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The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making. The investigators will explore a range of outcomes that have been found to be important for prostheses users and specifically assess the claims made by device manufacturers. Thirty adults with a transfemoral amputation will participate in four test sessions; one with their clinically prescribed, laminated socket, and three with different adjustable sockets. This data will be used to test the following aims: 1) does socket design impact socket comfort and prosthetic satisfaction? 2) does socket design impact of prosthetic socket on patient mobility and confidence, 3) how does prosthetic socket design influences prosthetic use in the home?, and 4) Are individual characteristics associated with benefits of specific socket designs?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prescribed Laminated Socket | Sham Comparator | In this arm, participants will wear their clinically prescribed laminated socket. This period is approximately 2 weeks. |
|
| Adjustable Sockets | Experimental | In this condition, participants will be fitted with 3 different adjustable transfemoral sockets by a certified prosthetist. The order in which the sockets are fitted are randomized and the participant will spend approximately 4 weeks in each socket. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laminated Socket | Device | This is the currently prescribed socket the participant normally wears. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Socket Fit Comfort Score | The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?" | After at least 3 weeks of prosthetic socket use |
| Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | The PEQ consists of 82 items of which 41 items form nine subscales concerning Prosthesis Utility (UT), Residual Limb Health (RL), Appearance (AP), Sounds (SO), Ambulation (AM), Perceived Response (PR), Frustration (FR), Social Burden (SB), and Well-Being (WB). The remaining 41 items are analyzed as single items. These items are scored on a 100-mm visual analog scale with descriptors at the extremes (e.g. never and all the time). The scales are calculated as averages of the items on a metric from 0 to 100 with higher scores indicating better health. | After at least 3 weeks of prosthetic socket use |
| Activities Specific Balance Confidence Scale | The ABC scale is a 16-item self-reported measure scored on a rating scale from 0 to 100, with higher scores indicate greater balance confidence. An average score is calculated by adding all item scores and dividing by the total number of items. The ABC scale has demonstrate high internal consistency, good test-retest validity, and good construct validity in people with lower limb amputation. | After at least 3 weeks of prosthetic socket use |
| Mobility as Measured by the 10-meter Walk Test | The 10-m walk test measures elapsed time over 10 m from a standing start. Participants complete one practice trial and then two test trials. The outcome is the average speed walked during the two trials. | after at least 4 weeks of prosthetic socket use |
| Measure | Description | Time Frame |
|---|---|---|
| Prosthetic Wear Time | Participants will be given sensors to monitor how many times participants don and doff the prosthesis during the day. This sensor will be attached to each socket after the 3rd week of accommodation. This sensor will be worn for 1 week. | After at least 3 weeks of prosthetic socket use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deanna H Gates, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rosalind Franklin University | Chicago | Illinois | 60064 | United States | ||
| University of Michigan |
Participant data will be deidentified for publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Laminated, Then CJ, Then Infinite, Then Quatro | Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition. |
| FG001 | Laminated, Then CJ, Then Quatro, Then Infinite | Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition. |
| FG002 | Laminated, Then Infinite, Then CJ, Then Quatro | Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition. |
| FG003 | Laminated, Then Infinite, Then Quatro, Then CJ | Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition. |
| FG004 | Laminated, Then Quatro, Then Infinite, Then CJ | Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition. |
| FG005 | Laminated, Then Quatro, Then CJ, Then Infinite | Participants first complete testing with their prescribed prosthetic socket. Surveys were administered in the first visit, the participant completed functional testing, and then they wore wearable sensors for the subsequent week. They were then fit with each of three experimental sockets that they wore for a minimum of 4 weeks. Surveys were administered after three weeks and functional assessments occurred after 4 weeks. There was a 1-week washout between each condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Testing |
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| Washout 1 |
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| Experimental Socket #1 |
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| Wash-out 2 |
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| Experimental Socket #2 |
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| Wash-out 3 |
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| Experimental Socket #3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | This group represents all study participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Self reported age in years at time of enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Socket Fit Comfort Score | The Socket Fit Comfort Score (SCS) is a single question in which subjects are asks: "On a scale from 0-10, if 0 represents the most uncomfortable socket fit you can imagine and 10 represents the most comfortable socket fit, how would you score the comfort of the socket fit of your artificial limb at the moment?" | All participants who successfully wore the socket at home for three weeks are included. We also exclude baseline data from individuals who did not successfully complete at least one experimental socket. | Posted | Mean | Standard Error | units on a scale | After at least 3 weeks of prosthetic socket use |
|
