- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04494555
Do Adaptable Sockets Improve Military Performance?
This is a repeated measures prospective study and is no greater than a minimal risk study. All study procedures will be conducted at the Center for the Intrepid (CFI) through collaborative efforts of the Military Performance Lab at the CFI and the Sanders lab at the University of Washington. Data collected at the CFI will be coded, compiled, and shared with the University of Washington investigators.The objective of the research is to test if microprocessor-adjusting sockets improve Service member performance in Military specific activities compared to (a) user- operated, motor-driven adjustable sockets (i.e. sockets users adjust themselves), and (b) static (traditional) sockets. Investigators also test if microprocessor-adjusting sockets better maintain socket fit and limb fluid volume, and if self-reported outcomes are more favorable than for user-operated or static sockets. The hypotheses to be tested include:
During intense Military specific tasks, compared to the user-adjusted socket and the static socket, the microprocessor-adjusting socket will:
- minimize translational movement between the residual limb and the prosthetic socket;
- maintain residual limb fluid volume; and
- maximize prosthetic socket comfort.
When using the microprocessor-adjusting socket compared to the user-adjusted socket and the static socket, participants will:
- cover the greatest distance during a simulated combat patrol;
- perform all high intensity Military specific tasks with less pain;
- perform a simulated combat patrol nearer to uninjured levels of performance; and
- rank usability at a level similar to the static socket.
The specific aims are to:
- Fabricate microprocessor-adjusting sockets specific for Service members and Veterans with goals of returning to high-level physical activities
Evaluate Military task performance in Service members with transtibial amputation using "Readiness Assessments," while wearing three socket configurations: microprocessor-adjusting, user-adjusting, and static
- Simulated combat patrol in a Virtual Realty Environment
- Military version of a Functional Capacity Evaluation
- Characterize user preference and usability of different socket configurations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the proposed research is to evaluate the use of microprocessor-adjusting sockets during "Readiness Assessments" of Military tasks performed by Service members with transtibial amputation.
Participants will come to the Center For the Intrepid (CFI) for up to 10 visits to complete a pre-monitoring session (assess residual limb health and gather information regarding limb fluid volume); socket fitting session(s) (fitting of three sockets- static socket, a user-adjusted socket, and microprocessor-adjusting socket); and for military readiness assessments for each of the three socket conditions.
Data across the three socket conditions (static socket, user adjusted socket, and Microprocessor-adjusting sockets) will be tested for normality. When it normality can be assumed, a single factor repeated measures ANOVA will test between socket conditions. Mauchly's Test of Sphericity was be used to test if the variance is significantly different across all of the conditions. If the sphericity condition is violated, a Greenhouse-Geisser adjustment will be applied. When a significance effect is detected, pairwise comparisons using a Tukey post-hoc will be performed to determine which conditions are significantly different. When normality cannot be assumed, a Kruskal-Wallis H test will be used. When a significance effect is detected, pairwise comparisons using a Mann-Whitney post-hoc while adjusting the p-value for multiple comparisons will be performed to determine which conditions are significantly different. Statistical significance will be set to p<0.05
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Molly Baumann, PhD
- Phone Number: 6144297945
- Email: molly.baumann.civ@mail.mil
Study Contact Backup
- Name: Cynthia Chaiyanam
- Phone Number: (210) 916-9194
- Email: cynthia.a.chaiyanam.civ@mail.mil
Study Locations
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Texas
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Fort Sam Houston, Texas, United States, 78234
- Recruiting
- Brooke Army Medical Center, Center for the Intrepid
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Contact:
- Walter L Childers, PhD
- Phone Number: 210-422-8695
- Email: walter.l.childers.civ@mail.mil
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Contact:
- Molly Baumann, PhD
- Email: molly.baumann.civ@mail.mil
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Sub-Investigator:
- Molly Baumann, PhD
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Principal Investigator:
- Walter L Childers, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females age 18 - 55 years
- Authorized to receive care at the Center for the Intrepid
- Unilateral or bilateral transtibial amputation
- Have experience performing military relevant tasks (e.g., Active duty Service Member or Veteran)
- Current prosthesis user
- Ability to comply with instructions associated with functional testing
- Able to provide written informed consent
Exclusion Criteria:
- Self-reported inability to safely ambulate for a minimum of twenty minutes continuously and unassisted
- History of medical or psychological disease that would preclude safe gait, load carriage, physical, or cognitive functional training or testing within a virtual reality environment as determined by the provider screening the subject (i.e. moderate/severe traumatic brain injury, stroke, renal failure, cardiac or pulmonary problems disease, severe anemia, and other medical conditions)
- Any injury sustained to the upper extremity which would preclude safe physical performance testing
- Self-reported Blindness
- Self-reported Pregnancy
- Self-reported Active infection
- Weight above 250 lbs (114 kg)
- Residual limb length shorter than 9cm as this is the minimum distance necessary to attach the bio-impendence sensors
- Score greater than 20% on the Modified Oswestry Low Back Pain Questionnaire as this will indicate greater than minimal disability due to low back pain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Adaptable Prosthetic Socket
Using measurements of limb-socket displacements from sensors embedded within the socket wall, adaptable sockets make small adjustments to socket size so as to maintain consistent displacements while prosthesis users are active.
