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

Not Applicable

Completed

• Conditions: Phantom Limb Pain

• Registration Number: NCT03112928
• Lead Sponsor: Integrum

Brief 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).

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-13
• Study Start: 2017-05-08
• Status Verified: 2020-09
• Primary Completion: 2021-03-12
• Study Completion: 2021-09-20
• Last Update Submitted: 2023-06-17
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Rating Index registered at the beginning (1st session) and at the end of the treatment (15th session).	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.

Secondary Outcome Measures

Name	Time	Method
Pain Disability Index registered at the beginning (1st session) and the end of the treatment (15th session).	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.

Trial Locations

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; 🇸🇪 Göteborg, Västergötland, Sweden