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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
77
Neuromotus - PME decodes motor volition applying machine learning to surface electromyography. Once the intention of movement is known, this is use to control serious games in virtual and augmented reality. A treatment session of MPE consists of: 1. Pain evaluation 2. Placement of the electrodes and fiducial marker 3. Practice of motor execution in Augmented Reality (AR) 4. Gaming using phantom movements 5. Practice of motor execution by matching random target postures of a virtual limb. Step 3 to 4 are repeated for different phantom joints, initially one at the time progressing to several joints simultaneously. A treatment session last 2 hours.
The only difference between PME and PMI is that in the former myoelectric signals are used to give the participants control over the virtual environments, whereas in PMI the presence of myoelectric activity is used as an alarm to remind the participant that it must imagine rather than execute the phantom movement. In PMI the virtual environments act autonomously to guide the participant in imagination of movement.
Shirley Ryan Ability Lab
Chicago, Illinois, United States
Institue of Biomedical Engineering, University of New Brunswick
Fredericton, New Brunswick, Canada
Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr - University Bochum (RUB)
Bochum, Germany
Pain Rating Index registered at the beginning (1st session) and at the end of the treatment (15th session).
The Pain Rating Index (PRI) is calculated as the sum of 15 descriptors. At the end of each treatment session the descriptors are presented to the patient, who rates each of them with an intensity scale from 0 to 3. The PRI is therefore a number between 0 and 45: the higher the index the greater is the pain. The primary efficacy variable for this study is the change in PRI between the first and the last treatment session.
Time frame: 28-40 weeks, depending on the frequency of the sessions.
Pain Disability Index registered at the beginning (1st session) and the end of the treatment (15th session).
The Pain Disability Index (PDI) measures the impact that pain has on the ability of a person to participate in essential life activities. The index is comprised between 0 and 70. The higher the index the greater the person's disability due to pain is. The secondary efficacy variable of this study is the change in PDI between the first and the last treatment session.
Time frame: 28-40 weeks, depending on the frequency of the sessions.
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School of Psychology, National University of Ireland
Galway, Connacht, Ireland
University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine
Groningen, Netherlands
University Rehabilitation Institute
Ljubljana, Slovenia
Ortopedteknik, Region Örebro län
Örebro, Närke, Sweden
Bräcke Diakoni
Stockholm, Uppland, Sweden
Gåskolan, Ortopedtekniska avdelningen
Gothenburg, Västergötland, Sweden