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

NCT ID: NCT06638918

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-26
• Study Completion Date: 2026-01-05

Brief 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.

Detailed Description

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.

Conditions

Phantom Limb Pain

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Virtual Reality

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Sciences Centre, Winnipeg, Manitoba

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Renée El-Gabalawy

Associate Professor & Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renee El-Gabalawy, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor and Clinical Psychologist

Locations

Health Sciences Center

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 40409745 (View on PubMed)

Other Identifiers

HS25778

Identifier Type: -

Identifier Source: org_study_id