Trial Outcomes & Findings for Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees (NCT NCT03164356)
NCT ID: NCT03164356
Last Updated: 2023-05-03
Results Overview
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.
COMPLETED
NA
68 participants
Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
2023-05-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
Arm 2 - 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
15
|
17
|
17
|
|
Overall Study
COMPLETED
|
14
|
10
|
11
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
6
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
Arm 2 - 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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
3
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
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
Prosthetist unable to participate
|
0
|
2
|
1
|
0
|
Baseline Characteristics
Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees
Baseline characteristics by cohort
| Measure |
Arm 1 - Pre and Post Modification Observation, No Intervention
n=19 Participants
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 - Treatment Group, Pre and Post Modification
n=16 Participants
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.
|
Arm 2 - Control Group, Pre and Post Modification
n=16 Participants
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.
|
Arm 2 - Treatment Group Prosthetists, Pre and Post Modifications
n=8 Participants
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.
|
Arm 2 - Control Group Prosthetists, Pre and Post Modifications
n=9 Participants
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.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
67 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
58 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
8 participants
n=4 Participants
|
9 participants
n=21 Participants
|
68 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm 1
n=14 Participants
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 - Treatment
n=10 Participants
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.
Bioimpedance 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.
|
Arm 3 - Control
n=11 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Significant Increases in Socket Comfort Score (SCS)
|
5 participants
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm 1
n=14 Participants
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 - Treatment
n=10 Participants
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.
Bioimpedance 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.
|
Arm 3 - Control
n=11 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis
|
8 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm 1
n=14 Participants
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 - Treatment
n=10 Participants
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.
Bioimpedance 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.
|
Arm 3 - Control
n=11 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Net-Positive Change in Ambulation Score
|
11 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm 1
n=14 Participants
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 - Treatment
n=10 Participants
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.
Bioimpedance 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.
|
Arm 3 - Control
n=11 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Net-Positive Change in Residual Limb Health Score
|
10 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm 1
n=14 Participants
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 - Treatment
n=10 Participants
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.
Bioimpedance 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.
|
Arm 3 - Control
n=11 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Net-Positive Change in Prosthesis Utility Score
|
11 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm 1
n=14 Participants
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 - Treatment
n=10 Participants
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.
Bioimpedance 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.
|
Arm 3 - Control
n=11 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Net-Positive Change in Prosthesis Well Being Score
|
8 Participants
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, prior to socket modificationPopulation: Only participants that completed surveys both pre and post modifications to their patient's sockets were included in this analysis.
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.
Outcome measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
n=9 Participants
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.
Bioimpedance 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.
|
Arm 3 - Control
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.
|
|---|---|---|---|
|
Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient
|
9 score on a scale
Interval 8.0 to 10.0
|
8.8 score on a scale
Interval 7.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, prior to socket modificationPopulation: 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.
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.
Outcome measures
| Measure |
Arm 1
n=10 Participants
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 - Treatment
n=11 Participants
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.
Bioimpedance 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.
|
Arm 3 - Control
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.
|
|---|---|---|---|
|
Types of Socket Modifications Implemented Per Group
New Socket
|
9 Participants
|
11 Participants
|
—
|
|
Types of Socket Modifications Implemented Per Group
socket relief
|
0 Participants
|
1 Participants
|
—
|
|
Types of Socket Modifications Implemented Per Group
Other
|
6 Participants
|
1 Participants
|
—
|
|
Types of Socket Modifications Implemented Per Group
Socket pad/insert
|
1 Participants
|
3 Participants
|
—
|
|
Types of Socket Modifications Implemented Per Group
Suspension change
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification treatment group testing were included in this analysis.
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".
Outcome measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
n=9 Participants
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.
Bioimpedance 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.
|
Arm 3 - Control
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.
|
|---|---|---|---|
|
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
Interval 3.0 to 10.0
|
8.6 score on a scale
Interval 5.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification testing were included in this analysis.
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.
Outcome measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
n=9 Participants
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.
