Phantom Limb Pain Clinical Trial
Official title:
Phantom Motor Execution Via Myoelectric Pattern Recognition, Virtual and Augmented Reality, and Serious Gaming as a Treatment of Phantom Limb Pain
This international, multi-center, double-blind, randomized, controlled clinical trial aims to evaluate the efficacy of Phantom Motor Execution (PME) and Phantom Motor Imagery (PMI) as treatments of Phantom Limb Pain (PLP). In PME, myoelectric pattern recognition (MPR) is used to predict motor volition and then use the decoded movements to control virtual and augmented reality environments (VR/AR), along with serious gaming (SG). The same device and VR/AR environments are used in PMI with the difference that subjects will imagine rather than execute phantom movements. Electromyography is used to monitor for no muscular activity in PMI.
Sixty-six subjects with upper or lower limb amputations are planned to take part in this study. Subjects will be assigned randomly to PME and PMI treatments (2:1 proportion). After treatment completion (15 sessions of 2 hours each) and follow-up period of six months, patients that received PMI will be given the choice to receive PME. The design is double blinded as the patient will be informed that the treatment received, regardless of which, has been shown effective in previous studies. The person conducting the pain evaluations will be blinded to which treatment each patient receives, and will not take part on providing treatment (evaluator and therapist are different persons). ;
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