Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees
NCT ID: NCT03164356
Last Updated: 2023-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2016-11-09
2020-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
SINGLE
Study Groups
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Arm 1
In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.
No interventions assigned to this group
Arm 2 - Experimental
Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.
Bioimpedance monitor
Participant in aim 1 will be monitored using the bioimpedance monitor. Data obtained from the arm 1 cohort will be used to inform socket modifications made for arm 2 cohort.
Arm 3 - Control
Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist.
No interventions assigned to this group
Interventions
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Bioimpedance monitor
Participant in aim 1 will be monitored using the bioimpedance monitor. Data obtained from the arm 1 cohort will be used to inform socket modifications made for arm 2 cohort.
Eligibility Criteria
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Inclusion Criteria
* Amputation at least 18 months prior
* Walking activity of at least 7 hours per week
* Medicare functional classification level of 2 or higher
* Residual limb length of at least 9 centimeters
* Detrimental impacts to socket fit caused by residual limb volume fluctuations
* Indication for augmented suspension, socket modification/change, sock application removal or activity modification
Exclusion Criteria
* Inability to ambulate continuously on a level walkway
18 Years
ALL
Yes
Sponsors
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University of Washington
OTHER
Responsible Party
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Joan Sanders
Professor, Bioengineering
Principal Investigators
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Joan E Sanders, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington Bioengineering
Seattle, Washington, United States
Countries
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References
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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.
Legro MW, Reiber G, del Aguila M, Ajax MJ, Boone DA, Larsen JA, Smith DG, Sangeorzan B. Issues of importance reported by persons with lower limb amputations and prostheses. J Rehabil Res Dev. 1999 Jul;36(3):155-63.
Kavounoudias A, Tremblay C, Gravel D, Iancu A, Forget R. Bilateral changes in somatosensory sensibility after unilateral below-knee amputation. Arch Phys Med Rehabil. 2005 Apr;86(4):633-40. doi: 10.1016/j.apmr.2004.10.030.
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, 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.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Sandia National Laboratories, Dynamic socket
Other Identifiers
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STUDY00000969
Identifier Type: -
Identifier Source: org_study_id
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