Transtibial Amputee Clinical Trial
Official title:
Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface
| Verified date | April 2023 |
| Source | University of Washington |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the proposed study is to conduct research on individuals with lower limb amputation, evaluating if residual limb fluid volume data collected using a novel non-invasive device is beneficial towards prosthetic prescription, fit, and comfort as determined by amputee test subjects and practitioners (prosthetists). Participants' residual limb fluid volume will be monitored through bioimpedance analysis both before and after a practitioner-issued modification to the prosthesis as an observational cohort study and then as a blinded randomized control trial in which the data may or may not be shared with the practitioner before the modification is made to the prosthesis.
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | December 23, 2020 |
| Est. primary completion date | September 14, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Transtibial amputees, unilateral or bilateral - 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: - Incidence of skin breakdown - Inability to ambulate continuously on a level walkway |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Washington Bioengineering | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| University of Washington |
United States,
Adragao T, Pires A, Branco P, Castro R, Oliveira A, Nogueira C, Bordalo J, Curto JD, Prata MM. Ankle--brachial index, vascular calcifications and mortality in dialysis patients. Nephrol Dial Transplant. 2012 Jan;27(1):318-25. doi: 10.1093/ndt/gfr233. Epub 2011 May 6. — View Citation
Andreoli A, Melchiorri G, De Lorenzo A, Caruso I, Sinibaldi Salimei P, Guerrisi M. Bioelectrical impedance measures in different position and vs dual-energy X-ray absorptiometry (DXA). J Sports Med Phys Fitness. 2002 Jun;42(2):186-9. — View Citation
Armstrong LE, Kenefick RW, Castellani JW, Riebe D, Kavouras SA, Kuznicki JT, Maresh CM. Bioimpedance spectroscopy technique: intra-, extracellular, and total body water. Med Sci Sports Exerc. 1997 Dec;29(12):1657-63. doi: 10.1097/00005768-199712000-00017. Erratum In: Med Sci Sports Exerc 1998 Jul;30(7):1178. — View Citation
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. — View Citation
Dittmar M. Reliability and variability of bioimpedance measures in normal adults: effects of age, gender, and body mass. Am J Phys Anthropol. 2003 Dec;122(4):361-70. doi: 10.1002/ajpa.10301. — View Citation
Donadio C, Consani C, Ardini M, Bernabini G, Caprio F, Grassi G, Lucchesi A, Nerucci B. Estimate of body water compartments and of body composition in maintenance hemodialysis patients: comparison of single and multifrequency bioimpedance analysis. J Ren Nutr. 2005 Jul;15(3):332-44. doi: 10.1016/j.jrn.2005.04.001. — View Citation
Fuller NJ, Hardingham CR, Graves M, Screaton N, Dixon AK, Ward LC, Elia M. Predicting composition of leg sections with anthropometry and bioelectrical impedance analysis, using magnetic resonance imaging as reference. Clin Sci (Lond). 1999 Jun;96(6):647-57. — View Citation
Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil. 2003 Nov 18;25(22):1278-80. doi: 10.1080/09638280310001603983. — View Citation
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. — View Citation
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. — View Citation
Legro MW, Reiber GD, Smith DG, del Aguila M, Larsen J, Boone D. Prosthesis evaluation questionnaire for persons with lower limb amputations: assessing prosthesis-related quality of life. Arch Phys Med Rehabil. 1998 Aug;79(8):931-8. doi: 10.1016/s0003-9993(98)90090-9. — View Citation
Organ LW, Bradham GB, Gore DT, Lozier SL. Segmental bioelectrical impedance analysis: theory and application of a new technique. J Appl Physiol (1985). 1994 Jul;77(1):98-112. doi: 10.1152/jappl.1994.77.1.98. — View Citation
Owings MF, Kozak LJ. Ambulatory and inpatient procedures in the United States, 1996. Vital Health Stat 13. 1998 Nov;(139):1-119. — View Citation
Pezzin LE, Dillingham TR, Mackenzie EJ, Ephraim P, Rossbach P. Use and satisfaction with prosthetic limb devices and related services. Arch Phys Med Rehabil. 2004 May;85(5):723-9. doi: 10.1016/j.apmr.2003.06.002. — View Citation
Potier L, Abi Khalil C, Mohammedi K, Roussel R. Use and utility of ankle brachial index in patients with diabetes. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):110-6. doi: 10.1016/j.ejvs.2010.09.020. Epub 2010 Nov 20. — View Citation
Redfield MT, Cagle JC, Hafner BJ, Sanders JE. Classifying prosthetic use via accelerometry in persons with transtibial amputations. J Rehabil Res Dev. 2013;50(9):1201-12. doi: 10.1682/JRRD.2012.12.0233. — View Citation
Salinari S, Bertuzzi A, Mingrone G, Capristo E, Scarfone A, Greco AV, Heymsfield SB. Bioimpedance analysis: a useful technique for assessing appendicular lean soft tissue mass and distribution. J Appl Physiol (1985). 2003 Apr;94(4):1552-6. doi: 10.1152/japplphysiol.00571.2002. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Sanders JE, Fatone S. Residual limb volume change: systematic review of measurement and management. J Rehabil Res Dev. 2011;48(8):949-86. doi: 10.1682/jrrd.2010.09.0189. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Sanders JE, Rogers EL, Abrahamson DC. Assessment of residual-limb volume change using bioimpedence. J Rehabil Res Dev. 2007;44(4):525-35. doi: 10.1682/jrrd.2006.08.0096. — View Citation
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. — View Citation
Segal KR, Burastero S, Chun A, Coronel P, Pierson RN Jr, Wang J. Estimation of extracellular and total body water by multiple-frequency bioelectrical-impedance measurement. Am J Clin Nutr. 1991 Jul;54(1):26-9. doi: 10.1093/ajcn/54.1.26. — View Citation
Siconolfi SF, Gretebeck RJ, Wong WW, Pietrzyk RA, Suire SS. Assessing total body and extracellular water from bioelectrical response spectroscopy. J Appl Physiol (1985). 1997 Feb;82(2):704-10. doi: 10.1152/jappl.1997.82.2.704. — View Citation
Van Loan MD, Withers P, Matthie J, Mayclin PL. Use of bioimpedance spectroscopy to determine extracellular fluid, intracellular fluid, total body water, and fat-free mass. Basic Life Sci. 1993;60:67-70. doi: 10.1007/978-1-4899-1268-8_13. No abstract available. — View Citation
Wotton MJ, Thomas BJ, Cornish BH, Ward LC. Comparison of whole body and segmental bioimpedance methodologies for estimating total body water. Ann N Y Acad Sci. 2000 May;904:181-6. doi: 10.1111/j.1749-6632.2000.tb06444.x. — View Citation
Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005. — View Citation
* Note: There are 31 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Significant Increases in Socket Comfort Score (SCS) | Participants are asked to quantify the overall comfort of their prosthesis by giving it a score between 0 and 10 with 0 as the least comfortable possible and 10 being the most comfortable possible. SCS scores were acquired both pre and post making modifications to the participant's prosthesis. For analysis purposes, the number of participants that had a significant positive change are counted for this outcome. Participants that had little to no change (a score difference <2) in SCS or had a negative change in SCS score were not counted. | Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks. | |
| Secondary | Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis | Participants are asked to indicate their overall satisfaction with their prosthesis by drawing a line on a continuous scale running from extremely unhappy to extremely happy (0 to 100). For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted. | Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks. | |
| Secondary | Number of Participants With Net-Positive Change in Ambulation Score | Participants are asked to indicate their overall ability to walk with their prosthesis by drawing a line on a continuous scale running from "Cannot Walk at All" to "No Problem Walking" (0 to 100, respectively). They are also asked questions related to ambulation ability in unique circumstances, such as walking in close spaces, up and down stairs, up and down hills, on streets, on sidewalks, and on slippery surfaces. For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted. | Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks. | |
| Secondary | Number of Participants With Net-Positive Change in Residual Limb Health Score | Participants are asked to indicate how much their residual limb sweats, smells, swells, develops rashes, develops ingrown hairs, and develops blisters, while wearing their prosthesis.They indicate this by drawing a line on a continuous scale running from "Extreme Amount" to "Not At All" (0 to 100, respectively). For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted. | Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks. | |
| Secondary | Number of Participants With Net-Positive Change in Prosthesis Utility Score | Participants are asked to indicate various features related to the utility of their prosthesis by drawing a line on a continuous scale that ranges from "Terrible" to "Excellent" (0 to 100, respectively). Features include prosthesis fit, weight, comfort while standing, comfort while sitting, balance, effort, feel, and donning. For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted. | Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks. | |
| Secondary | Number of Participants With Net-Positive Change in Prosthesis Well Being Score | Prosthesis users indicate their well being since their amputation and also rank their overall quality of life by marking a line on a scale ranging from "worst possible life" to "best possible life" (0 to 100, respectively). Participants who showed a positive net increase in this category were counted for each aim. | Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks. | |
| Secondary | Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient | Participants' prosthetists are asked to rate their ability to communicate the need for sock or behavioral changes to their patients participating in the study. They will indicate the score using a scale from 0 to 10 with 10 being the best possible communication and 0 being the worst possible communication. | Baseline, prior to socket modification | |
| Secondary | Types of Socket Modifications Implemented Per Group | Participants' prosthetists are asked the type of socket modification(s) that they implemented in free response format. Responses were simplified into 5 categories related to common modification changes. The most common themes were: fabrication of a new socket, addition of socket pads or an insert, creating socket reliefs, changing socket suspension, and other. Changes that fell under the "other" category were not necessarily related to changes in socket shape, such as changes in overall prosthesis alignment, prosthesis foot, fabrication materials, etc. | Baseline, prior to socket modification | |
| Secondary | Effect of Socket Modification, Measured by the Impact of the Physical Modification Made to the Prosthesis to Socket Fit | Participants' prosthetists from both groups were asked to rate the effectiveness of the modification(s) that they implemented on a scale of 0 to 10 in which 10 is "Excellent" and 0 is "Terrible". | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Strategies Recommended to Minimize Limb Fluid Volume Loss | Participants' prosthetists are asked what changes to the participant's volume management strategy they recommended in free-response format. The following common themes were pulled from their responses: new sock regimen, periodic doffing, new activity regimen, new self-care regimen, other, and none. A count for how many prosthetists mentioned the same theme was tabulated. | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit | Participants' prosthetists are asked to rate the effectiveness of the strategies that they recommended on a scale of 0 to 10 in which 10 is "Excellent" and 0 is "Terrible". | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed | Prosthetists are asked to rate their overall satisfaction with the socket modification and/or volume management change that was used for each participant by indicating a score from 0 to 10 with 10 being "Extremely Satisfied" and 0 being "Not Satisfied". | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given | Prosthetists are asked to describe their impression of the bioimpedance results in a free response format. Common themes were gathered from responses and a count for each was tabulated based on gathered responses. | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given | Prosthetists are asked to describe, in free response format how they used the bioimpedance results to inform their clinical practice. Common themes were gathered from responses and a count for each was tabulated based on gathered responses. | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Bioimpedance Usefulness for Socket Design, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications | Participants' prosthetists are asked to rate the effectiveness of the strategies that they recommended on a scale of 0 to 10 in which 10 is "Very Useful" and 0 is "Not Useful". | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Bioimpedance for Volume Management, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications | Prosthetists are asked to rate the utility of bioimpedance results in recommending volume management strategies to their patients. The rating scale is 0 to 10 with 10 being "Very Useful" and 0 being "Not Useful". | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Continuing Use of Bioimpedance Results, Measured by How Likely Clinicians Will be to Use Bioimpedance Data in the Future | Prosthetists are asked to indicate how likely they are to request bioimpedance data for their other patients by selecting a score from 0 to 10 with 10 with being "Very Likely" and 0 being "Not Likely at All". | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Impact of Bioimpedance, Measured by How Bioimpedance Data Changed the Way Prosthetists Approach Problem Issues of Socket Fit | Prosthetists are asked to quantify the impact that the bioimpedance had on the manner in which they approached the issue by rating the impact from 0 to 10 with 10 being "Very Impactful" and 0 being "No Impact". | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | Prosthetists are asked to select from a list which bioimpedance data was most useful to them. The list items are: magnitude of fluid volume change over the whole day, fluid volume change by regions of the limb, fluid volume change from different activities, rate of fluid volume change over the whole day, and rate of fluid volume change over specific activity intervals | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Bioimpedance and Communication Measured by General Feedback on Whether Prosthetist-patient Communication is Improved Through Use of Bioimpedance Data | Prosthetists are asked to indicate the degree to which their use bioimpedance results improved the communication between them and their patients. They indicate this by selecting a value from 0 to 10 with 10 being "Highly Impactful" and 0 being "No Impact". | Post modification, minimum 4 weeks after patient started study | |
| Secondary | Outcome Enhancement, Measured by the Degree to Which Outcomes Are Improved Using Bioimpedance Data | Prosthetists are asked to indicated the degree to which clinical outcomes were enhanced by the use of bioimpedance results. They indicate this by selecting a value from 0 to 10 with 10 being "Positive Impact" and 0 being "Negative Impact". | Post modification, minimum 4 weeks after patient started study |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04326712 -
The Effect of Different Measurement-manufacturing Techniques on Load Distribution in Amputees
|