CompletedNot Applicable

Assessing the Feasibility of a Virtual Reality Intervention for Phantom Pain Immediately Following Lower Limb Amputation

Canada20 participantsStarted 2024-07-26

Plain-language summary

The goal of this observational study is to see whether a new virtual reality (VR) program meant to treat phantom limb pain (PLP) is feasible to people immediately following lower limb amputation. This study aims to answer three questions. 1. Is this VR treatment acceptable to people immediately following lower limb amputation? 2. Are the researchers able to recruit participants that represent the population in need of this treatment, and will these participants stay until the end of the study? 3. Do participants who use the VR program more have less severe PLP than participants who use the VR program for fewer sessions? Participants will: * Try the VR program in the hospital, their home, and in physiotherapist clinics daily for about seventeen sessions. * After each session, participants will fill out questionnaires asking about their level of pain, their nausea, and how acceptable they find the program. They will also complete measures asking about how they're feeling and what led to their amputation. * One month following their final VR session, researchers will phone the participants to ask them to rate how severe their PLP is.

Who can participate

Age range

18 Years – 80 Years

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: * if they underwent or are about to undergo an LLA (hip, below-knee, above-knee, or foot) within the last two months * if they are currently receiving inpatient treatment at the Health Sciences Centre (HSC) in Winnipeg, Canada * if they can speak/read English fluently Exclusion Criteria: * any visual, hearing, or motor impairment that would affect engaging with a head-mounted VR headset or hand controls, as interpreted by the research team or nursing staff

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.

What they're measuring

Acceptability

Timeframe: Immediately after intervention is administered

Tolerability of the virtual reality simulation

Timeframe: Immediately before and after intervention administration

Engagement

Timeframe: During intervention administration, up to seventeen days

Trial details

NCT IDNCT06638918

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-17

View on ClinicalTrials.gov More Phantom Limb Pain trials