Abstract
Objective This report describes the details of Mr. MAPP, a virtual mirror therapy system and the results of a clinical feasibility and evaluation study of a pilot sample of patients with history of lower limb amputation and phantom limb pain.
Materials and Methods Mr. MAPP system uses a Kinect V2 RGB-D camera to capture the patient, generates a live interactive 3D model, and incorporates it into a virtual exergame. Mr. MAPP mirrors their preserved limb and allows participants to visualize their amputated limb virtually and perform their prescribed exercise program. Mr. MAPP creates a digital diary of their therapy sessions by recording game performance and errors. Ten consecutive patients with history of limb loss and phantom pain were targeted for this pilot study. They received a Mr. MAPP system and a laptop for home use for 1-month. Outcome measures including pain intensity and pain interference measured on Numerical Rating Scale (NRS) and McGill Pain Questionnaire (MPQ) as well as functional outcomes measured on Patient Specific Functional Scale (PSFS) were obtained at baseline, and after 1-month.
Results Seven participants were enrolled, out of which four completed the study. The study was temporarily suspended due to restrictions imposed during the COVID-19 public health emergency. In-game performance data showed a trend towards improvement in most participants. Compared to baseline, NRS and MPQ scores at 1-month showed no clear trends. PSFS scores improved for 1 participant and remained unchanged for others.
Conclusion Gamified home exercises performed via a novel, mixed-reality system—Mr. MAPP— using which virtual mirror therapy was delivered, is feasible and has potential to improve pain and pain related function in patients with lower limb amputations and phantom limb pain.
Competing Interest Statement
The authors have declared no competing interest.
Clinical Trial
ClinicalTrials.gov Identifier: NCT04529083 (Retrospectively registered) Explanation for why the trial was retrospectively registered: Initial guidance we received was that pilot clinical studies are not considered clinical trials and do not need to be registered as such.
Funding Statement
No external funding was received for the conduct of this study. One or more authors of this work are/were employed by the US federal government and this work was conducted while they were working for the US federal government.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Institutional Review Board of VA North Texas Health Care System approved this study
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
Data Availability
All data referred to in this manuscript is available and stored in the institutional's data repository.