Home-based virtual reality treatment for phantom leg pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with unilateral above- or below-knee amputations and persistent phantom limb pain will use an active virtual reality program at home that displays a first-person avatar leg and provides controller-based positional feedback while they play leg-moving games. Participants will be enrolled at sites in Philadelphia and Seattle and will use the home VR system for a defined treatment period with pain intensity, psychological health, and quality-of-life measures collected remotely. The active VR approach provides visual and sensorimotor feedback of the missing limb to encourage movement and cortical engagement, unlike distractor VR which offers passive navigation without limb representation. Investigators previously completed an in-person comparison in which active VR produced greater reductions in pain intensity than distractor VR.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 -100
* Capacity to provide Informed Consent
* Unilateral above or below knee amputation more than 3 months prior to enrollment
* Absence of cognitive impairment, operationally defined as a Montreal Cognitive Assessment score of 18 or greater1.
* Pain averaged over the preceding 1 month in the phantom limb rated as greater than 4 on a scale of 0-10.

Exclusion Criteria:

* History of significant medical or neurological disorder such as stroke or moderate to severe traumatic brain injury (operationally defined as loss of consciousness for more than 30 minutes)
* History of significant or poorly controlled psychiatric disorders
* Substantial depression or anxiety affecting their ability to perform tasks necessary for the study.
* Current abuse of alcohol or drugs, prescription or otherwise
* Nursing a child, pregnant, or intent to become pregnant during the study

Where it's running

• Jefferson Moss Rehabilitation Research Institute
  Philadelphia, Pennsylvania, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• University of Washington
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Laurel Buxbaum
• Email: Laurel.Buxbaum@jefferson.edu
• Phone: 215-663-6321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.