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.
- Results publication: PubMed 23519597Maselli 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.
- Results publication: PubMed 30649514Pyasik 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.
- Results publication: PubMed 33434613Pyasik 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.
- Results publicationRossetti, 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.
- Results publication: PubMed 33826456Tambone 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.
- Results publication: PubMed 22498149Whatman 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.
- Results publicationWinstein, 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.
- Results publication: PubMed 31205423Pyasik 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.
- Individual participant dataSharing planned: Yes. Individual participant data will be made publicly available in anonymized form via an online data repository (Mendeley data).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Pia, PhD study chair
University of Turin, Italy
Maria Pyasik, PhD principal investigator
University of Turin, Italy
Gennaro Boccia, PhD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing VR_Training_1PP and VR_Training_3PP in people with Knee Injuries, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Pia, PhD (011 6703922 ext. +39, lorenzo.pia@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the IKDC scale score from pre-training to post-training (time frame: T0 (Before VR training sessions), T1 (After 50% of VR training sessions, week 3), T2 (After 100% of VR training sessions, week 6)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05364970, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.