Virtual Integrated Environment in Decreasing Phantom Limb Pain (VIE)
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| First Received Date ICMJE | October 25, 2011 | ||||||||
| Last Updated Date | November 13, 2012 | ||||||||
| Start Date ICMJE | October 2011 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01462461 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Virtual Integrated Environment in Decreasing Phantom Limb Pain | ||||||||
| Official Title ICMJE | Pilot Study of the Efficacy of a Virtual Integrated Environment in Decreasing Phantom Limb Pain | ||||||||
| Brief Summary | The purpose of this study is to determine if observing a virtual arm decreases phantom limb pain (PLP) in upper extremity amputees. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Phantom Limb | ||||||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: VIE Therapy
Intervention: Device: Virtual Integration Environment (VIE) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 18 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01462461 | ||||||||
| Other Study ID Numbers ICMJE | 20448, W81XWH-09-2-0148 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Henry M. Jackson Foundation for the Advancement of Military Medicine | ||||||||
| Study Sponsor ICMJE | Henry M. Jackson Foundation for the Advancement of Military Medicine | ||||||||
| Collaborators ICMJE | Johns Hopkins University | ||||||||
| Investigators ICMJE |
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| Information Provided By | Henry M. Jackson Foundation for the Advancement of Military Medicine | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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