Actively Recruiting
Home-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb Amputations
Led by VA Office of Research and Development · Updated on 2025-10-29
36
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phantom Limb Pain (PLP) is a common and challenging type of nerve pain experienced by many Veterans who have had lower limb amputations. This study aims to improve a mobile app that uses graded motor imagery (GMI) to help manage PLP in Veterans. The research focuses on refining the app and testing it in a pilot study to see how acceptable and feasible it is for Veterans to use at home, with the goal of informing future larger studies on this intervention. The intervention involves using a mobile app designed for graded motor imagery, which includes sequential activities such as limb laterality training, motor imagery, and mirror therapy. The study will first refine the app with 12 Veterans and then pilot test it with 36 Veterans who have unilateral below-knee amputations and moderate to severe PLP. Each Veteran will complete twelve sessions of the GMI intervention using the app in their home environment, followed by 3- and 6-month follow-up assessments. Participants will be involved in virtual study activities, including using the mobile app for their intervention sessions and completing assessments through telehealth. Researchers will measure the primary outcome of intervention acceptability and secondary outcomes related to pain interference and experiences. Semi-structured interviews will also be conducted to understand the benefits and challenges of using the app at home. The study is expected to last five years, with recruitment and follow-up completed within this period.
CONDITIONS
Brief Title
Home-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb Amputations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be a military Veteran
- At least 18 years old
- More than 1 year since unilateral below knee amputation
- Moderate or severe phantom limb pain with a score of 4 or higher on a 0-10 scale
- Stable medications for the past 2 weeks
- Willing and able to give informed consent
- Able to participate in telehealth activities using a personal device
You will not qualify if you...
- Unstable medical conditions such as uncontrolled diabetes or heart failure exacerbation
- Unstable mental illness or substance use disorder including active suicidality or psychosis
- Unable to give informed consent due to cognitive impairment
- Fibromyalgia or complex regional pain syndrome-like symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (virtual)
Duration - Approximately 6 weeks
Participants use the Graded Motor Imagery mobile app at home through twelve intervention sessions to address phantom limb pain.
12 sessions conducted virtually in the participant's home
Duration - Up to 6 months
Participants are followed up to assess their perspective on the Graded Motor Imagery mobile app and health outcomes at 3 and 6 months after intervention.
2 virtual follow-up visits at 3 and 6 months after intervention
Trial Site Locations
Total: 1 location
1
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309
Actively Recruiting
Research Team
T
Tonya L Rich, PhD MA BS
A
Andrew H Hansen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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