Bioimpedance 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.
|
Arm 3 - Control
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.
|
|---|---|---|---|
|
Strategies Recommended to Minimize Limb Fluid Volume Loss
Periodic Doffing
|
3 Participants
|
1 Participants
|
—
|
|
Strategies Recommended to Minimize Limb Fluid Volume Loss
Activity Regimen
|
0 Participants
|
0 Participants
|
—
|
|
Strategies Recommended to Minimize Limb Fluid Volume Loss
Self-Care Regimen
|
0 Participants
|
0 Participants
|
—
|
|
Strategies Recommended to Minimize Limb Fluid Volume Loss
Other
|
0 Participants
|
0 Participants
|
—
|
|
Strategies Recommended to Minimize Limb Fluid Volume Loss
None
|
2 Participants
|
2 Participants
|
—
|
|
Strategies Recommended to Minimize Limb Fluid Volume Loss
New Sock Regimen
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2 Participants
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3 Participants
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: 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.
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".
Outcome measures
| Measure |
Arm 1
n=8 Participants
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.
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Arm 2 - Treatment
n=7 Participants
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit
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6.3 score on a scale
Interval 0.0 to 8.0
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6.7 score on a scale
Interval 5.0 to 9.0
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification testing were included in this analysis.
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".
Outcome measures
| Measure |
Arm 1
n=8 Participants
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.
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Arm 2 - Treatment
n=9 Participants
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed
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8.4 score on a scale
Interval 7.0 to 10.0
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7.9 score on a scale
Interval 5.0 to 10.0
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.
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.
Outcome measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given
Found results helpful/interesting
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4 Participants
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—
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Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given
Results aligned with physiological expectations
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3 Participants
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—
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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
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2 Participants
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Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given
Highlighted detail of results
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4 Participants
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—
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—
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.
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.
Outcome measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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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
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2 Participants
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—
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—
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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
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3 Participants
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—
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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
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3 Participants
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—
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Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given
To inform socket modifications
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2 Participants
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Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given
Unsure/Did Not Use
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1 Participants
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—
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.
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".
Outcome measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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|---|---|---|---|
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Bioimpedance Usefulness for Socket Design, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications
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6.9 score on a scale
Interval 0.0 to 10.0
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—
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—
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post-modification testing in the "Treatment" group were included in this analysis.
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".
Outcome measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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|---|---|---|---|
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Bioimpedance for Volume Management, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications
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8.3 score on a scale
Interval 5.0 to 10.0
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—
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—
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.
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".
Outcome measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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|---|---|---|---|
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Continuing Use of Bioimpedance Results, Measured by How Likely Clinicians Will be to Use Bioimpedance Data in the Future
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8.5 score on a scale
Interval 6.0 to 10.0
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.
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".
Outcome measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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|---|---|---|---|
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Impact of Bioimpedance, Measured by How Bioimpedance Data Changed the Way Prosthetists Approach Problem Issues of Socket Fit
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5.9 score on a scale
Interval 0.0 to 10.0
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—
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—
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.
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 measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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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
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4 Participants
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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
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1 Participants
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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
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4 Participants
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—
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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
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4 Participants
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—
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—
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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
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3 Participants
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—
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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
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5 Participants
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—
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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
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6 Participants
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—
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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
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2 Participants
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—
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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
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4 Participants
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—
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—
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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
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4 Participants
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—
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—
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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
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4 Participants
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—
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—
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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
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7 Participants
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—
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.
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 measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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Bioimpedance and Communication Measured by General Feedback on Whether Prosthetist-patient Communication is Improved Through Use of Bioimpedance Data
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8.1 score on a scale
Interval 6.0 to 10.0
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—
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—
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SECONDARY outcome
Timeframe: Post modification, minimum 4 weeks after patient started studyPopulation: Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.
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".
Outcome measures
| Measure |
Arm 1
n=8 Participants
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 - Treatment
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.
Bioimpedance 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.
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Arm 3 - Control
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.
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|---|---|---|---|
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Outcome Enhancement, Measured by the Degree to Which Outcomes Are Improved Using Bioimpedance Data
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6.6 score on a scale
Interval 2.0 to 9.0
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Adverse Events
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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place