Trial Outcomes & Findings for Evaluation of a Modified Running-specific Prosthetic Foot (NCT NCT02440711)
NCT ID: NCT02440711
Last Updated: 2023-08-02
Results Overview
Breath-by-Breath VO2 was collected as participants walked on a treadmill at self selected fast, normal, and slow speeds. Participants walked for 6 minutes at each speed (and in each experimental condition). VO2 was normalized energy expenditure to each participant's biological mass (i.e., body mass without prosthesis) Normalized VO2 data were averaged to produce 30-s values for minutes 3-6 of each trial. These 30-s values were used in for the described analyses. Both gross and net VO2 were examined, but produced similar results, so only gross VO2 results are reported.
COMPLETED
NA
36 participants
Participants were tested after using each foot in their prosthesis for 1 month.
2023-08-02
Participant Flow
39 participants were screened for eligibility between May 15, 2015 and 09/26/2017 at a research laboratory in Seattle, WA.
39 participants were randomized. 3 participants did not meet the eligibility criteria. 36 participants were enrolled.
Participant milestones
| Measure |
mRSF-ESF
Study participants in Arm 1 will first receive the Modified running specific foot (mRSF) and then the Energy storing foot (ESF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned.
Energy storing foot (ESF): A commercially-available energy storing prosthetic foot
Modified running specific foot (mRSF): A running specific prosthetic foot customized for both running and walking activities
|
ESF-mRSF
Study participants in Arm 2 will first receive the Energy storing foot (ESF) and then the Modified running specific foot (mRSF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned.
Energy storing foot (ESF): A commercially-available energy storing prosthetic foot
Modified running specific foot (mRSF): A running specific prosthetic foot customized for both running and walking activities
|
|---|---|---|
|
First Intervention
STARTED
|
16
|
20
|
|
First Intervention
Unilateral Amputation
|
14
|
17
|
|
First Intervention
Bilateral Amputation
|
2
|
3
|
|
First Intervention
COMPLETED
|
16
|
20
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
16
|
20
|
|
Second Intervention
Unilateral Amputation
|
14
|
17
|
|
Second Intervention
Bilateral Amputation
|
2
|
3
|
|
Second Intervention
COMPLETED
|
15
|
20
|
|
Second Intervention
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
mRSF-ESF
Study participants in Arm 1 will first receive the Modified running specific foot (mRSF) and then the Energy storing foot (ESF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned.
Energy storing foot (ESF): A commercially-available energy storing prosthetic foot
Modified running specific foot (mRSF): A running specific prosthetic foot customized for both running and walking activities
|
ESF-mRSF
Study participants in Arm 2 will first receive the Energy storing foot (ESF) and then the Modified running specific foot (mRSF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned.
Energy storing foot (ESF): A commercially-available energy storing prosthetic foot
Modified running specific foot (mRSF): A running specific prosthetic foot customized for both running and walking activities
|
|---|---|---|
|
Second Intervention
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Evaluation of a Modified Running-specific Prosthetic Foot
Baseline characteristics by cohort
| Measure |
mRSF-ESF
n=16 Participants
Study participants in Arm 1 will first receive the Modified running specific foot (mRSF) and then the Energy storing foot (ESF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned.
Energy storing foot (ESF): A commercially-available energy storing prosthetic foot
Modified running specific foot (mRSF): A running specific prosthetic foot customized for both running and walking activities
|
ESF-mRSF
n=20 Participants
Study participants in Arm 2 will first receive the Energy storing foot (ESF) and then the Modified running specific foot (mRSF). Outcomes will be assessed (in each condition) after 1 month of use. Order of interventions will be randomly assigned.
Energy storing foot (ESF): A commercially-available energy storing prosthetic foot
Modified running specific foot (mRSF): A running specific prosthetic foot customized for both running and walking activities
|
Total
n=36 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
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
44.0 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
20 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Height
|
180.9 centimeters
STANDARD_DEVIATION 8.6 • n=5 Participants
|
176.6 centimeters
STANDARD_DEVIATION 10.3 • n=7 Participants
|
178.5 centimeters
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Weight
|
82.5 kilograms
STANDARD_DEVIATION 12.7 • n=5 Participants
|
85.9 kilograms
STANDARD_DEVIATION 22.3 • n=7 Participants
|
84.4 kilograms
STANDARD_DEVIATION 18.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
Breath-by-Breath VO2 was collected as participants walked on a treadmill at self selected fast, normal, and slow speeds. Participants walked for 6 minutes at each speed (and in each experimental condition). VO2 was normalized energy expenditure to each participant's biological mass (i.e., body mass without prosthesis) Normalized VO2 data were averaged to produce 30-s values for minutes 3-6 of each trial. These 30-s values were used in for the described analyses. Both gross and net VO2 were examined, but produced similar results, so only gross VO2 results are reported.
