Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain.Home-Based Treatment
NCT ID: NCT07044323
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
44 participants
INTERVENTIONAL
2025-06-16
2026-05-31
Brief Summary
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Detailed Description
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The investigators recently completed the in-person part of the study in which they compared the efficacy of Active VR treatment to Distractor VR treatment for PLP on measures of pain as well as psychological health and quality of life.
In the Active VR treatment, subjects played a variety of active games requiring leg movements while receiving high-quality visual feedback of the missing lower leg. Feedback about leg position was provided via the VR headset controller, and the program generated an image of the missing lower leg, visible as a first-person avatar. The "Distractor" treatment was the REAL i-Series® immersive VR experience: subjects navigated through a pleasant VR environment, without seeing any rendering of their body and making no movements with their legs. The results of the in-person study showed superior efficacy in reducing pain intensity of the Active Treatment as compared to the Distractor treatment.
The specific aim of the current study is to assess the feasibility and efficacy of a home-based, active VR treatment for PLP.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Home-based treatment
Self-administered Active Virtual Reality treatment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
100 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Albert Einstein Healthcare Network
OTHER
Responsible Party
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Laurel Buxbaum
Principal Investigator
Locations
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Jefferson Moss Rehabilitation Research Institute
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Slater M, Steed A, McCarthy J, Maringelli F. The influence of body movement on subjective presence in virtual environments. Hum Factors. 1998 Sep;40(3):469-77. doi: 10.1518/001872098779591368.
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Goller AI, Richards K, Novak S, Ward J. Mirror-touch synaesthesia in the phantom limbs of amputees. Cortex. 2013 Jan;49(1):243-51. doi: 10.1016/j.cortex.2011.05.002. Epub 2011 Jun 22.
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing. 1983 May;12(2):166-70. doi: 10.1093/ageing/12.2.166.
Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
Other Identifiers
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AEHN2022-775
Identifier Type: -
Identifier Source: org_study_id
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