Virtual Integrated Environment in Decreasing Phantom Limb Pain (VIE)
The purpose of this study is to determine if observing a virtual arm decreases phantom limb pain (PLP) in upper extremity amputees.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of the Efficacy of a Virtual Integrated Environment in Decreasing Phantom Limb Pain|
- Change in Phantom Limb Pain Severity [ Time Frame: Baseline (0 weeks) and 4 weeks ] [ Designated as safety issue: No ]Severity of PLP will be assessed using the Visual Analog Scale (VAS), which wil consist of a 10-cm horizontal line across which subjects will place a mark corresponding to the level of phantom limb pain he or she experiences. The distance in centimeters from the low end of the VAS to the subject's mark will be used as a numeric index of pain severity. The VAS score over 4 weeks of VIE treatment will be averaged and compared to the baseline VAS score at the start of treatment.
- Consistency of sEMG recordings [ Time Frame: Baseline (0 weeks) and 4 weeks ] [ Designated as safety issue: No ]The activation patterns of muscles on an around the residual limb will be recorded during the initial VIE therapy session using surface electrodes. The sEMG recordings after 4 weeks will be compared to the initial sEMG recordings at the start of VIE treatment. The change in sEMG signals over time will indicate how well patients are able to replicate muscle activation patterns between sessions in which they attempt to move the phantom arm in the same manner as the virtual arm.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Experimental: VIE Therapy||
Device: Virtual Integration Environment (VIE)
The John Hopkins University Applied Physics Laboratory Virtual Integration Environment (VIE) is a virtual reality system that allows patients to observe movement of a 3D virtual arm. The VIE also contains hardware and software for recording and processing surface electromyography (sEMG) signals from the residual limb.
Nearly all traumatic limb amputees will experience cognizance of a phantom limb and perceive a vivid impression that their lost limb is not only fully present, but also painful. The John Hopkins University Applied Physics Laboratory Virtual Integration Environment (VIE) is a highly flexible and adaptable virtual reality system that allows patients to observe movement of a 3D virtual arm. Using the VIE, recorded signals from the residual limb will be correlated to the desired motion of the phantom limb. We hope to correlate the consistency of these patterns with PLP to determine if increased control of the phantom limb leads to decreased PLP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462461
|Contact: Briana N. Perry, BAemail@example.com|
|Contact: Aimee L. Alphonso, BSfirstname.lastname@example.org|
|United States, Maryland|
|Walter Reed National Military Medical Center (WRNMMC)||Recruiting|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator: Paul F. Pasquina, MD, MC|
|Sub-Investigator: Briana N. Perry, BA|
|Sub-Investigator: Aimee L. Alphonso, BS|
|Principal Investigator:||Paul F Pasquina, MD, MC||Walter Reed National Military Medical Center (WRNMMC)|