CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Mr. MAPPdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04529083
NCT04529083N/ACompleted

Feasibility and Functional Outcomes of a Novel Mixed Reality Based System to Manage Phantom Pain for Patients With Lower Limb Amputation.

Dallas VA Medical Center·interventional·Posted Aug 27, 2020·Updated Jul 3, 2024

In Brief

A clinical study evaluating Mr. MAPP for Phantom Limb Pain. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The primary goals of this pilot research project are a) to design and develop the a mixed reality based system for managing phantom pain and b) to evaluate the feasibility and preliminary functional outcomes of this system in a sample of patients with lower limb amputation. Findings from this pilot study will serve as preliminary data to inform regarding a fully powered clinical trial to determine the effectiveness and practical implementation of these findings in real-world settings. Aim1: Design and develop a feasible mixed reality based system to manage phantom pain in patients with lower limb amputation qualifying for on-going mirror therapy. Hypothesis 1: The investigators hypothesize that the mixed reality based system to manage phantom pain will be feasible and well-received by a sample of patients with lower limb amputation needing mirror therapy. Aim2: Evaluate functional outcomes in a sample of lower limb amputees (n=10), using this mixed reality based system to manage phantom pain. Hypothesis 2: Using this system, the investigators hypothesize that patients who participate in the mixed reality based system will show improvements in functional mobility based on performance evaluations and patient reported outcome measures (PROs). The investigators also hypothesize that this mixed reality based system will help to alleviate the phantom pain based on McGill Pain questionnaire and visual analog scale (VAS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 27, 2020
Enrollment StartMay 21, 2018
Primary CompletionJul 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 5.8 years ago

Interventions

Mr. MAPPdevice

Mixed reality device to provide virtual mirror therapy to patients with phantom pain