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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-15-2-0071 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Naval Medical Center, San Diego | FED |
| Walter Reed National Military Medical Center | FED |
| Brooke Army Medical Center | FED |
| University of Illinois at Chicago |
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This study will train War Fighters with lower extremity trauma to decrease fall risk.
Eligible active duty service members, retired or veterans who participated in rehabilitation programs at Department of Defense Advanced Rehabilitation Centers (Walter Reed National Military Medical Center, Center for the Intrepid-San Antonio Military Medical Center and/or the Naval Medical Center San Diego) will be considered for enrollment in this study. This study will look at service members who have undergone transfemoral, transtibial or bilateral lower extremity amputation or limb salvage procedures. Participants will receive fall prevention training on an instrumented treadmill (6, training sessions). Participants will receive three performance assessments:-immediately following completion of the treadmill training and at three and six months following the completion of the training. Post training, twice per month subjects will receive an email containing a follow up fall questionnaire monitoring if they have fallen and the circumstances surrounding their fall. If they do not have access to email, or if a timely response is not received from the email questionnaire which was sent out, subjects will be contacted by phone.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Trunk Position | Trunk Position (referenced to vertical) at recovery step completion | Change from baseline at 0, 3, and 6 months after completing training |
| Change in Trunk Velocity | Trunk Velocity at recovery step completion | Change from baseline at 0, 3, and 6 months after completing training |
| Measure | Description | Time Frame |
|---|---|---|
| Falls | Falls per month reported in the Prosthesis Evaluation Questionnaire - Addendum | Change from baseline at 0, 3, and 6 months after completing training |
| FSST | Four-Square Step Test |
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Inclusion Criteria:
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This study plans to recruit both male and female military beneficiaries with a unilateral or bilateral transtibial or transfemoral amputation or salvaged and preserved limbs. The subjects will be present or past patients in the Naval Medical Center San Diego, C5 Rehabilitation Program, Center for the Intrepid Rehabilitation Program or Walter Reed National Military Medical Center Rehabilitation Program. Subjects will be contacted by the respective site study coordinator and asked to participate in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States | ||
| Walter Reed National Military Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22372753 | Background | Armed Forces Health Surveillance Center (AFHSC). Medical evacuations from Operation Iraqi Freedom/Operation New Dawn, active and reserve components, U.S. Armed Forces, 2003-2011. MSMR. 2012 Feb;19(2):18-21. | |
| 23324961 | Background | Doukas WC, Hayda RA, Frisch HM, Andersen RC, Mazurek MT, Ficke JR, Keeling JJ, Pasquina PF, Wain HJ, Carlini AR, MacKenzie EJ. The Military Extremity Trauma Amputation/Limb Salvage (METALS) study: outcomes of amputation versus limb salvage following major lower-extremity trauma. J Bone Joint Surg Am. 2013 Jan 16;95(2):138-45. doi: 10.2106/JBJS.K.00734. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| OTHER |
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| Change from baseline at 0, 3, and 6 months after completing training |
| Bethesda |
| Maryland |
| 20889 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Center for the Intrepid Brooke Army Medical Center | San Antonio | Texas | 78234 | United States |
| 15180121 | Background | Gooday HM, Hunter J. Preventing falls and stump injuries in lower limb amputees during inpatient rehabilitation: completion of the audit cycle. Clin Rehabil. 2004 Jun;18(4):379-90. doi: 10.1191/0269215504cr738oa. |
| 16715022 | Background | Pauley T, Devlin M, Heslin K. Falls sustained during inpatient rehabilitation after lower limb amputation: prevalence and predictors. Am J Phys Med Rehabil. 2006 Jun;85(6):521-32; quiz, 533-5. doi: 10.1097/01.phm.0000219119.58965.8c. |
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| 24744130 | Background | Bedigrew KM, Patzkowski JC, Wilken JM, Owens JG, Blanck RV, Stinner DJ, Kirk KL, Hsu JR; Skeletal Trauma Research Consortium (STReC). Can an integrated orthotic and rehabilitation program decrease pain and improve function after lower extremity trauma? Clin Orthop Relat Res. 2014 Oct;472(10):3017-25. doi: 10.1007/s11999-014-3609-7. |
| 21477527 | Background | Patzkowski JC, Blanck RV, Owens JG, Wilken JM, Blair JA, Hsu JR. Can an ankle-foot orthosis change hearts and minds? J Surg Orthop Adv. 2011 Spring;20(1):8-18. |
| 22437999 | Background | Patzkowski JC, Blanck RV, Owens JG, Wilken JM, Kirk KL, Wenke JC, Hsu JR; Skeletal Trauma Research Consortium. Comparative effect of orthosis design on functional performance. J Bone Joint Surg Am. 2012 Mar 21;94(6):507-15. doi: 10.2106/JBJS.K.00254. |
| 23078248 | Background | Panwalkar N, Aruin AS. Role of ankle foot orthoses in the outcome of clinical tests of balance. Disabil Rehabil Assist Technol. 2013 Jul;8(4):314-20. doi: 10.3109/17483107.2012.721158. Epub 2012 Oct 19. |
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| Background | Ramstrand N and Ramstrand S. (2010). The effect of ankle-foot orthoses on balance - Asystematic Review. Journal of Prosthetics and Orthotics; 22(4S): p4-p23. |
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| Background | Shumway-Cook A, Woollacott MH. (1995). Motor learning and recovery of function. InMotor Control: Theory and Practical Application (pp. 23-443). Baltimore, MD:Williams & Wilkens. |
| 36794799 | Derived | Kaufman KR, Miller EJ, Deml CM, Sheehan RC, Grabiner MD, Wyatt M, Zai CZ, Kingsbury T, Tullos ML, Acasio JC, Mahon CE, Hendershot BD, Dearth CL. Fall Prevention Training for Service Members With an Amputation or Limb Salvage Following Lower Extremity Trauma. Mil Med. 2024 May 18;189(5-6):980-987. doi: 10.1093/milmed/usad005. |
| 36515906 | Derived | Acasio JC, Tullos ML, Mahon CE, Khatri BR, Kaufman KR, Dearth CL, Hendershot BD. A single-subject comparison of functional outcomes between lower limb salvage vs. transtibial amputation through sequential participation in a fall-prevention program. Prosthet Orthot Int. 2022 Dec 1;46(6):614-618. doi: 10.1097/PXR.0000000000000156. Epub 2022 Jun 7. |