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Metabolic Oxygen Consumption (VO2), Participants With Unilateral Amputation
VO2 - slow walking speed
|
1041.1 ml/min
Standard Deviation 246.1
|
1077.4 ml/min
Standard Deviation 245.2
|
|
Metabolic Oxygen Consumption (VO2), Participants With Unilateral Amputation
VO2 - comfortable walking speed
|
1210.9 ml/min
Standard Deviation 280.9
|
1253.5 ml/min
Standard Deviation 276.3
|
|
Metabolic Oxygen Consumption (VO2), Participants With Unilateral Amputation
VO2 - fast walking speed
|
1509.6 ml/min
Standard Deviation 398.8
|
1565.1 ml/min
Standard Deviation 376.4
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
Breath-by-Breath VO2 was collected as participants walked on a treadmill at self selected fast, normal, and slow speeds. Participants walked for 6 minutes at each speed (and in each experimental condition). VO2 was normalized energy expenditure to each participant's biological mass (i.e., body mass without prosthesis) Normalized VO2 data were averaged to produce 30-s values for minutes 3-6 of each trial. These 30-s values were used in for the described analyses. Both gross and net VO2 were examined, but produced similar results, so only gross VO2 results are reported.
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Metabolic Oxygen Consumption (VO2), Participants With Bilateral Amputation
VO2 - slow walking speed
|
779.6 ml/min
Standard Deviation 299.2
|
867.3 ml/min
Standard Deviation 397.7
|
|
Metabolic Oxygen Consumption (VO2), Participants With Bilateral Amputation
VO2 - comfortable walking speed
|
889.9 ml/min
Standard Deviation 300.8
|
985.0 ml/min
Standard Deviation 413.4
|
|
Metabolic Oxygen Consumption (VO2), Participants With Bilateral Amputation
VO2 - fast walking speed
|
1081.9 ml/min
Standard Deviation 319.0
|
1162.8 ml/min
Standard Deviation 439.3
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
Participants were asked to walk as far as possible in 6 minutes. Participants walked around cones placed 30m apart in a level hallway. Total distance (in meters) walked in 6 minutes was recorded.
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Six-minute Walk Test (6MWT), Participants With Unilateral Amputation
|
543.3 meters
Standard Deviation 92.6
|
537.1 meters
Standard Deviation 100.8
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
Participants were asked to walk as far as possible in 6 minutes. Participants walked around cones placed 30m apart in a level hallway. Total distance (in meters) walked in 6 minutes was recorded.
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Six-minute Walk Test (6MWT), Participants With Bilateral Amputation
|
441.1 meters
Standard Deviation 72.7
|
448.9 meters
Standard Deviation 77.5
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
Participants were asked to self-report their level of perceived exertion after completing the 6MWT. Participants were shown the Borg CR100 rating scale and asked to identify their level of exertion on a scale ranging from 0 to 120. Higher scores mean greater exertion.
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Borg Rating of Perceived Exertion (CR100), Participants With Unilateral Amputation
|
36.4 units on a scale
Standard Deviation 31.4
|
47.3 units on a scale
Standard Deviation 28.0
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
Participants were asked to self-report their level of perceived exertion after completing the 6MWT. Participants were shown the Borg CR100 rating scale and asked to identify their level of exertion on a scale ranging from 0 to 120. Higher scores mean greater exertion.
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Borg Rating of Perceived Exertion (CR100), Participants With Bilateral Amputation
|
30.4 units on a scale
Standard Deviation 21.7
|
35.6 units on a scale
Standard Deviation 19.2
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
Walking speed (m/s) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Walking Speed, Participants With Unilateral Amputation
|
1.62 meters / second
Standard Deviation 0.29
|
1.60 meters / second
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
Walking speed (m/s) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Walking Speed, Participants With Bilateral Amputation
|
1.35 meters / second
Standard Deviation 0.23
|
1.35 meters / second
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
Step width was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Step Width, Participants With Unilateral Amputation
|
13.7 centimeters
Standard Deviation 3.8
|
13.7 centimeters
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
Step width was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT).
