An observational study in Phantom Limb Pain, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by University of Manitoba · Observational
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.
Participants will:
There are many barriers that prevent people with lower limb amputations (LLA) from receiving effective nonpharmacological treatment for their phantom limb pain (PLP), such as long outpatient wait times and the sparse number of amputation rehabilitation specialists. Early administration of effective PLP treatments, such as graded motor imagery (GMI), may improve both treatment access and efficacy if it is administered through virtual reality (VR). However, no VR GMI treatments have been developed or tested in the acute postoperative period following LLA to prevent PLP. The current study will recruit 30 patients being treated for LLA at the Health Sciences Centre (HSC) in Winnipeg, Manitoba to assess the feasibility and pilot outcomes of a novel VR GMI program administered in the postoperative acute care setting, with the goal of preventing and or reducing PLP. First, the researchers predict the mean acceptability, tolerability, and length of engagement in the VR program will be high across administration contexts and each of the VR stages. Second, the researchers hypothesize the recruitment strategies employed will capture and retain a large, representative sample of individuals undergoing LLA at the HSC. Lastly, the researchers predict length of VR program engagement will demonstrate a preliminary effect on PLP incidence, intensity, and interference at one-month follow-up. Baseline characteristics such as anxiety, depression, and amputation etiology will also be explored as extraneous variables. This research will be the first to provide evidence for the feasibility of VR PLP treatment administered immediately following LLA. The results will inform future development of the VR program and optimize the study procedures for an upcoming randomized clinical trial.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's enrollment of 20 is below the median of 67 across 25 observational studies indexed under Phantom Limb.
Browse Phantom Limb studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Participants will be recruited from population of individuals undergoing lower limb amputation at the Health Sciences Center (a public inpatient tertiary care hospital) in Winnipeg, Manitoba.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
These participants will receive the virtual reality intervention for at least 20 minutes daily for approximately seventeen sessions, or as long as they are able.
Device: Virtual Reality
The virtual reality (VR) intervention administers graded motor imagery (GMI) treatment for phantom limb pain. It consists of three stages: left right sorting task (a sorting task where participants sort images of left and right feet), explicit motor imagery (a series of guided imagery exercises administered via audio to facilitate focus on the phantom limb), and the limb simulation task (where participants perform a series of exercises with virtual legs to create the illusion of movement in their phantom limb). The limb simulation stage can also be conducted with leg trackers to generate a higher degree of illusion in the virtual legs.
Acceptability
The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items.
Time frame: Immediately after intervention is administered
Tolerability of the virtual reality simulation
Numerical Rating Scale for phantom limb pain, residual limb pain (i.e., physical pain at the amputation site), nausea (NRS \> 2 on any construct indicates an adverse event and lack of tolerability). Range 0-10 on each NRS.
Time frame: Immediately before and after intervention administration
Engagement
Length of time in minutes spent in the virtual reality program per session (recommended: 20 minutes)
Time frame: During intervention administration, up to seventeen days
Phantom Limb Pain Intensity
Brief Pain Inventory (Pain Intensity Only). Range 0-40, higher scores = higher pain intensity.
Time frame: One month follow-up
Phantom Limb Pain Interference
Patient-Reported Outcome Measurement System Pain Interference Scale-- 8a. Range 8-40, higher score = higher pain interference.
Time frame: One month follow-up
Embodiment
Virtual Embodiment Questionnaire. Range 1-7 for 12 items, higher score = higher embodiment.
Time frame: Administered after intervention administration is completed, up to seventeen days
Presence
iGroup Presence Questionnaire. Range -3 to +3 for each of 14 items, higher score = higher presence.
Time frame: Administered after intervention administration is completed, up to seventeen days
Anxiety
Generalized Anxiety Disorder 7. Range 0 to 21, higher score = higher anxiety.
Time frame: Baseline
Depression
Patient Health Questionnaire 9. Range 0 to 27, higher score = higher depressive symptoms.
Time frame: Baseline
Plan to share: No — It is not typical to share the individual participant data from a feasibility study.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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