Amputation, Amputation; Traumatic, Leg, Lower
Conditions
Keywords
Socket, Transfemoral
Brief summary
The objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.
Detailed description
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?
Interventions
DEVICELaminated Socket
This is the currently prescribed socket the participant normally wears.
DEVICEQuatro
The Quatro (Quorum) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.
DEVICEInfinite Socket
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.
DEVICECJ Socket
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unilateral lower-limb amputation * Six months of independent ambulation * Own and regularly wear a prosthesis with socket * Minimum functional level of K2 on the Medicare Functional Classification Level (MFCL): corresponding to the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator
Exclusion criteria
* Pathology or injury of the intact limb * Medication that affects their ability to walk * Neurologic or cardiovascular disease * Significant vision problems * Suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a Legally Authorized Representative to facilitate communication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form | After at least 3 weeks of prosthetic socket use | 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. |
| Activities Specific Balance Confidence Scale | After at least 3 weeks of prosthetic socket use | 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. |
| Mobility as Measured by the 10-meter Walk Test | after at least 4 weeks of prosthetic socket use | 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. |
| Mobility as Measured by Timed Up and Go (TUG) | after at least 4 weeks of prosthetic socket use | 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. |
| Mobility as Measured by Five Times Sit To Stand (FTSTS) | after at least 4 weeks of prosthetic socket use | FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance. |
| Socket Fit Comfort Score | After at least 3 weeks of prosthetic socket use | 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? |
| Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | After at least 3 weeks of prosthetic socket use | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete the L Test | After 4 weeks of prosthetic socket use | 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. |
| Steps Per Day Taken at Home | After three weeks of device use | 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. |
| Prosthetic Preference | After at least three weeks of prosthetic socket use. | 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. |
| Prosthetic Wear Time | After at least 3 weeks of prosthetic socket use | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants This group represents all study participants | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Experimental Socket #2 | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 |
| Washout 1 | Death | 0 | 0 | 0 | 1 | 0 | 0 |
| Washout 1 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 |
| Wash-out 2 | Withdrawal by Subject | 1 | 0 | 0 | 2 | 0 | 1 |
| Wash-out 3 | Withdrawal by Subject | 1 | 0 | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 28 | 0 / 25 | 0 / 20 | 0 / 24 |
| other Total, other adverse events | 2 / 28 | 13 / 25 | 7 / 20 | 10 / 24 |
| serious Total, serious adverse events | 1 / 28 | 0 / 25 | 1 / 20 | 1 / 24 |
Outcome results
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.
Time frame: After at least 3 weeks of prosthetic socket use
Population: All participants who successfully completed at least one experimental socket are included. One participants surveys for the laminated condition were lost in the mail.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminated Socket | Activities Specific Balance Confidence Scale | 68.7 units on a scale | Standard Error 2.8 |
| CJ Socket | Activities Specific Balance Confidence Scale | 70.4 units on a scale | Standard Error 3.3 |
| Quatro | Activities Specific Balance Confidence Scale | 67.8 units on a scale | Standard Error 3.2 |
| Infinite Socket | Activities Specific Balance Confidence Scale | 68.8 units on a scale | Standard Error 3 |
p-value: 0.95ANOVA
Primary
Mobility as Measured by Five Times Sit To Stand (FTSTS)
FTSTS is a measure of functional mobility, lower limb strength, and dynamic balance.
Time frame: after at least 4 weeks of prosthetic socket use
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminated Socket | Mobility as Measured by Five Times Sit To Stand (FTSTS) | 24.9 seconds | Standard Error 1.1 |
| CJ Socket | Mobility as Measured by Five Times Sit To Stand (FTSTS) | 21.8 seconds | Standard Error 1.4 |
| Quatro | Mobility as Measured by Five Times Sit To Stand (FTSTS) | 24.0 seconds | Standard Error 1.4 |
| Infinite Socket | Mobility as Measured by Five Times Sit To Stand (FTSTS) | 23.9 seconds | Standard Error 1.3 |
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.