They do not require the user to stop activity or to touch or modify the prosthesis, and they do not distract users from their objectives.
|
For the static socket configuration, both the microprocessor control and user control are disabled, and the panels are positioned in their flush configuration to create the user's as-prescribed socket shape.
Sockets are configured for user control by disabling automated control and enabling push buttons on the side of the socket to adjust socket size.
Each button push effects a socket size change of approximately 0.3% volume.
An upper button effects a socket size increase, and a lower button a socket size decrease.
The buttons are countersunk so reduce risk of accidental pushes, and they do not function unless the user is stationary.
An additional button push will not be executed until motor motion from the prior push has been completed.
If a button is continuously held then the motor will continue moving until the button is released.
Limits are set on cable length to ensure that sockets sizes threatening to the user's residual limb (too tight) are avoided.
The push buttons effect inner-loop control that operates completely within the mechanism, achieving high-resolution adjustment of cable length with minimal error.
A strategy for automatically controlling the size of the socket during walking to compensate for unknown changes in limb volume will be used.
The controller is essentially a regulator that continuously measures socket "fit," and adjusts the socket to maintain a prescribed reference set point.
Because the fit is automatically sustained, the prosthesis user is unaware of its operation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motion of the Residual Limb in the Socket
Time Frame: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.
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Angular movement between the residual limb and the prosthetic socket in the sagittal plane.
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Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.
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Motion of Residual Limb in the Socket
Time Frame: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.
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Translational movement between the residual limb and the prosthetic socket about the longitudinal axis of the prosthetic socket.
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Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.
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Self-report questionnaires of socket comfort
Time Frame: SCS recorded before after after each task during REDoP and FCE-M. Approximately 3 hours.
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Change in Socket Comfort Score (SCS) across the Readiness Evaluation during Simulated Dismounted Operations (REDoP) and modified Functional Capacity Evaluation-Military (FCE-M), 0-10 scale.
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SCS recorded before after after each task during REDoP and FCE-M. Approximately 3 hours.
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Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Time Frame: Assessment administered per condition. Approximately 55 minutes.
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Total distance traversed during REDoP assessment.
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Assessment administered per condition. Approximately 55 minutes.
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Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Time Frame: Recorded after each task during REDoP. Approximately 55 minutes.
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An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout REDoP.
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Recorded after each task during REDoP. Approximately 55 minutes.
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Functional Capacity Evaluation-Military (FCE-M) performance metrics
Time Frame: Assessment administered per condition. Approximately 30 minutes.
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Time to complete each sub-task of the FCE-M.
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Assessment administered per condition. Approximately 30 minutes.
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Functional Capacity Evaluation-Military (FCE-M) performance metrics
Time Frame: Recorded after each task during REDoP. Approximately 30 minutes.
|
An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout FCE-M.
|
Recorded after each task during REDoP. Approximately 30 minutes.
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Total score on the Post-Study System Usability Questionnaire
Time Frame: After each of the sessions with each socket condition, approximately 3 hours.
|
This is a 19-item instrument for assessing user satisfaction with system usability.
The items are 7-point graphic scales, anchored at the ends with the terms "Strongly agree" for 1, "Strongly disagree" for 7, and a "Not applicable" (N/A) point outside the scale.
