Mixed Reality Based System to Manage Phantom Pain Phantom Pain for Patients With Lower Limb Amputation (MrMAPP)
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|ClinicalTrials.gov Identifier: NCT04529083|
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Phantom Limb Pain||Device: Mr. MAPP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pilot study to evaluate feasibility|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Functional Outcomes of a Novel Mixed Reality Based System to Manage Phantom Pain for Patients With Lower Limb Amputation.|
|Actual Study Start Date :||May 21, 2018|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Mixed Reality System for virtual mirror therapy
Device: Mr. MAPP
Mixed reality device to provide virtual mirror therapy to patients with phantom pain
- Change in Numerical Rating Scale [ Time Frame: baseline, 1-month ]Pain intensity; 0-10; higher is worse
- Change in McGill Pain Questionnaire [ Time Frame: baseline, 1-month ]Pain intensity and interference; multiple scales; higher is worse
- Change in Patient Specific Functional Questionnaire [ Time Frame: baseline, 1-month ]Patient specific functional questionnaire; multiple scales; higher is better
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529083
|Contact: Thiru M Annaswamy, MDemail@example.com|
|Contact: Gargi Raval, MDfirstname.lastname@example.org|
|United States, Texas|
|VA North Texas Health Care System||Recruiting|
|Dallas, Texas, United States, 75216|
|Principal Investigator: Thiru Annaswamy, MD|
|Principal Investigator: Gargi Raval, MD|
|Principal Investigator:||Gargi Raval, MD||North Texas Veterans Healthcare System|