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

NCT06638918 | Completed

• 1 other identifier: HS25778
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

• 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.

Conditions

Phantom Limb Pain

Keywords

virtual reality; phantom limb pain; lower limb amputation; graded motor imagery; feasibility; acute

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Phantom Limb Pain Intensity

  One month follow-up

• Phantom Limb Pain Interference

  One month follow-up

• Embodiment

  Administered after intervention administration is completed, up to seventeen days

• Presence

  Administered after intervention administration is completed, up to seventeen days

Other Outcomes (2)

• Anxiety

  Baseline

• Depression

  Baseline

Study Arms (1)

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.

Device: Virtual Reality

Interventions

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.

Virtual Reality Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Health Sciences Centre, Winnipeg, Manitoba: collaborator

Study Sites (1)

Health Sciences Center

Winnipeg, Manitoba, R3E 0Z2, Canada

Location

Related Publications (1)

• 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.

  PMID: 40409745 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Renee El-Gabalawy, PhD

  Associate Professor and Clinical Psychologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Clinical Psychologist

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: October 15, 2024
• Study Start: July 26, 2024
• Primary Completion: October 17, 2025
• Study Completion: January 5, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)