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

Not Applicable

Completed

Conditions: Transtibial Amputee

Interventions: Device: Bioimpedance monitor

Registration Number: NCT03164356

Lead Sponsor: University of Washington

Brief 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 (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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 68

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 2 - Experimental	Bioimpedance monitor	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Significant Increases in Socket Comfort Score (SCS)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis	Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.	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.
Number of Participants With Net-Positive Change in Ambulation Score	Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.	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.
Number of Participants With Net-Positive Change in Residual Limb Health Score	Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.	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.
Number of Participants With Net-Positive Change in Prosthesis Utility Score	Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.	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.
Number of Participants With Net-Positive Change in Prosthesis Well Being Score	Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.	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.
Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient	Baseline, prior to socket modification	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.
Types of Socket Modifications Implemented Per Group	Baseline, prior to socket modification	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.
Effect of Socket Modification, Measured by the Impact of the Physical Modification Made to the Prosthesis to Socket Fit	Post modification, minimum 4 weeks after patient started study	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".
Strategies Recommended to Minimize Limb Fluid Volume Loss	Post modification, minimum 4 weeks after patient started study	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.
Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit	Post modification, minimum 4 weeks after patient started study	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".
Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed	Post modification, minimum 4 weeks after patient started study	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".
Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given	Post modification, minimum 4 weeks after patient started study	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.
Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given	Post modification, minimum 4 weeks after patient started study	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.
Bioimpedance Usefulness for Socket Design, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications	Post modification, minimum 4 weeks after patient started study	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".
Bioimpedance for Volume Management, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications	Post modification, minimum 4 weeks after patient started study	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".
Continuing Use of Bioimpedance Results, Measured by How Likely Clinicians Will be to Use Bioimpedance Data in the Future	Post modification, minimum 4 weeks after patient started study	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".
Impact of Bioimpedance, Measured by How Bioimpedance Data Changed the Way Prosthetists Approach Problem Issues of Socket Fit	Post modification, minimum 4 weeks after patient started study	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".
Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians	Post modification, minimum 4 weeks after patient started study	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
Bioimpedance and Communication Measured by General Feedback on Whether Prosthetist-patient Communication is Improved Through Use of Bioimpedance Data	Post modification, minimum 4 weeks after patient started study	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".
Outcome Enhancement, Measured by the Degree to Which Outcomes Are Improved Using Bioimpedance Data	Post modification, minimum 4 weeks after patient started study	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".