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Step Width, Participants With Bilateral Amputation
|
16.9 centimeters
Standard Deviation 5.4
|
16.7 centimeters
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
Step length (cm) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step length is reported for both the prosthetic and sound (intact) limbs.
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Step Length, Participants With Unilateral Amputation
Prosthetic side
|
78.8 centimeters
Standard Deviation 9.2
|
79.4 centimeters
Standard Deviation 9.4
|
|
Step Length, Participants With Unilateral Amputation
Sound side
|
79.5 centimeters
Standard Deviation 10.2
|
76.5 centimeters
Standard Deviation 9.8
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
Step length (cm) was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step length is reported for both the prosthetic and sound (intact) limbs.
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Step Length, Participants With Bilateral Amputation
Left side
|
0.69 centimeters
Standard Deviation 0.08
|
0.68 centimeters
Standard Deviation 0.13
|
|
Step Length, Participants With Bilateral Amputation
Right side
|
0.69 centimeters
Standard Deviation 0.11
|
0.69 centimeters
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
Step time was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step time is reported for both the prosthetic and sound (intact) limbs.
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Step Time, Participants With Unilateral Amputation
Prosthetic side
|
0.49 seconds
Standard Deviation 0.05
|
0.49 seconds
Standard Deviation 0.05
|
|
Step Time, Participants With Unilateral Amputation
Sound side
|
0.50 seconds
Standard Deviation 0.05
|
0.50 seconds
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
Step time was assessed with a 16-foot CIR GAITRite instrumented walkway while participants performed the 6-minute walk test (6MWT). Step time is reported for both the prosthetic and sound (intact) limbs.
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Step Time, Participants With Bilateral Amputation
Right side
|
0.53 seconds
Standard Deviation 0.05
|
0.52 seconds
Standard Deviation 0.04
|
|
Step Time, Participants With Bilateral Amputation
Left side
|
0.51 seconds
Standard Deviation 0.04
|
0.51 seconds
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Participants' step count data from the 2 weeks prior to in-person testing.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
Daily step activity (steps / day) were measured over the 2-week period prior to assessment using a Orthocare Innovations Stepwatch 3 activity monitor.
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Daily Step Activity, Participants With Unilateral Amputation
|
4109 steps per day
Standard Deviation 1517
|
4307 steps per day
Standard Deviation 1750
|
SECONDARY outcome
Timeframe: Participants' step count data from the 2 weeks prior to in-person testing.Population: Data are from participants with bilateral amputation.
Daily step activity (steps / day) were measured over the 2-week period prior to assessment using a Orthocare Innovations Stepwatch 3 activity monitor.
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Daily Step Activity, Participants With Bilateral Amputation
|
2464 steps per day
Standard Deviation 455
|
3007 steps per day
Standard Deviation 617
|
SECONDARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
The PLUS-M is a self-report instrument designed to evaluate respondent's prosthetic mobility. It is scored using a standardized T-score centered on a national sample of unilateral lower limb prosthesis users (mean = 50, standard deviation = 10). Participants were administered the PLUS-M computerized adaptive test and 12-item form on an iPad tablet. The most precise score (i.e., score with the lowest error) was used for analysis. Absolute score range from 0 to 100. Higher T-scores indicate greater mobility.
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Prosthetic Limb Users Survey of Mobility (PLUS-M), Participants With Unilateral Amputation
|
64.2 T-score
Standard Deviation 7.7
|
59.3 T-score
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
The PLUS-M is a self-report instrument designed to evaluate respondent's prosthetic mobility. It is scored using a standardized T-score centered on a national sample of unilateral lower limb prosthesis users (mean = 50, standard deviation = 10). Participants were administered the PLUS-M computerized adaptive test and 12-item form on an iPad tablet. The most precise score (i.e., score with the lowest error) was used for analysis. Absolute score range from 0 to 100. Higher T-scores indicate greater mobility.