over 4 weeks of prosthetic socket use, up to two months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laminated Socket | During this condition, participants wore their prescribed laminated socket. Three participants were prescribed CJ sockets, rather than laminated and instead were fit with a laminated socket by a study prosthetist for this condition. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Infections and infestations | Non-systematic Assessment | Physician reported that participant passed away. They were not in an experimental socket at the time as the study was on a pause for COVID-19. Cause of death is not known but a choice of organ system was made as there is no unknown category. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant developed a wound on their residual limb |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deanna Gates | University of Michigan | 7346472698 | gatesd@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2021 | Jul 16, 2025 | Prot_SAP_000.pdf |
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| Quatro | Device | The Quatro (Quorum) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist. |
|
| Infinite Socket | Device | The Infinite Socket (LiM Innovations) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist. |
|
| CJ Socket | Device | The CJ Socket (CJ Socket Technologies) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist. |
|
| Mobility as Measured by Timed Up and Go (TUG) |
The timed-up-and-go (TUG) assesses several aspects of mobility including getting out of a chair, walking 3 m, turning, and sitting down (Schoppen et al. 1999). The outcome is the time from buttocks off the chair to buttocks down. The best of three trials was recorded. |
| after at least 4 weeks of prosthetic socket use |
| Mobility as Measured by Five Times Sit To Stand (FTSTS) | FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance. | after at least 4 weeks of prosthetic socket use |
| Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form | The PLUS-M 12-item short form assess self-reported mobility. The questions are summed and the score is converted to a T-Score (e.g. 50 indicates the population mean with a standard deviation of 10). Values higher than 50 indicate self-reported mobility better than the average person with lower limb amputation, while those less than 50 are below the average. | After at least 3 weeks of prosthetic socket use |
| Time to Complete the L Test |
The L test is a modified version of the TUG which incorporates two transfers and four turns of which at least one would be to the opposite side. The fastest time out of three trials was recorded. |
| After 4 weeks of prosthetic socket use |
| Steps Per Day Taken at Home | Participants will wear accelerometers to measure their average step count per day over a one week time frame. Data will be collected after at least three weeks of socket use. | After three weeks of device use |
| Prosthetic Preference | The prosthetic preference questionnaire consisted of a single question which asked which socket the participant preferred on a 100 mm visual analog scale from their prescribed socket to the test socket. A score of 0 would be 100% preference for their prescribed socket while 100 mm represents 100% preference for the experimental socket. | After at least three weeks of prosthetic socket use. |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Self-reported race and ethnicity | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | CJ Socket | Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation. |
| OG002 | Quatro | Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado) |
| OG003 | Infinite Socket | Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA) |
|
|
|
| Primary | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | The PEQ consists of 82 items of which 41 items form nine subscales concerning Prosthesis Utility (UT), Residual Limb Health (RL), Appearance (AP), Sounds (SO), Ambulation (AM), Perceived Response (PR), Frustration (FR), Social Burden (SB), and Well-Being (WB). The remaining 41 items are analyzed as single items. These items are scored on a 100-mm visual analog scale with descriptors at the extremes (e.g. never and all the time). The scales are calculated as averages of the items on a metric from 0 to 100 with higher scores indicating better health. | All participants who successfully completed at least one experimental condition | Posted | Mean | 95% Confidence Interval | units on a scale | After at least 3 weeks of prosthetic socket use |
|
|
|
|
| Primary | Activities Specific Balance Confidence Scale | The ABC scale is a 16-item self-reported measure scored on a rating scale from 0 to 100, with higher scores indicate greater balance confidence. An average score is calculated by adding all item scores and dividing by the total number of items. The ABC scale has demonstrate high internal consistency, good test-retest validity, and good construct validity in people with lower limb amputation. | All participants who successfully completed at least one experimental socket are included. One participants surveys for the laminated condition were lost in the mail. | Posted | Mean | Standard Error | units on a scale | After at least 3 weeks of prosthetic socket use |
|
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|
|
| Primary | Mobility as Measured by the 10-meter Walk Test | The 10-m walk test measures elapsed time over 10 m from a standing start. Participants complete one practice trial and then two test trials. The outcome is the average speed walked during the two trials. | All participants who successfully completed at least one experimental socket were included (n=23). Data is included for all participants who successfully wore the socket home for four weeks before dropping out of the study or failing the socket condition. | Posted | Mean | Standard Error | m/s | after at least 4 weeks of prosthetic socket use |
|
|
|
|
| Primary | Mobility as Measured by Timed Up and Go (TUG) | The timed-up-and-go (TUG) assesses several aspects of mobility including getting out of a chair, walking 3 m, turning, and sitting down (Schoppen et al. 1999). The outcome is the time from buttocks off the chair to buttocks down. The best of three trials was recorded. | All participants who successfully completed at least one experimental socket where included. For those 23 participants, only conditions where the participant wore the socket for four weeks are included | Posted | Mean | Standard Error | seconds | after at least 4 weeks of prosthetic socket use |
