Trial Outcomes & Findings for Community Walking Trials: Comparing Prosthetic Feet (NCT NCT03703232)
NCT ID: NCT03703232
Last Updated: 2024-06-21
Results Overview
Self-report questionnaire. PEQ Subscales: The PEQ is a 9-scale instrument that has good psychometric properties and has been validated. The PEQ subscales have a range from 0 (worst) to 100 (best). PEQ subscales of residual limb health, ambulation, utility, and sounds were selected for this study and comprise a total of 24 visual analogue scale questions. ICC estimates for these subscales for the first and second administration ranged from 0.79 to 0.9.
COMPLETED
NA
31 participants
Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.
2024-06-21
Participant Flow
Participant milestones
| Measure |
Lower Extremity Amputees
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Community Walking Trials: Comparing Prosthetic Feet
Baseline characteristics by cohort
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.Population: All participants
Self-report questionnaire. PEQ Subscales: The PEQ is a 9-scale instrument that has good psychometric properties and has been validated. The PEQ subscales have a range from 0 (worst) to 100 (best). PEQ subscales of residual limb health, ambulation, utility, and sounds were selected for this study and comprise a total of 24 visual analogue scale questions. ICC estimates for these subscales for the first and second administration ranged from 0.79 to 0.9.
Outcome measures
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Ambulation Sub-Scale
|
4.2 score on a scale
Standard Deviation 12.9
|
PRIMARY outcome
Timeframe: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.Population: All
The intent of the CLASS is to provide greater insight into the cause of socket dissatisfaction compared to the Socket Comfort Score. To accomplish this, the CLASS includes 4 subcategories; 1) stability, 2) suspension, 3) comfort, and 4) appearance. Each subcategory contains 3-4 items scored using a 5-point scale that relate to common tasks such as standing, sitting, walking, and ascending and descending stairs. Scale range: 0-60 Values: 0 = worst outcome; 60 = best outcome Subscales:0-16
Outcome measures
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Comfort Scale
|
1.1 score on a scale
Standard Deviation 11.6
|
PRIMARY outcome
Timeframe: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.Population: All
The F8W was developed to represent walking skills used in everyday life, involving straight and curved paths in both right and left directions. It has been validated in older adult populations with mobility disability. Subjects will begin the task standing between the 2 cones. The subject will walk a figure 8 course 3 times for each condition at their self-selected pace and stop when they return to the start position. The outcomes of the test are the time to complete the course.
Outcome measures
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Figure-of-8 Walking Test: Time
|
-0.53 seconds
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: Daily for 2-4 weeksPopulation: All participants with a recorded score for both investigational and usual foot were included.
Difference between investigational foot and usual foot of the average daily values of the visual analog scale of participant's perception of gait on challenging surface. Scale range: 0-100 Values: 0 = worst outcome; 100 = best outcome
Outcome measures
| Measure |
Lower Extremity Amputees
n=29 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Daily Activity Log: Scale Measuring How Prosthesis Helps or Hinders When Walking on a Challenging Surface
|
10.5 score on a scale
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.Population: All
Self-report questionnaire. PEQ Subscales: The PEQ is a 9-scale instrument that has good psychometric properties and has been validated. The PEQ subscales have a range from 0 (worst) to 100 (best). PEQ subscales of residual limb health, ambulation, utility, and sounds were selected for this study and comprise a total of 24 visual analogue scale questions. ICC estimates for these subscales for the first and second administration ranged from 0.79 to 0.9.
Outcome measures
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Residual Limb Health Subscale
|
1.6 score on a scale
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.Population: All
The intent of the CLASS Stability Subscale is to provide greater insight into the cause of socket dissatisfaction compared to the Socket Comfort Score. This subcategory of the CLASS contains 4 items scored using a 5-point scale that relate to common tasks such as standing, sitting, walking, and ascending and descending stairs. Values: 0 = worst outcome; 16 = best outcome
Outcome measures
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Stability Subscale
|
3.2 score on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline (A1), after 2-week trial of investigational foot (B). Primary analysis uses B minus A1.Population: All
The Narrowing Beam Walking Test was developed to measure balance in lower extremity amputees (LEA) and it was validated in LEPU with and without a history of falls. The test consists of walking across a beam that has 4, 6-foot long sections, each one more narrow than the previous one. The narrowing beam is 2" above the floor. Subjects must keep their arms crossed in front of their body to eliminate the use of their arms to maintain balance. The distance of the furthest point of contact from the start of the beam is used as the outcome for the test.
Outcome measures
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Narrowing Beam Walking Test: Distance Travelled
|
0.45 feet
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Average of daily measurements for 2-4 weeks using the investigational foot (B) and 2-4 weeks using the usual foot (A2). Outcome is B- A2.Population: All
Difference between investigational foot and usual foot of the average daily values of the visual analog scale of participant's perception of balance confidence. Scale range: 0-100 Values: 0 = worst outcome; 100 = best outcome
Outcome measures
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Daily Activity Log: Balance Confidence
|
-0.2 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.Population: All
Self-report questionnaire. PEQ Subscales: The PEQ is a 9-scale instrument that has good psychometric properties and has been validated. The PEQ subscales have a range from 0 (worst) to 100 (best). PEQ subscales of residual limb health, ambulation, utility, and sounds were selected for this study and comprise a total of 24 visual analogue scale questions. ICC estimates for these subscales for the first and second administration ranged from 0.79 to 0.9.
Outcome measures
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Utility Subscale
|
4.2 score on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.Population: All
Self-report questionnaire. PEQ Subscales: The PEQ is a 9-scale instrument that has good psychometric properties and has been validated. The PEQ subscales have a range from 0 (worst) to 100 (best). PEQ subscales of residual limb health, ambulation, utility, and sounds were selected for this study and comprise a total of 24 visual analogue scale questions. ICC estimates for these subscales for the first and second administration ranged from 0.79 to 0.9.
Outcome measures
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Sound Subscale
|
-8.9 score on a scale
Standard Deviation 30.2
|
SECONDARY outcome
Timeframe: Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.Population: All
The intent of the CLASS Suspension is to provide greater insight into the cause of socket dissatisfaction compared to the Socket Comfort Score. This subcategory contains 4 items scored using a 5-point scale that relate to common tasks such as standing, sitting, walking, and ascending and descending stairs. Scale range: 0-16 Values: 0 = worst outcome; 16 = best outcome
Outcome measures
| Measure |
Lower Extremity Amputees
n=31 Participants
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Suspension Subscales
|
0.2 score on a scale
Standard Deviation 11.8
|
Adverse Events
Lower Extremity Amputees
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lower Extremity Amputees
n=31 participants at risk
Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.
Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
|
|---|---|
|
General disorders
falls - usual foot condition A2
|
9.7%
3/31 • Number of events 3 • 4-8 weeks per individual participant
|
|
General disorders
falls - investigational foot condition B
|
9.7%
3/31 • Number of events 5 • 4-8 weeks per individual participant
|
|
Musculoskeletal and connective tissue disorders
Residual limb pain usual foot condition A2
|
0.00%
0/31 • 4-8 weeks per individual participant
|
|
Musculoskeletal and connective tissue disorders
Residual limb pain investigational foot condition B
|
3.2%
1/31 • Number of events 1 • 4-8 weeks per individual participant
|
Additional Information
Murray Maitland PT, PhD, Associate Professor
University of Washington
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place