Phantom Limb PainNCT06638918
Assessing the Feasibility of a Virtual Reality Intervention for Phantom Pain Immediately Following Lower Limb Amputation
An observational study of Phantom Limb Pain, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jul 2024to 5 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Feasibility of a Virtual Reality Intervention for Lower Phantom Limb Pain in the Acute Postoperative Period
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.
- Is this VR treatment acceptable to people immediately following lower limb amputation?
- 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?
- Do participants who use the VR program more have less severe PLP than participants who use the VR program for fewer sessions?
Read more
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.
Read the 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
- Being tested
- Virtual Reality
- Keywords
- virtual reality, phantom limb pain, lower limb amputation, graded motor imagery, feasibility, acute
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items.
Measured: 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.
Measured: Immediately before and after intervention administration
Engagement
Length of time in minutes spent in the virtual reality program per session (recommended: 20 minutes)
Measured: During intervention administration, up to seventeen days
Secondary outcomes (4)
Phantom Limb Pain Intensity
Brief Pain Inventory (Pain Intensity Only). Range 0-40, higher scores = higher pain intensity.
Measured: 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.
Measured: One month follow-up
Embodiment
Virtual Embodiment Questionnaire. Range 1-7 for 12 items, higher score = higher embodiment.
Measured: 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.
Measured: Administered after intervention administration is completed, up to seventeen days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start26 Jul 2024
- Primary completion17 Oct 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre, Winnipeg, Manitoba
- Responsible party
- Principal investigator, Renée El-Gabalawy, University of Manitoba
- Investigators
- Renee El-Gabalawy, PhD, Principal investigator, Associate Professor and Clinical Psychologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638918
- Sponsor's protocol ID
- HS25778
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: It is not typical to share the individual participant data from a feasibility study.
Publications
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.
PubMed 40409745
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of a Virtual Reality Intervention for Lower Phantom Limb Pain in the Acute Postoperative Period
- ClinicalTrials.gov ID
- NCT06638918
- Acronym / sponsor ID
- HS25778
- Conditions
- Phantom Limb Pain
- Keywords
- virtual reality, phantom limb pain, lower limb amputation, graded motor imagery, feasibility, acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Health Sciences Centre, Winnipeg, Manitoba
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Is this VR treatment acceptable to people immediately following lower limb amputation?
- 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?
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | – | Device: Virtual RealityThese participants will receive the virtual reality intervention for at least 20 minutes daily for approximately seventeen sessions, or as long as they are able. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityThe 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. | Device | Virtual Reality Group |
Primary outcome
Acceptability
Time frame: Immediately after intervention is administered
The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items.
Tolerability of the virtual reality simulation
Time frame: Immediately before and after intervention administration
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.
Engagement
Time frame: During intervention administration, up to seventeen days
Length of time in minutes spent in the virtual reality program per session (recommended: 20 minutes)
4 secondary outcomes
Phantom Limb Pain Intensity
Time frame: One month follow-up
Phantom Limb Pain Interference
Time frame: One month follow-up
Embodiment
Time frame: Administered after intervention administration is completed, up to seventeen days
Presence
Time frame: Administered after intervention administration is completed, up to seventeen days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Derived from this study: PubMed 40409745El-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.
- Individual participant dataSharing planned: No. It is not typical to share the individual participant data from a feasibility study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee El-Gabalawy, PhD principal investigator
Associate Professor and Clinical Psychologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phantom Limb Pain, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Immediately after intervention is administered). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06638918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.