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IVR in Motor Rehabilitation - Trial NCT05364970

Access comprehensive clinical trial information for NCT05364970 through Pure Global AI's free database. This Phase 1 trial is sponsored by University of Turin, Italy and is currently Not yet recruiting. The study focuses on Knee Injuries. Target enrollment is 45 participants.

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NCT05364970
Phase 1
Not yet recruiting
combination product
Trial Details
ClinicalTrials.gov โ€ข NCT05364970
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IVR in Motor Rehabilitation
Immersive Virtual Reality in the Rehabilitation of Peripheral Injuries

Study Focus

Knee Injuries

VR_Training_1PP

Interventional

combination product

Sponsor & Location

University of Turin, Italy

Timeline & Enrollment

Phase 1

Jun 01, 2022

Jun 01, 2025

45 participants

Primary Outcome

Change of the IKDC scale score from pre-training to post-training,Change of the joint position sense measure from pre-training to post-training,Embodiment questionnaire pre-training,Embodiment questionnaire mid-training,Embodiment questionnaire post-training

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.

ICD-10 Classifications

Injuries to the knee and lower leg
Sprain and strain of other and unspecified parts of knee
Other spontaneous disruption of ligament(s) of knee
Crushing injury of knee
Injury to multiple structures of knee

Data Source

ClinicalTrials.gov

NCT05364970

Non-Device Trial