Recruiting

VR Treatment

Sponsor:

Albert Einstein Healthcare Network

Code:

NCT07044323

Conditions

Phantom Pain Following Amputation of Lower Limb

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active Virtual Reality Treatment

Study Details

Brief summary:

After amputation of an arm or leg, up to 90% of subjects experience a "phantom limb", a phenomenon characterized by persistent feelings of the missing limb. Many subjects with a phantom limb experience intense pain in the missing extremity that is often poorly responsive to medications or other interventions. The study will explore the feasibility and efficacy of a home-based, active VR treatment for phantom limb pain (PLP).

Conditions

Phantom Pain Following Amputation of Lower Limb

Amputation

Study ID

NCT07044323

Start date

Jun 16, 2025

Status verified date

Aug, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

44 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Home-based treatment

Self-administered Active Virtual Reality treatment

Interventions

Active Virtual Reality Treatment

The self-administered active VR treatment will consist of 8 twice-weekly sessions, each approximately 1 hour in duration, during which subjects will participate in a variety of Virtual Reality active games that require leg movements while receiving high-quality visual feedback of the missing lower leg.

Primary outcome measure

  • Changes in pain intensity [ Time Frame: pre each intervention (8 sessions); immediately after each intervention (8 session); baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention. ]
  • Changes in pain quality of the McGill Short Form Questionnaire [ Time Frame: baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention ]

Central Contacts and Locations

Central contacts

Laurel Buxbaum

215-663-6321Laurel.Buxbaum@jefferson.edu

Locations

Jefferson Moss Rehabilitation Research Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19027

Contacts

Rand Williamson

215-663-6321Rand.Williamson@jefferson.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19122

Contacts

Elisabetta Ambron

215-573-4336eambron@pennmedicine.upenn.edu

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Jing-Sheng Li

215-663-6321jsli@uw.edu

More Information

Sponsor

Albert Einstein Healthcare Network

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Keywords

  • pain
  • phantom limb
  • lower limb amputation
  • treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Albert Einstein Healthcare Network on 2025-08-08.