Phantom Motor Execution Via MPR, VR/AR, and SG, as a Treatment of PLP
NCT ID: NCT03112928
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2017-05-08
2021-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Study Groups
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Phantom Motor Execution (PME)
Phantom motor execution is decoded via myoelectric pattern recognition and promoted via serious gaming in virtual and augmented reality.
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:
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.
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.
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.
Interventions
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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:
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.
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 Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* The subject should not have any condition associated with risk of poor protocol compliance.
* The subject should not have any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgement.
18 Years
ALL
No
Sponsors
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Chalmers University of Technology
OTHER
Sahlgrenska University Hospital
OTHER
Örebro University, Sweden
OTHER
Bräcke Diakoni, Sweden
UNKNOWN
University Rehabilitation Institute, Republic of Slovenia
OTHER
University Medical Center Groningen
OTHER
University of New Brunswick
OTHER
National University of Ireland, Galway, Ireland
OTHER
Shirley Ryan AbilityLab
OTHER
Ruhr University of Bochum
OTHER
Integrum
INDUSTRY
Responsible Party
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Principal Investigators
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Max Ortiz Catalan, PhD
Role: PRINCIPAL_INVESTIGATOR
Chalmers Technological University
Locations
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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
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
Countries
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References
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Ortiz-Catalan M, Guethmundsdottir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragno C, Pihlar Z, Burger H, Hermansson L. Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain. Lancet. 2016 Dec 10;388(10062):2885-2894. doi: 10.1016/S0140-6736(16)31598-7. Epub 2016 Dec 2.
Ortiz-Catalan M, Sander N, Kristoffersen MB, Hakansson B, Branemark R. Treatment of phantom limb pain (PLP) based on augmented reality and gaming controlled by myoelectric pattern recognition: a case study of a chronic PLP patient. Front Neurosci. 2014 Feb 25;8:24. doi: 10.3389/fnins.2014.00024. eCollection 2014.
Lendaro E, Van der Sluis CK, Hermansson L, Bunketorp-Kall L, Burger H, Keesom E, Widehammar C, Munoz-Novoa M, McGuire BE, O'Reilly P, Earley EJ, Iqbal S, Kristoffersen MB, Stockselius A, Gudmundson L, Hill W, Diers M, Turner KL, Weiss T, Ortiz-Catalan M. Extended reality used in the treatment of phantom limb pain: a multicenter, double-blind, randomized controlled trial. Pain. 2025 Mar 1;166(3):571-586. doi: 10.1097/j.pain.0000000000003384. Epub 2024 Sep 5.
Lendaro E, Earley EJ, Ortiz-Catalan M. Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain. Trials. 2022 Feb 13;23(1):138. doi: 10.1186/s13063-021-05962-7.
Lendaro E, Hermansson L, Burger H, Van der Sluis CK, McGuire BE, Pilch M, Bunketorp-Kall L, Kulbacka-Ortiz K, Rigner I, Stockselius A, Gudmundson L, Widehammar C, Hill W, Geers S, Ortiz-Catalan M. Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial. BMJ Open. 2018 Jul 16;8(7):e021039. doi: 10.1136/bmjopen-2017-021039.
Other Identifiers
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007733
Identifier Type: -
Identifier Source: org_study_id
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