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| Name | Class |
|---|---|
| Health Sciences Centre, Winnipeg, Manitoba | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Group | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | The Theoretical Framework of Acceptability Questionnaire (TFAQ score > 3 indicates acceptability). Range 1-5 on seven items. | 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. | Immediately before and after intervention administration |
| Engagement | Length of time in minutes spent in the virtual reality program per session (recommended: 20 minutes) | During intervention administration, up to seventeen days |
| Measure | Description | Time Frame |
|---|---|---|
| Phantom Limb Pain Intensity | Brief Pain Inventory (Pain Intensity Only). Range 0-40, higher scores = higher pain intensity. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Generalized Anxiety Disorder 7. Range 0 to 21, higher score = higher anxiety. | Baseline |
| Depression | Patient Health Questionnaire 9. Range 0 to 27, higher score = higher depressive symptoms. |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Renee El-Gabalawy, PhD | Associate Professor and Clinical Psychologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Center | Winnipeg | Manitoba | R3E 0Z2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40409745 | Derived | El-Gabalawy R, Crooks M, Smith MSD, Hammond E, Gross P, Roznik M, Perrin D, Reynolds K, Logan G, Pankratz L, Johnson H, Girling L, Wiebe D. Treating Lower Phantom Limb Pain in the Postoperative Acute Care Setting Using Virtual Reality: Protocol for a 4-Phase Development and Feasibility Trial. JMIR Res Protoc. 2025 May 23;14:e68008. doi: 10.2196/68008. |
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It is not typical to share the individual participant data from a feasibility study.
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| One month follow-up |
| Embodiment | Virtual Embodiment Questionnaire. Range 1-7 for 12 items, higher score = higher embodiment. | 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. | Administered after intervention administration is completed, up to seventeen days |
| Baseline |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |