Mixed Reality Based System to Manage Phantom Pain Phantom Pain for Patients With Lower Limb Amput… (NCT04529083) | Clinical Trial Compass
CompletedNot Applicable
Mixed Reality Based System to Manage Phantom Pain Phantom Pain for Patients With Lower Limb Amputation
United States11 participantsStarted 2018-05-21
Plain-language 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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women, over the age of 18 with lower limb amputations (greater than 3 months post surgery) with phantom limb pain
Exclusion Criteria:
* Patients with lower limb amputations with open wounds or active infection in residual or contralateral limbs.
* Patients with history of seizures.
* Patients with visual (self-reported) or cognitive impairment (assessed by the mini-mental state examination) that interferes with ability to interact with, participate in, and adhere to a computerized rehabilitation system.
* Any patient with a cardiac event in the last 6 months.
* Any patient with an active medical issue to minimize risk of exacerbating their condition.
* Lives more than 60 miles away from the Dallas VA Medical Center
* Any patient with the motion sickness induced by head mounted displays (HMDs) or immersive environment.
* Any patient experiencing the motion sickness induced by HMDs during the therapy session can also opt out of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.