Time frame: after at least 4 weeks of prosthetic socket use
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminated Socket | Mobility as Measured by the 10-meter Walk Test | 1.06 m/s | Standard Error 0.03 |
| CJ Socket | Mobility as Measured by the 10-meter Walk Test | 1.09 m/s | Standard Error 0.03 |
| Quatro | Mobility as Measured by the 10-meter Walk Test | 1.07 m/s | Standard Error 0.03 |
| Infinite Socket | Mobility as Measured by the 10-meter Walk Test | 1.08 m/s | Standard Error 0.03 |
p-value: 0.853ANOVA
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.
Time frame: after at least 4 weeks of prosthetic socket use
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminated Socket | Mobility as Measured by Timed Up and Go (TUG) | 15.0 seconds | Standard Error 0.39 |
| CJ Socket | Mobility as Measured by Timed Up and Go (TUG) | 14.4 seconds | Standard Error 0.48 |
| Quatro | Mobility as Measured by Timed Up and Go (TUG) | 14.4 seconds | Standard Error 0.5 |
| Infinite Socket | Mobility as Measured by Timed Up and Go (TUG) | 15.1 seconds | Standard Error 0.45 |
p-value: 0.565ANOVA
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.
Time frame: After at least 3 weeks of prosthetic socket use
Population: All participants who successfully completed at least one experimental condition
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Laminated Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Appearance Subscale | 65.3 units on a scale |
| Laminated Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Residual Limb Health Subscale | 68.4 units on a scale |
| Laminated Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Well-Being Subscale | 67.9 units on a scale |
| Laminated Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Ambulation Subscale | 52.4 units on a scale |
| Laminated Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Social Burden Subscale | 70.0 units on a scale |
| Laminated Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Perceived Response Subscale | 85.1 units on a scale |
| Laminated Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Sounds Subscale | 65.2 units on a scale |
| Laminated Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Prosthesis Utility Subscale | 59.3 units on a scale |
| Laminated Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Frustration Subscale | 54.6 units on a scale |
| CJ Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Prosthesis Utility Subscale | 72.6 units on a scale |
| CJ Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Appearance Subscale | 76.7 units on a scale |
| CJ Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Residual Limb Health Subscale | 71.1 units on a scale |
| CJ Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Perceived Response Subscale | 90.0 units on a scale |
| CJ Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Frustration Subscale | 65.3 units on a scale |
| CJ Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Social Burden Subscale | 82.1 units on a scale |
| CJ Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Well-Being Subscale | 65.4 units on a scale |
| CJ Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Sounds Subscale | 78.5 units on a scale |
| CJ Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Ambulation Subscale | 66.6 units on a scale |
| Quatro | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Prosthesis Utility Subscale | 72.2 units on a scale |
| Quatro | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Frustration Subscale | 61.7 units on a scale |
| Quatro | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Perceived Response Subscale | 89.9 units on a scale |
| Quatro | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Social Burden Subscale | 79.8 units on a scale |
| Quatro | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Ambulation Subscale | 66.9 units on a scale |
| Quatro | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Residual Limb Health Subscale | 76.5 units on a scale |
| Quatro | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Appearance Subscale | 73.3 units on a scale |
| Quatro | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Sounds Subscale | 69.5 units on a scale |
| Quatro | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Well-Being Subscale | 77.2 units on a scale |
| Infinite Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Appearance Subscale | 62.1 units on a scale |
| Infinite Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Ambulation Subscale | 57.1 units on a scale |
| Infinite Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Social Burden Subscale | 77.9 units on a scale |
| Infinite Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Well-Being Subscale | 73.5 units on a scale |
| Infinite Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Sounds Subscale | 71.0 units on a scale |
| Infinite Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Perceived Response Subscale | 87.3 units on a scale |
| Infinite Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Residual Limb Health Subscale | 75.9 units on a scale |
| Infinite Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Prosthesis Utility Subscale | 62.9 units on a scale |
| Infinite Socket | Satisfaction and Quality of Life on the Prosthetic Evaluation Questionnaire (PEQ) | Frustration Subscale | 51.9 units on a scale |
Comparison: The null hypothesis was that all sockets would be the samep-value: 0.536ANOVA
p-value: 0.598ANOVA
p-value: 0.072ANOVA
p-value: 0.018ANOVA
p-value: 0.037ANOVA
p-value: 0.254ANOVA
p-value: 0.032ANOVA
p-value: 0.352ANOVA
p-value: 0.077ANOVA
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.