|
|
|
|
| Primary | Mobility as Measured by Five Times Sit To Stand (FTSTS) | FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance. | All participants who successfully completed at least one experimental socket were included (n=23). Data is included for all participants who successfully wore the socket home for four weeks before dropping out of the study or failing the socket condition. | Posted | Mean | Standard Error | seconds | after at least 4 weeks of prosthetic socket use |
|
|
|
| Primary | Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form | The PLUS-M 12-item short form assess self-reported mobility. The questions are summed and the score is converted to a T-Score (e.g. 50 indicates the population mean with a standard deviation of 10). Values higher than 50 indicate self-reported mobility better than the average person with lower limb amputation, while those less than 50 are below the average. | All participants who successfully completed at least one experimental socket were included (n=23). Data is included for all participants who successfully wore the socket home for three weeks before dropping out of the study or failing the socket condition. Surveys for one participant in the laminated condition were lost in the mail. | Posted | Mean | Standard Error | T Score | After at least 3 weeks of prosthetic socket use |
|
|
|
|
| Secondary | Prosthetic Wear Time | Participants will be given sensors to monitor how many times participants don and doff the prosthesis during the day. This sensor will be attached to each socket after the 3rd week of accommodation. This sensor will be worn for 1 week. | All participants with data. The data from the sensor was not reliable, so data was used from self report. | Posted | Mean | Standard Deviation | average number of times per day | After at least 3 weeks of prosthetic socket use |
|
|
|
| Secondary | Time to Complete the L Test | The L test is a modified version of the TUG which incorporates two transfers and four turns of which at least one would be to the opposite side. The fastest time out of three trials was recorded. | All participants who successfully completed at least one experimental socket were included (n=23). Data is included for all participants who successfully wore the socket home for four weeks before dropping out of the study or failing the socket condition. | Posted | Mean | Standard Error | seconds | After 4 weeks of prosthetic socket use |
|
|
|
|
| Secondary | Steps Per Day Taken at Home | Participants will wear accelerometers to measure their average step count per day over a one week time frame. Data will be collected after at least three weeks of socket use. | All participants with at least one full day of accelerometer data. | Posted | Mean | Standard Deviation | steps/day | After three weeks of device use |
|
|
|
| Secondary | Prosthetic Preference | The prosthetic preference questionnaire consisted of a single question which asked which socket the participant preferred on a 100 mm visual analog scale from their prescribed socket to the test socket. A score of 0 would be 100% preference for their prescribed socket while 100 mm represents 100% preference for the experimental socket. | Data were compared to the participants prescribed socket, which was either laminated (n=26) or CJ (n=3). There is only data for individuals who successfully completed at least two conditions (i.e. baseline and experimental). Since this is a relative measure, there is less data than for other outcomes. For example, only individuals who were prescribed the CJ would have a value for the laminated condition. Several participants also did not complete this survey. | Posted | Mean | Standard Error | units on a scale | After at least three weeks of prosthetic socket use. |
|
|
|
| 1 |
| 28 |
| 1 |
| 28 |
| 2 |
| 28 |
| EG001 | CJ Socket | Participants were fitted with a CJ sail socket (CJ Socket Technologies, Beverly, MA). Three participants were prescribed CJ sails prior to the study initiation. | 0 | 25 | 0 | 25 | 13 | 25 |
| EG002 | Quatro | Participants were fitted with a Quatro socket (Quorum Prosthetics, Windsor, Colorado) | 0 | 20 | 1 | 20 | 7 | 20 |
| EG003 | Infinite Socket | Participant were fitted with an Infinite socket (LiM Innovations, San Francisco, CA) | 0 | 24 | 1 | 24 | 10 | 24 |
|
| Cancer | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | The participant experienced a reoccurrence of cancer so they dropped out of the study for treatment. |
|
| Hospitalization | Blood and lymphatic system disorders | Non-systematic Assessment | The participant experienced excessive swelling of their residual limb and was hospitalized. They had already been fit with the Infinite check socket but had not received the definitive and therefore was wearing their prescribed socket at the time. |
|
|
| Injurious fall requiring medical attention | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant experienced an injurious fall that resulted in them seeking medical attention |
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| Instability/Discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant experienced limb instability or discomfort that limited or prevented them from wearing the socket |
|
| Device Issues | Product Issues | Non-systematic Assessment | Participant reported experiencing issues with the socket such as loss of suspension, part of the socket breaking off, issues with components, etc. |
|
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| Perceived Response Subscale |
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| Social Burden Subscale |
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| Ambulation Subscale |
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| Prosthesis Utility Subscale |
|
| Residual Limb Health Subscale |
|
| Appearance Subscale |
|
| Sounds Subscale |
|
| Well-Being Subscale |
|
| 0.598 |
| Superiority |
Perceived Response |
| ANOVA | 0.072 | Superiority | Social Burden |
| ANOVA | 0.018 | Superiority | Ambulation Sub-scale |
| ANOVA | 0.037 | Superiority | Prosthesis Utility |
| ANOVA | 0.254 | Superiority | Residual Limb Health |
| ANOVA | 0.032 | Superiority | Appearance |
| ANOVA | 0.352 | Superiority | Sounds |
| ANOVA | .077 | Superiority | Well-being |