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After each of the sessions with each socket condition, approximately 3 hours.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Time Frame: Recorded after each task during REDoP. Approximately 55 minutes.
|
Marksmanship during the simulated ambushes.
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Recorded after each task during REDoP. Approximately 55 minutes.
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Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Time Frame: Recorded during REDoP. Approximately 55 minutes.
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Heart rate.
|
Recorded during REDoP. Approximately 55 minutes.
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Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Time Frame: Recorded after each task during REDoP. 5-10 sec to respond and approximately 55 minutes in total.
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Rating of perceived exertion.
A standard 6-20 Borg scale will be used to collect the individual's Rating of Perceived Exertion.
Subject's will be asked throughout the session to "rate the difficulty of the task" based on their fatigue level using the Borg scale.
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Recorded after each task during REDoP. 5-10 sec to respond and approximately 55 minutes in total.
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Functional Capacity Evaluation-Military (FCE-M) performance metrics
Time Frame: Recorded during FCE-M. Approximately 30 minutes.
|
Heart rate.
|
Recorded during FCE-M. Approximately 30 minutes.
|
Functional Capacity Evaluation-Military (FCE-M) performance metrics
Time Frame: Recorded after each task during FCE-M. 5-10 sec to respond and approximately 30 minutes in total.
|
Rating of perceived exertion.
A standard 6-20 Borg scale will be used to collect the individual's Rating of Perceived Exertion.
Subject's will be asked throughout the session to "rate the difficulty of the task" based on their fatigue level using the Borg scale.
|
Recorded after each task during FCE-M. 5-10 sec to respond and approximately 30 minutes in total.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Walter L Childers, PhD, Extremity Trauma and Amputation Center of Excellence (EACE)
Publications and helpful links
General Publications
- Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil. 2003 Nov 18;25(22):1278-80. doi: 10.1080/09638280310001603983.
- Hill J, Timmis A. Exercise tolerance testing. BMJ. 2002 May 4;324(7345):1084-7. doi: 10.1136/bmj.324.7345.1084. No abstract available.
- Sanders JE, Severance MR, Allyn KJ. Computer-socket manufacturing error: how much before it is clinically apparent? J Rehabil Res Dev. 2012;49(4):567-82. doi: 10.1682/jrrd.2011.05.0097.
- Schnell MD BW. Management of pain in the amputee. . In: JH Bowker JM, ed. Atlas of Limb Prosthetics: Surgical, Prosthetic, and Rehabilitation Principles. 2nd ed. Chicago: Mosby-Year Book; 1982:689-706.
- Henrikson KM, Weathersby EJ, Larsen BG, Cagle JC, McLean JB, Sanders JE. An Inductive Sensing System to Measure In-Socket Residual Limb Displacements for People Using Lower-Limb Prostheses. Sensors (Basel). 2018 Nov 9;18(11):3840. doi: 10.3390/s18113840.
- Sanders JE, Garbini JL, McLean JB, Hinrichs P, Predmore TJ, Brzostowski JT, Redd CB, Cagle JC. A motor-driven adjustable prosthetic socket operated using a mobile phone app: A technical note. Med Eng Phys. 2019 Jun;68:94-100. doi: 10.1016/j.medengphy.2019.04.003. Epub 2019 Apr 23.
- Sanders JE, Zachariah SG, Jacobsen AK, Fergason JR. Changes in interface pressures and shear stresses over time on trans-tibial amputee subjects ambulating with prosthetic limbs: comparison of diurnal and six-month differences. J Biomech. 2005 Aug;38(8):1566-73. doi: 10.1016/j.jbiomech.2004.08.008.
- Larsen BG, McLean JB, Redd CB, Brzostowski JT, Allyn KJ, Sanders JE. How do socket size adjustments during ambulation affect residual limb fluid volume? Case study results. JPO: Journal of Prosthetics and Orthotics. 2019;31(1):58-66.
- McLean JB, Redd CB, Larsen BG, Garbini JL, Brzostowski JT, Hafner BJ, Sanders JE. Socket size adjustments in people with transtibial amputation: Effects on residual limb fluid volume and limb-socket distance. Clin Biomech (Bristol, Avon). 2019 Mar;63:161-171. doi: 10.1016/j.clinbiomech.2019.02.022. Epub 2019 Mar 2.
