Transtibial Amputee
Conditions
Keywords
Limb Fluid Volume Management, Prosthetic Socket Modification
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.
Interventions
DEVICEBioimpedance 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.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Pre and Post Modification Observation, 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. | 19 |
| Arm 2 - Treatment Group, Pre and Post Modification 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. | 16 |
| Arm 2 - Control Group, Pre and Post Modification 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. | 16 |
| Arm 2 - Treatment Group Prosthetists, Pre and Post Modifications Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well. | 8 |
| Arm 2 - Control Group Prosthetists, Pre and Post Modifications Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well. | 9 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 2 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 3 | 0 |
| Overall Study | Prosthetist unable to participate | 0 | 2 | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 1 | 0 | 0 |
| Overall Study | Study timeframe interrupted by Coronavirus disease 2019 (COVID-19) | 1 | 0 | 0 | 1 |
| Overall Study | Subject Incarcerated | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm 1 - Pre and Post Modification Observation, No Intervention | Arm 2 - Treatment Group, Pre and Post Modification | Arm 2 - Control Group, Pre and Post Modification | Arm 2 - Treatment Group Prosthetists, Pre and Post Modifications | Arm 2 - Control Group Prosthetists, Pre and Post Modifications | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 4 Participants | 0 Participants | 0 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 11 Participants | 12 Participants | 8 Participants | 9 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 15 Participants | 16 Participants | 8 Participants | 9 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 13 Participants | 13 Participants | 8 Participants | 9 Participants | 58 Participants |
| Region of Enrollment United States | 19 participants | 16 participants | 16 participants | 8 participants | 9 participants | 68 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 14 Participants | 7 Participants | 7 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 8 | 0 / 9 |
Outcome results
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.
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Population: Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | Number of Participants With Significant Increases in Socket Comfort Score (SCS) | 5 participants |
| Arm 2 - Treatment | Number of Participants With Significant Increases in Socket Comfort Score (SCS) | 6 participants |
| Arm 3 - Control | Number of Participants With Significant Increases in Socket Comfort Score (SCS) | 4 participants |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing in the Treatment group were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Bioimpedance and Communication Measured by General Feedback on Whether Prosthetist-patient Communication is Improved Through Use of Bioimpedance Data | 8.1 score on a scale |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post-modification testing in the Treatment group were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Bioimpedance for Volume Management, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications | 8.3 score on a scale |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing in the Treatment group were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Bioimpedance Usefulness for Socket Design, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications | 6.9 score on a scale |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing in the Treatment group were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Continuing Use of Bioimpedance Results, Measured by How Likely Clinicians Will be to Use Bioimpedance Data in the Future | 8.5 score on a scale |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification treatment group testing were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Effect of Socket Modification, Measured by the Impact of the Physical Modification Made to the Prosthesis to Socket Fit | 8.3 score on a scale |
| Arm 2 - Treatment | Effect of Socket Modification, Measured by the Impact of the Physical Modification Made to the Prosthesis to Socket Fit | 8.6 score on a scale |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing were included in this analysis. Note: two control group prosthetists did not provide an answer for this portion of the survey.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit | 6.3 score on a scale |
| Arm 2 - Treatment | Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit | 6.7 score on a scale |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing in the Treatment group were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Impact of Bioimpedance, Measured by How Bioimpedance Data Changed the Way Prosthetists Approach Problem Issues of Socket Fit | 5.9 score on a scale |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed | 8.4 score on a scale |
| Arm 2 - Treatment | Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed | 7.9 score on a scale |
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
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing in the Treatment group were included in this analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | magnitude of fluid volume change over the whole day | Identified as useful | 4 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | magnitude of fluid volume change over the whole day | Did not identify as useful | 4 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | fluid volume change by regions of the limb | Identified as useful | 3 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | fluid volume change by regions of the limb | Did not identify as useful | 5 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | fluid volume change from different activities | Identified as useful | 6 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | fluid volume change from different activities | Did not identify as useful | 2 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | rate of fluid volume change over the whole day | Identified as useful | 4 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | rate of fluid volume change over the whole day | Did not identify as useful | 4 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | rate of fluid volume change over specific activity intervals | Identified as useful | 4 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | rate of fluid volume change over specific activity intervals | Did not identify as useful | 4 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | Other (pressure mapping based on limb volume) | Identified as useful | 1 Participants |
| Arm 1 | Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians | Other (pressure mapping based on limb volume) | Did not identify as useful | 7 Participants |
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.
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Population: Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Number of Participants With Net-Positive Change in Ambulation Score | 11 Participants |
| Arm 2 - Treatment | Number of Participants With Net-Positive Change in Ambulation Score | 8 Participants |
| Arm 3 - Control | Number of Participants With Net-Positive Change in Ambulation Score | 8 Participants |
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.
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Population: Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Number of Participants With Net-Positive Change in Prosthesis Utility Score | 11 Participants |
| Arm 2 - Treatment | Number of Participants With Net-Positive Change in Prosthesis Utility Score | 9 Participants |
| Arm 3 - Control | Number of Participants With Net-Positive Change in Prosthesis Utility Score | 9 Participants |
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.
