Phantom Motor Execution Via MPR, VR/AR, and SG, as a Treatment of PLP
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03112928|
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : March 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Phantom Limb Pain||Device: Phantom Motor Execution Device: Phantom Motor Imagery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||International, multi-centre, double-blind, randomized, controlled clinical trial|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
Participants will be informed that both treatments have been shown effective in previous studies, and in the present study we are comparing their efficacy.
The person conducting the pain evaluation (outcomes assessor) will not treat the participants and will be unaware of which treatment is given to each participant. The person treating the subject is different than the person evaluating.
The principal and coordinating investigator will receive blinded data from all participating centers to analyze the clinical trial outcomes.
|Official Title:||Phantom Motor Execution Via Myoelectric Pattern Recognition, Virtual and Augmented Reality, and Serious Gaming as a Treatment of Phantom Limb Pain|
|Actual Study Start Date :||May 8, 2017|
|Actual Primary Completion Date :||March 12, 2021|
|Actual Study Completion Date :||September 20, 2021|
Experimental: Phantom Motor Execution (PME)
Phantom motor execution is decoded via myoelectric pattern recognition and promoted via serious gaming in virtual and augmented reality.
Device: Phantom Motor Execution
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:
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.
Other Name: Neuromotus - PME
Active Comparator: Phantom Motor Imagery (PMI)
Use the same device and visual stimulation as PME, with the difference that participants imagine to perform, rather than execute phantom movements. Myoelectric activity is used to monitor that the subjects do not produce muscular contractions but only imagine the movements.
Device: Phantom Motor Imagery
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.
Other Name: Neuromotus - PMI
- Pain Rating Index registered at the beginning (1st session) and at the end of the treatment (15th session). [ Time Frame: 28-40 weeks, depending on the frequency of the sessions. ]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.
- Pain Disability Index registered at the beginning (1st session) and the end of the treatment (15th session). [ Time Frame: 28-40 weeks, depending on the frequency of the sessions. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112928
|United States, Illinois|
|Shirley Ryan Ability Lab|
|Chicago, Illinois, United States, 60611|
|Canada, New Brunswick|
|Institue of Biomedical Engineering, University of New Brunswick|
|Fredericton, New Brunswick, Canada, E3B 5A3|
|School of Psychology, National University of Ireland|
|Galway, Connacht, Ireland|
|University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine|
|Groningen, Netherlands, 9700 RB|
|University Rehabilitation Institute|
|Ljubljana, Slovenia, 1000|
|Ortopedteknik, Region Örebro län|
|Örebro, Närke, Sweden, 701 16|
|Stockholm, Uppland, Sweden, 17078|
|Gåskolan, Ortopedtekniska avdelningen|
|Göteborg, Västergötland, Sweden, 41285|
|Principal Investigator:||Max Ortiz Catalan, PhD||Chalmers Technological University|