- Brzostowski JT, Larsen BG, Youngblood RT, Ciol MA, Hafner BJ, Gurrey CJ, McLean JB, Allyn KJ, Sanders JE. Adjustable sockets may improve residual limb fluid volume retention in transtibial prosthesis users. Prosthet Orthot Int. 2019 Jun;43(3):250-256. doi: 10.1177/0309364618820140. Epub 2019 Jan 10.
- Fernie GR, Holliday PJ. Volume fluctuations in the residual limbs of lower limb amputees. Arch Phys Med Rehabil. 1982 Apr;63(4):162-5.
- Larsen BG, Allyn KJ, Ciol MA, Sanders JE. Performance of a sensor to monitor socket fit: Comparison with practitioner clinical assessment. JPO: Journal of Prosthetics and Orthotics. 2019.
- Larsen BG, McLean JB, Allyn KJ, Brzostowski JT, Garbini JL, Sanders JE. How do transtibial residual limbs adjust to intermittent incremental socket volume changes? Prosthet Orthot Int. 2019 Oct;43(5):528-539. doi: 10.1177/0309364619864771. Epub 2019 Jul 24.
- Collinger J, Grindle G, Heiner C, et al. Roadmap for future amputee care research. Care of the Combat Amputee. Washington, DC: Borden Institute, Walter Reed Army Medical Center; 2009.
- Berke GM, Fergason J, Milani JR, Hattingh J, McDowell M, Nguyen V, Reiber GE. Comparison of satisfaction with current prosthetic care in veterans and servicemembers from Vietnam and OIF/OEF conflicts with major traumatic limb loss. J Rehabil Res Dev. 2010;47(4):361-71. doi: 10.1682/jrrd.2009.12.0193.
- Reiber GE, McFarland LV, Hubbard S, Maynard C, Blough DK, Gambel JM, Smith DG. Servicemembers and veterans with major traumatic limb loss from Vietnam war and OIF/OEF conflicts: survey methods, participants, and summary findings. J Rehabil Res Dev. 2010;47(4):275-97. doi: 10.1682/jrrd.2010.01.0009.
- Force BIT. Dismounted Complex Blast Injury. Paper presented at: Report of the Army Dismounted Complex Blast Injury Task Force2011.
- Sanders JE, Harrison DS, Allyn KJ, Myers TR, Ciol MA, Tsai EC. How do sock ply changes affect residual-limb fluid volume in people with transtibial amputation? J Rehabil Res Dev. 2012;49(2):241-56. doi: 10.1682/jrrd.2011.02.0022.
- Hinrichs P, Cagle JC, Sanders JE. A portable bioimpedance instrument for monitoring residual limb fluid volume in people with transtibial limb loss: A technical note. Med Eng Phys. 2019 Jun;68:101-107. doi: 10.1016/j.medengphy.2019.04.002. Epub 2019 Apr 22.
- Sanders JE, Moehring MA, Rothlisberger TM, Phillips RH, Hartley T, Dietrich CR, Redd CB, Gardner DW, Cagle JC. A Bioimpedance Analysis Platform for Amputee Residual Limb Assessment. IEEE Trans Biomed Eng. 2016 Aug;63(8):1760-70. doi: 10.1109/TBME.2015.2502060. Epub 2015 Nov 19.
- De Lorenzo A, Andreoli A, Matthie J, Withers P. Predicting body cell mass with bioimpedance by using theoretical methods: a technological review. J Appl Physiol (1985). 1997 May;82(5):1542-58. doi: 10.1152/jappl.1997.82.5.1542. Erratum In: J Appl Physiol 1997 Dec;83(6):followi.
- Fenech M, Jaffrin MY. Extracellular and intracellular volume variations during postural change measured by segmental and wrist-ankle bioimpedance spectroscopy. IEEE Trans Biomed Eng. 2004 Jan;51(1):166-75. doi: 10.1109/TBME.2003.820338.
- Hanai T. Electrical properties of emulsions in emulsion science. Sherman PH. 1968.
- Sanders JE, Cagle JC, Allyn KJ, Harrison DS, Ciol MA. How do walking, standing, and resting influence transtibial amputee residual limb fluid volume? J Rehabil Res Dev. 2014;51(2):201-12. doi: 10.1682/JRRD.2013.04.0085.
