Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees

Study Overview
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Brief Summary
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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.

Official Title
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Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface

Conditions
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Transtibial Amputee

Intervention / Treatment
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* Device: Bioimpedance monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1<br>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. | |
| Experimental: Arm 2 - Experimental<br>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. | Device: Bioimpedance monitor<br>* 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.<br>|
| No Intervention: Arm 3 - Control<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Limb Fluid Volume Management, Prosthetic Socket Modification