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Population: Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Number of Participants With Net-Positive Change in Prosthesis Well Being Score | 8 Participants |
| Arm 2 - Treatment | Number of Participants With Net-Positive Change in Prosthesis Well Being Score | 7 Participants |
| Arm 3 - Control | Number of Participants With Net-Positive Change in Prosthesis Well Being Score | 6 Participants |
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.
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Population: Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Number of Participants With Net-Positive Change in Residual Limb Health Score | 10 Participants |
| Arm 2 - Treatment | Number of Participants With Net-Positive Change in Residual Limb Health Score | 3 Participants |
| Arm 3 - Control | Number of Participants With Net-Positive Change in Residual Limb Health Score | 6 Participants |
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.
Time frame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Population: Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis | 8 Participants |
| Arm 2 - Treatment | Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis | 6 Participants |
| Arm 3 - Control | Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis | 6 Participants |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing in the Treatment group were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Outcome Enhancement, Measured by the Degree to Which Outcomes Are Improved Using Bioimpedance Data | 6.6 score on a scale |
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.
Time frame: Baseline, prior to socket modification
Population: Only participants that completed surveys both pre and post modifications to their patient's sockets were included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 | Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient | 9 score on a scale |
| Arm 2 - Treatment | Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient | 8.8 score on a scale |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing in the Treatment group were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1 | Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given | Found results helpful/interesting | 4 Participants |
| Arm 1 | Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given | Results aligned with physiological expectations | 3 Participants |
| Arm 1 | Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given | Results did not align with physiological expectations | 2 Participants |
| Arm 1 | Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given | Highlighted detail of results | 4 Participants |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing in the Treatment group were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1 | Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given | To discuss daily activity patterns with patient | 2 Participants |
| Arm 1 | Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given | To communicate socket management topics with patient | 3 Participants |
| Arm 1 | Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given | To communicate physiological issues with patient | 3 Participants |
| Arm 1 | Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given | To inform socket modifications | 2 Participants |
| Arm 1 | Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given | Unsure/Did Not Use | 1 Participants |
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.
Time frame: Post modification, minimum 4 weeks after patient started study
Population: Only participants who completed the survey and whose patients completed pre and post modification testing were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1 | Strategies Recommended to Minimize Limb Fluid Volume Loss | New Sock Regimen | 2 Participants |
| Arm 1 | Strategies Recommended to Minimize Limb Fluid Volume Loss | Periodic Doffing | 3 Participants |
| Arm 1 | Strategies Recommended to Minimize Limb Fluid Volume Loss | Activity Regimen | 0 Participants |
| Arm 1 | Strategies Recommended to Minimize Limb Fluid Volume Loss | Self-Care Regimen | 0 Participants |
| Arm 1 | Strategies Recommended to Minimize Limb Fluid Volume Loss | Other | 0 Participants |
| Arm 1 | Strategies Recommended to Minimize Limb Fluid Volume Loss | None | 2 Participants |
| Arm 2 - Treatment | Strategies Recommended to Minimize Limb Fluid Volume Loss | Other | 0 Participants |
| Arm 2 - Treatment | Strategies Recommended to Minimize Limb Fluid Volume Loss | New Sock Regimen | 3 Participants |
| Arm 2 - Treatment | Strategies Recommended to Minimize Limb Fluid Volume Loss | Self-Care Regimen | 0 Participants |
| Arm 2 - Treatment | Strategies Recommended to Minimize Limb Fluid Volume Loss | Periodic Doffing | 1 Participants |
| Arm 2 - Treatment | Strategies Recommended to Minimize Limb Fluid Volume Loss | None | 2 Participants |
| Arm 2 - Treatment | Strategies Recommended to Minimize Limb Fluid Volume Loss | Activity Regimen | 0 Participants |
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.
Time frame: Baseline, prior to socket modification
Population: Only participants who completed the survey and whose patients completed pre and post-modification testing were included in this analysis. Prosthetists' responses from both the control and treatment groups are counted for this metric. Some prosthetists had more than one participant in the study which may impact total counts for this metric.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1 | Types of Socket Modifications Implemented Per Group | New Socket | 9 Participants |
| Arm 1 | Types of Socket Modifications Implemented Per Group | Suspension change | 1 Participants |
| Arm 1 | Types of Socket Modifications Implemented Per Group | socket relief | 0 Participants |
| Arm 1 | Types of Socket Modifications Implemented Per Group | Other | 6 Participants |
| Arm 1 | Types of Socket Modifications Implemented Per Group | Socket pad/insert | 1 Participants |
| Arm 2 - Treatment | Types of Socket Modifications Implemented Per Group | Other | 1 Participants |
| Arm 2 - Treatment | Types of Socket Modifications Implemented Per Group | New Socket | 11 Participants |
| Arm 2 - Treatment | Types of Socket Modifications Implemented Per Group | Socket pad/insert | 3 Participants |
| Arm 2 - Treatment | Types of Socket Modifications Implemented Per Group | socket relief | 1 Participants |
| Arm 2 - Treatment | Types of Socket Modifications Implemented Per Group | Suspension change | 1 Participants |