- Sanders JE, Cagle JC, Harrison DS, Myers TR, Allyn KJ. How does adding and removing liquid from socket bladders affect residual-limb fluid volume? J Rehabil Res Dev. 2013;50(6):845-60. doi: 10.1682/JRRD.2012.06.0121.
- Sanders JE, Allyn KJ, Harrison DS, Myers TR, Ciol MA, Tsai EC. Preliminary investigation of residual-limb fluid volume changes within one day. J Rehabil Res Dev. 2012;49(10):1467-78. doi: 10.1682/jrrd.2011.12.0236.
- Sanders JE, Harrison DS, Allyn KJ, Myers TR. Clinical utility of in-socket residual limb volume change measurement: case study results. Prosthet Orthot Int. 2009 Dec;33(4):378-90. doi: 10.3109/03093640903214067.
- Sanders JE, Harrison DS, Cagle JC, Myers TR, Ciol MA, Allyn KJ. Post-doffing residual limb fluid volume change in people with trans-tibial amputation. Prosthet Orthot Int. 2012 Dec;36(4):443-9. doi: 10.1177/0309364612444752. Epub 2012 May 15.
- Sanders JE, Harrison DS, Myers TR, Allyn KJ. Effects of elevated vacuum on in-socket residual limb fluid volume: case study results using bioimpedance analysis. J Rehabil Res Dev. 2011;48(10):1231-48. doi: 10.1682/jrrd.2010.11.0219.
- Sanders JE, Hartley TL, Phillips RH, Ciol MA, Hafner BJ, Allyn KJ, Harrison DS. Does temporary socket removal affect residual limb fluid volume of trans-tibial amputees? Prosthet Orthot Int. 2016 Jun;40(3):320-8. doi: 10.1177/0309364614568413. Epub 2015 Feb 20.
- Sanders JE, Redd CB, Cagle JC, Hafner BJ, Gardner D, Allyn KJ, Harrison DS, Ciol MA. Preliminary evaluation of a novel bladder-liner for facilitating residual limb fluid volume recovery without doffing. J Rehabil Res Dev. 2016;53(6):1107-1120. doi: 10.1682/JRRD.2014.12.0316.
- Sanders JE, Youngblood RT, Hafner BJ, Ciol MA, Allyn KJ, Gardner D, Cagle JC, Redd CB, Dietrich CR. Residual limb fluid volume change and volume accommodation: Relationships to activity and self-report outcomes in people with trans-tibial amputation. Prosthet Orthot Int. 2018 Aug;42(4):415-427. doi: 10.1177/0309364617752983. Epub 2018 Feb 5.
- Youngblood RT, Hafner BJ, Allyn KJ, Cagle JC, Hinrichs P, Redd C, Vamos AC, Ciol MA, Bean N, Sanders JE. Effects of activity intensity, time, and intermittent doffing on daily limb fluid volume change in people with transtibial amputation. Prosthet Orthot Int. 2019 Feb;43(1):28-38. doi: 10.1177/0309364618785729. Epub 2018 Jul 16.
- Swanson EC, McLean JB, Allyn KJ, Redd CB, Sanders JE. Instrumented socket inserts for sensing interaction at the limb-socket interface. Med Eng Phys. 2018 Jan;51:111-118. doi: 10.1016/j.medengphy.2017.11.006. Epub 2017 Dec 8.
- Cancio JM, Oliver RA, Yancosek KE. Functional Capacity Evaluation-Military: Program Description and Case Series. Mil Med. 2017 Jan;182(1):e1658-e1664. doi: 10.7205/MILMED-D-16-00072.
- Gailey R, Kristal A, Lucarevic J, Harris S, Applegate B, Gaunaurd I. The development and internal consistency of the comprehensive lower limb amputee socket survey in active lower limb amputees. Prosthet Orthot Int. 2019 Feb;43(1):80-87. doi: 10.1177/0309364618791620. Epub 2018 Aug 10.
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- Keen SM, Kutter CJ, Niles BL, Krinsley KE. Psychometric properties of PTSD Checklist in sample of male veterans. J Rehabil Res Dev. 2008;45(3):465-74. doi: 10.1682/jrrd.2007.09.0138.
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Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BAMC C.2020.007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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