Time frame: After at least 3 weeks of prosthetic socket use
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminated Socket | Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form | 50.5 T Score | Standard Error 1 |
| CJ Socket | Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form | 50.6 T Score | Standard Error 1.1 |
| Quatro | Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form | 52.0 T Score | Standard Error 1.1 |
| Infinite Socket | Self-reported Mobility Using the Prosthetic Limb Users Survey of Mobility (PLUMS-M) 12-item Short Form | 49.4 T Score | Standard Error 1 |
p-value: 0.374ANOVA
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?
Time frame: After at least 3 weeks of prosthetic socket use
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminated Socket | Socket Fit Comfort Score | 7.0 units on a scale | Standard Error 0.5 |
| CJ Socket | Socket Fit Comfort Score | 7.4 units on a scale | Standard Error 0.6 |
| Quatro | Socket Fit Comfort Score | 7.9 units on a scale | Standard Error 0.4 |
| Infinite Socket | Socket Fit Comfort Score | 7.3 units on a scale | Standard Error 0.5 |
Comparison: The null hypothesis was that all sockets would have the same SCSp-value: 0.553ANOVA
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.
Time frame: After at least three weeks of prosthetic socket use.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminated Socket | Prosthetic Preference | 4 units on a scale | — |
| CJ Socket | Prosthetic Preference | 33.4 units on a scale | Standard Error 11.6 |
| Quatro | Prosthetic Preference | 48.3 units on a scale | Standard Error 11 |
| Infinite Socket | Prosthetic Preference | 37.4 units on a scale | Standard Error 9.6 |
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.
Time frame: After at least 3 weeks of prosthetic socket use
Population: All participants with data. The data from the sensor was not reliable, so data was used from self report.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminated Socket | Prosthetic Wear Time | 1.77 average number of times per day | Standard Deviation 0.837 |
| CJ Socket | Prosthetic Wear Time | 1.49 average number of times per day | Standard Deviation 1.7 |
| Quatro | Prosthetic Wear Time | 1.47 average number of times per day | Standard Deviation 0.53 |
| Infinite Socket | Prosthetic Wear Time | 1.05 average number of times per day | Standard Deviation 0.35 |
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.
Time frame: After three weeks of device use
Population: All participants with at least one full day of accelerometer data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminated Socket | Steps Per Day Taken at Home | 2526 steps/day | Standard Deviation 1857 |
| CJ Socket | Steps Per Day Taken at Home | 2238 steps/day | Standard Deviation 1842 |
| Quatro | Steps Per Day Taken at Home | 2224 steps/day | Standard Deviation 1626 |
| Infinite Socket | Steps Per Day Taken at Home | 2616 steps/day | Standard Deviation 1828 |
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.
Time frame: After 4 weeks of prosthetic socket use
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laminated Socket | Time to Complete the L Test | 33.1 seconds | Standard Error 0.8 |
| CJ Socket | Time to Complete the L Test | 32.2 seconds | Standard Error 1 |
| Quatro | Time to Complete the L Test | 31.2 seconds | Standard Error 1.1 |
| Infinite Socket | Time to Complete the L Test | 32.6 seconds | Standard Error 1 |
p-value: 0.574ANOVA