An interventional study of Distractor and Lower limb VR in Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury) and Phantom Limb Pain, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-16.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
Patients with limb amputations experience the sensation of the missing extremity, which is sometimes coupled with a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP). This study will test the use of virtual reality (VR) training as a possible treatment of PLP.
Approximately 90% of patients with limb amputations experience the persistent sensation of the missing extremity, a phenomenon known as phantom limb (PL). Most patients with PL also experience a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP).PLP is often attributed to a disruption of the primary sensory-motor representation, generating "noise" in the representation of the missing extremity, manifesting as pain. If loss of sensory feedback causes degradation of the these cortices, interventions that provide visual feedback about the missing extremity might fine-tune the primary sensory-motor cortices, thereby reducing pain. Within this framework, the present study explores the use of virtual reality (VR) training as a possible treatment of PLP. Twenty-five subjects with lower-limb amputation and chronic PLP will undergo a Virtual Reality (VR) treatment (17 one-hour sessions) consisting in two phases: a Distraction VR phase (5-7 sessions) in which they will explore VR environments using a joystick and a Lower-Limb VR treatment phase (10-12 sessions) in which they will participate in a variety of games and activities using their VR lower-limbs. A comprehensive battery for the assessment of the characteristics, intensity and the daily-life implication of PLP will be presented before and after the treatment and in three follow up testing sessions (1,4, 8 weeks). Furthermore, pain intensity will be assessed before and after each VR session. A dramatic reduction of PLP is expected after the VR treatment and that these beneficial effects remain stable in time.
5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.
This study's enrollment of 14 is below the median of 52 across 3,261 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
The training sessions consist of Phase 1 (Distractor VR) in which patients will explore VR environments and Phase 2 (Lower limb VR) in which they will play games using their VR lower-limbs.
Device: Distractor and Lower limb VR
In the first phase (A), subjects will receive the Distraction VR treatment during 5, 6, or 7 one-hour-long sessions occurring twice weekly. After the A phase, the remaining sessions (B phase) will consist of Lower-Limb VR treatment. This number includes a mean of 6 (range 5-7) phase A sessions and mean of 11 (range 10-12) phase B sessions.
Changes in the Brief Pain Inventory
The Brief Pain Inventory is a questionnaire which provide a description of the type and location of pain (question 1-2),the pain severity (question 3-6 pain rating scales with 0-10 range - with 10 indicating severe pain), of the current treatment for pain (question 7-8) and the pain interference in daily life (question 9- range from 0 to 10 with a maximum score of 10 indicating severe interference). A decrease (i.e. reduction in the scores) in pain severity and in the pain interference in daily activity is expected as consequence of the virtual reality training.
Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Changes in the McGill Pain Questionnaire
The McGill Pain Questionnaire is a questionnaire which provide a description of the type of pain using series of adjectives on of the pain severity, using a visual analogue scale (range of 0-100 range - with 100 indicating severe pain). A decrease in pain severity (decrease in the score in the visual analogue scale) is expected as consequence of the virtual reality training.
Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Changes in the Frenchay Activities Index
The the Frenchay Activities Index is a 15 items questionnaire, which investigate how often people perform certain daily activity (e.g. preparing meals), using a scale from 0 to 3, with a score of 3 indicating that the activity is performed frequently. An increase in the Frenchay Activities Index is expected as consequence of the virtual reality training.
Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Changes in the12-Item Short Form Health Survey
The12-Item Short Form Health Survey is a questionnaire which investigate the quality of emotional and physical heath of individuals. An improvement in the quality of the individuals' health is expected as consequence of the training.
Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Changes in the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale measures depression is a 14 questions scale, which measure the level of depression and anxiety (maximum score of 21 indicating abnormal performance). A decrease in the score in this scale is expected as consequence of the virtual reality training
Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Changes in the Limb deficiency and Phantom Limb questionnaire.
The Limb Deficiency and Phantom Limb questionnaire investigate qualitatively the phantom limb sensations.A reduction in the reported phantom limb sensation is expected as consequence of the virtual reality training
Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Changes in the 13-item Pain Catastrophizing scale
The 13-item Pain Catastrophizing scale assesses the level of negative thoughts and feeling associated with pain using a scale from 0-4 (score of 4 indicating highest frequency; maximum overall score 52). A reduction of the overall score is expected after the virtual reality training
Time frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Plan to share: No
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.