Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT06638918
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Feasibility of a Virtual Reality Intervention for Phantom Pain Immediately Following Lower Limb Amputation
Sponsor:
University of Manitoba
Organization:
Study Overview
Official Title:
Assessing the Feasibility of a Virtual Reality Intervention for Lower Phantom Limb Pain in the Acute Postoperative Period
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: