Transtibial AmputeeNCT03164356
Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees
A study testing Bioimpedance monitor in people with Transtibial Amputee, run by University of Washington at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transtibial Amputee
- What is being tested?
- Bioimpedance monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2016to 23 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Incidence of skin breakdown
- Inability to ambulate continuously on a level walkway
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Bioengineering
Seattle, Washington, 98105
About this study
Official title: Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface
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.
- Conditions
- Transtibial Amputee
- Being tested
- Bioimpedance monitor
- Keywords
- Limb Fluid Volume Management, Prosthetic Socket Modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioimpedance monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | 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. |
| Arm 2 - Experimental | 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. Receives: Device: Bioimpedance monitor |
| Arm 3 - Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Secondary outcomes (20)
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.
Measured: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
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.
Measured: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
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.
Measured: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
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.
Measured: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
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.
Measured: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
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.
Measured: Baseline, prior to socket modification
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.
Measured: Baseline, prior to socket modification
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".
Measured: Post modification, minimum 4 weeks after patient started study
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.
Measured: Post modification, minimum 4 weeks after patient started study
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".
Measured: Post modification, minimum 4 weeks after patient started study
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".
Measured: Post modification, minimum 4 weeks after patient started study
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.
Measured: Post modification, minimum 4 weeks after patient started study
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.
Measured: Post modification, minimum 4 weeks after patient started study
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".
Measured: Post modification, minimum 4 weeks after patient started study
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".
Measured: Post modification, minimum 4 weeks after patient started study
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".
Measured: Post modification, minimum 4 weeks after patient started study
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".
Measured: Post modification, minimum 4 weeks after patient started study
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
Measured: Post modification, minimum 4 weeks after patient started study
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".
Measured: Post modification, minimum 4 weeks after patient started study
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".
Measured: Post modification, minimum 4 weeks after patient started study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start9 Nov 2016
- Primary completion14 Sep 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Transtibial AmputeeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Sanders, University of Washington
- Investigators
- Joan E Sanders, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164356
- Sponsor's protocol ID
- STUDY00000969
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2017
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 22773260Legro 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.
PubMed 10659798Kavounoudias 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.
PubMed 15827911Sanders 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.
PubMed 24933719Sanders 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.
PubMed 22773526Sanders 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.
PubMed 22068373Van 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.
PubMed 8110166Organ 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.
PubMed 7961281Fuller 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.
PubMed 10334971Salinari 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.
PubMed 12626475Dittmar 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.
PubMed 14614757Andreoli 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.
PubMed 12032414Donadio 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.
PubMed 16007563Segal 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.
PubMed 2058583Wotton 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.
PubMed 10865733
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface
- ClinicalTrials.gov ID
- NCT03164356
- Acronym / sponsor ID
- STUDY00000969
- Conditions
- Transtibial Amputee
- Keywords
- Limb Fluid Volume Management, Prosthetic Socket Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Posted 22 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –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. |
| Arm 2 - Experimental | Experimental | Device: Bioimpedance monitorConclusions 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. |
| Arm 3 - Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Incidence of skin breakdown
- Inability to ambulate continuously on a level walkway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioimpedance monitorParticipant 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. | Device | Arm 2 - Experimental |
Primary outcome
Number of Participants With Significant Increases in Socket Comfort Score (SCS)
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
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.
20 secondary outcomes
Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Number of Participants With Net-Positive Change in Ambulation Score
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Number of Participants With Net-Positive Change in Residual Limb Health Score
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Number of Participants With Net-Positive Change in Prosthesis Utility Score
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Number of Participants With Net-Positive Change in Prosthesis Well Being Score
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient
Time frame: Baseline, prior to socket modification
Types of Socket Modifications Implemented Per Group
Time frame: Baseline, prior to socket modification
Effect of Socket Modification, Measured by the Impact of the Physical Modification Made to the Prosthesis to Socket Fit
Time frame: Post modification, minimum 4 weeks after patient started study
Strategies Recommended to Minimize Limb Fluid Volume Loss
Time frame: Post modification, minimum 4 weeks after patient started study
Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit
Time frame: Post modification, minimum 4 weeks after patient started study
Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed
Time frame: Post modification, minimum 4 weeks after patient started study
Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given
Time frame: Post modification, minimum 4 weeks after patient started study
Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given
Time frame: Post modification, minimum 4 weeks after patient started study
Bioimpedance Usefulness for Socket Design, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications
Time frame: Post modification, minimum 4 weeks after patient started study
Bioimpedance for Volume Management, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications
Time frame: Post modification, minimum 4 weeks after patient started study
Continuing Use of Bioimpedance Results, Measured by How Likely Clinicians Will be to Use Bioimpedance Data in the Future
Time frame: Post modification, minimum 4 weeks after patient started study
Impact of Bioimpedance, Measured by How Bioimpedance Data Changed the Way Prosthetists Approach Problem Issues of Socket Fit
Time frame: Post modification, minimum 4 weeks after patient started study
Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians
Time frame: Post modification, minimum 4 weeks after patient started study
Bioimpedance and Communication Measured by General Feedback on Whether Prosthetist-patient Communication is Improved Through Use of Bioimpedance Data
Time frame: Post modification, minimum 4 weeks after patient started study
Outcome Enhancement, Measured by the Degree to Which Outcomes Are Improved Using Bioimpedance Data
Time frame: Post modification, minimum 4 weeks after patient started study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22773260Sanders 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.
- Background: PubMed 10659798Legro 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.
- Background: PubMed 15827911Kavounoudias 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.
- Background: PubMed 24933719Sanders 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.
- Background: PubMed 22773526Sanders 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.
- Background: PubMed 22068373Sanders 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.
- Background: PubMed 8110166Van 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.
- Background: PubMed 7961281Organ 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.
- Background: PubMed 10334971Fuller 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.
- Background: PubMed 12626475Salinari 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.
- Background: PubMed 14614757Dittmar 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.
- Background: PubMed 12032414Andreoli 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.
- Sandia National Laboratories, Dynamic socketLink provided by the sponsor.
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Amputation
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
Active, not recruitingEarly Phase 1
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
Transtibial Amputee, Transtibial Amputation
Recruiting
Reliability and Validity of Continuous Inter-limb Stability
Amputation, Lower Limb
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan E Sanders, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioimpedance monitor in people with Transtibial Amputee, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Significant Increases in Socket Comfort Score (SCS) (time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03164356, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.