An interventional study of Active Virtual Reality Treatment in Phantom Pain Following Amputation of Lower Limb and Amputation, sponsored by Albert Einstein Healthcare Network. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Albert Einstein Healthcare Network · Not applicable, Interventional, and Treatment
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).
Almost 2 million people in the US have had an amputation and up to 90% of people with limb amputation experience the persistent sensation of the missing extremity, a phenomenon known as a "phantom limb"Additionally, a significant proportion of individuals with a phantom limb - up to 85% in some studies - experience persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (hereafter PLP). Although existing therapies provide pain relief in some cases, there is widespread agreement that current approaches fall short of bringing relief to most individuals with PLP
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's planned enrollment of 44 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Albert Einstein Healthcare Network is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Compared within Phantom Limb, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Self-administered Active Virtual Reality treatment
Behavioral: 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.
Changes in pain intensity
the change in phantom limb pain score pre and post each VR intervention, at baseline, after the VR intervention and in the follow-up sessions as assessed using an 11-point numerical rating pain scale (0 - minimum score/no pain; 10 maximum score/pain as bad as you can imagine) assessing the current PLP level.
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
The change in the phantom limb pain quality between baseline, post-intervention, and follow-up sessions using McGill Short Form Questionnaire that measures the characteristics of pain (e.g., throbbing, etc.) using a 4-point rating pain scale (0 - minimum score - none: better outcome /4 maximum score - severe: worse outcome).
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
Changes in average pain after the treatment
average pain intensity since the previous intervention on an 11-point numerical rating pain scale; (0 - minimum score/no pain; 10 maximum score/pain as bad as participants can imagine); higher scores indicate higher level of pain (worse outcome)
Time frame: up to 4 weeks
Changes in daily activities after the treatment
The Frenchay Activities Index (FAI): a scale measuring the physical function and daily activity that has excellent reliability in subjects with lower-limb amputation in predicting quality of life. 0 minimum score - 45 maximum score; higher scores indicate more daily activities (better outcome).
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
Changes in quality of life after the treatment
The 12-Item Short Form Health Survey (SF-12): a brief measure of quality of life and functional capacity that has been validated in patients with amputation and PLP. 0 minimum score - 100 maximum score. Higher scores indicate lower physical and mental health (worse outcome).
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
Changes in pain interference after the treatment
The Pain Interference Scale from the Brief Pain Inventory (BPI): this assesses the degree to which pain interferes with daily activities using a 0-10 numeric rating scale. 0 minimum score - 10 maximum score. Higher scores indicate higher pain interference (worse outcome).
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
Changes in depression and anxiety as effect of the treatment
The Hospital Anxiety and Depression Scale (HADS): the HADS is a 14- item measure assessing both depressive and anxiety symptoms. In addition to providing separate scores for anxiety and depression, the HADS also provides a measure of global negative affect. 0 minimum score - 42 maximum score. Higher scores indicate more depression and anxiety (worse outcome)
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
Changes in the pain catastrophizing after the treatment
The 13-item Pain Catastrophizing Scale: this scale investigates pain catastrophizing, which has been highly associated with pain severity and disability after amputation. 0 minimum score -52; Higher scores indicate higher tendency to catastrophizing (worse outcome)
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
Changes in insomnia after the treatment
Insomnia Severity Index: this is a 7-point scale that measure insomnia, a symptom associated with PLP. 0 minimum score - 28 maximum score; higher scores indicate more insomnia (worse outcome)
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
Perception of VR system
Technology Acceptance Scale (Morris et al., 1997): this is a 7-point scale that measure level of acceptance of the VR system. 0 minimum score - 133 maximum score; higher scores indicate low level of acceptance (worse score)
Time frame: baseline, pre-intervention
Usability of each game
System Usability Scale (SUS): Scale measuring the usability of each game; minimum score 10 - maximum score 50. Higher scores indicate less usability (worse outcome).
Time frame: immediately after the last intervention (session 8 of the intervention);
Simulator Sickness Questionnaire
Simulator Sickness Questionnaire, which test for the presence of symptoms of cybersickness (e.g., general discomfort) on a 4-point numerical rating scale (0 - minimum score/no symptom; 4 maximum score/severe symptom)
Time frame: day 1, day 8
Presence in VR
Brief Slater-Usoh-Steed Presence Questionnaire. 7 minimum score - 42 maximum score. Higher scores indicate more presence in the VR (better outcome)
Time frame: day 1, day 8
Changes in Phantom Limb and Phantom Limb Pain after the treatment
The Modified Limb Deficiency and Phantom Limb Questionnaire: this questionnaire assesses the usage of prosthesis (yes/no) and non-painful phantom limb experiences (presence/absence), including perceived position (e.g., presence/absence of telescoping) and ability to move the phantom (yes/no).
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
Treatment satisfaction
visual analogue scale that evaluates treatment satisfaction; 0 minimum score - 10 maximum score; Higher scores indicate more treatment satisfaction (better outcome)
Time frame: 1 week after the end of the intervention
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