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Phantom Motor Execution Via MPR, VR/AR, and SG, as a Treatment of PLP | Clinical Trials | Clareo Health

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Phantom Motor Execution Via MPR, VR/AR, and SG, as a Treatment of PLP

Phantom Motor Execution Via Myoelectric Pattern Recognition, Virtual and Augmented Reality, and Serious Gaming as a Treatment of Phantom Limb Pain

NCT03112928•Integrum

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject must be older than 18 years.
•If the subjects are under pharmacological treatments, there must be no variations on the medicament dosages for at least one month (steady consumption).
•The last session of previous treatments must be at least 3 months old.
•Any pain reduction potentially attributed to previous phantom limb pain treatments must be at least 3 months old.
•Subjects must have control over at least a portion of biceps and triceps muscles for upper limb amputations, and quadriceps and hamstrings for the lower limb amputations.
•The subject has signed a written informed consent.
•The subject must be in a stable prosthetic situation (i.e. satisfied with the fitting of the prosthesis) or being a non user.
•At least six months should be passed since the amputation: acute phantom limb pain cases should not be included in the study.
•The patient subject should not have a significant cognitive impairment that prevents the patient from following instructions.
•Subjects with abundant soft tissue on their stump will not be automatically excluded, however, an evaluation in the system is required to analyze if sufficient electromyography signals can be recorded.

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.

Locations (9)

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

Key Dates

Start Date

May 8, 2017

Primary Completion Date

March 12, 2021

Completion Date

September 20, 2021

Last Updated

June 22, 2023

Enrollment

ACTUAL participants

Conditions

Phantom Limb Pain

Interventions

Phantom Motor Execution

DEVICE

Phantom Motor Imagery

DEVICE

Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees

NCT07420192

Symptomatic NeuromaPhantom Limb Pain After Amputation+3 more

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RECRUITINGNA

Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System

NCT07324109

Phantom Limb Pain After AmputationLower Limb Amputation Above Knee+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phantom Motor Execution Via MPR, VR/AR, and SG, as a Treatment of PLP

Inclusion Criteria

Exclusion Criteria

Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees

Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System

Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response

TITAN Trial: Reducing Phantom Limb Pain in People with Amputations

Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life

Kinematics-Based Prediction of Chronic Pain After Combat-Related Extremity Trauma