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临床试验/NCT05364970
NCT05364970招募中早期 1 期

Immersive Virtual Reality in the Rehabilitation of Peripheral Injuries

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年4月12日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
招募中
发起方
入组人数
45
试验地点
2
主要终点
Change of the joint position sense measure from pre-training to post-training

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 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)

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

时间窗: 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).

Embodiment questionnaire pre-training

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • Subjective feedback regarding the IVR experience mid-training(T1 (After 50% of VR training sessions, week 3))
  • 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))
  • Subjective feedback regarding the IVR experience post-training(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))

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lorenzo Pia

Associate Professor

University of Turin, Italy

研究点 (2)

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