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Prosthetic Limb Users Survey of Mobility (PLUS-M), Participants With Bilateral Amputation
|
59.3 T-score
Standard Deviation 3.8
|
54.8 T-score
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
The PROMIS-Fatigue is a self-report instrument designed to evaluate respondent's symptoms and effects of fatigue. It is scored using a standardized T-score centered on the US general population (mean = 50, standard deviation = 10). Participants were administered the computerized adaptive test and a 12-item short form on an iPad tablet. The most precise score (i.e., score with the lowest error) was used for analysis. Absolute score range from 0 to 100. Higher T-scores indicate greater fatigue.
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Patient Reported Outcome Measurement Information System - Fatigue (PROMIS-Fatigue), Participants With Unilateral Amputation
|
45.4 T-score
Standard Deviation 7.5
|
49.1 T-score
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
The PROMIS-Fatigue is a self-report instrument designed to evaluate respondent's symptoms and effects of fatigue. It is scored using a standardized T-score centered on the US general population (mean = 50, standard deviation = 10). Participants were administered the computerized adaptive test and a 12-item short form on an iPad tablet. The most precise score (i.e., score with the lowest error) was used for analysis. Absolute score range from 0 to 100. Higher T-scores indicate greater fatigue.
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Patient Reported Outcome Measurement Information System - Fatigue (PROMIS-Fatigue), Participants With Bilateral Amputation
|
42.1 T-score
Standard Deviation 8.9
|
47.7 T-score
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
The ABC is a self-report instrument designed to evaluate respondent's confidence in performing normal daily activities. It is scored from 0 to 4. Participants were administered an electronic version of the ABC on an iPad tablet. Scores range from 0 to 4. Higher scores indicate greater balance confidence.
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Activities-Specific Balance Confidence Scale (ABC), Participants With Unilateral Amputation
|
3.5 score on a scale
Standard Deviation 0.4
|
3.2 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
The ABC is a self-report instrument designed to evaluate respondent's confidence in performing normal daily activities. It is scored from 0 to 4. Participants were administered an electronic version of the ABC on an iPad tablet. Scores range from 0 to 4. Higher scores indicate greater balance confidence.
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Activities-Specific Balance Confidence Scale (ABC), Participants With Bilateral Amputation
|
3.4 score on a scale
Standard Deviation 0.3
|
3.0 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from 27 participants with unilateral amputation. Data from 1 participant who did not complete the protocol and 3 participants who experienced serious life events unrelated to the study that disproportionately affected one phase of the study were not analyzed.
The TAPES-R is a self-report instrument designed to evaluate respondent's activity restrictions and satisfaction with a prosthesis. The TAPES-R has three subscales (activity restrictions \[TAPES-AR\], functional satisfaction \[TAPES-FUN\], and aesthetic satisfaction \[TAPES-AES\], each scored from 0 to 2. Higher scores indicate more activity restrictions (TAPES-AR) or greater satisfaction (TAPES-FUN and TAPES-AES). Participants were administered an electronic version of the TAPES-R on an iPad tablet.
Outcome measures
| Measure |
mRSF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=27 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Unilateral Amputation
TAPES-AR
|
0.4 score on a scale
Standard Deviation 0.3
|
0.6 score on a scale
Standard Deviation 0.4
|
|
Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Unilateral Amputation
TAPES-FUN
|
1.8 score on a scale
Standard Deviation 0.4
|
1.3 score on a scale
Standard Deviation 0.5
|
|
Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Unilateral Amputation
TAPES-AES
|
1.5 score on a scale
Standard Deviation 0.5
|
1.5 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Participants were tested after using each foot in their prosthesis for 1 month.Population: Data are from participants with bilateral amputation.
The TAPES-R is a self-report instrument designed to evaluate respondent's activity restrictions and satisfaction with a prosthesis. The TAPES-R has three subscales (activity restrictions \[TAPES-AR\], functional satisfaction \[TAPES-FUN\], and aesthetic satisfaction \[TAPES-AES\], each scored from 0 to 2. Higher scores indicate more activity restrictions (TAPES-AR) or greater satisfaction (TAPES-FUN and TAPES-AES). Participants were administered an electronic version of the TAPES-R on an iPad tablet.
Outcome measures
| Measure |
mRSF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the mRSF.
|
ESF (Unilateral)
n=5 Participants
Participants with unilateral amputation tested while wearing the ESF.
|
|---|---|---|
|
Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Bilateral Amputation
TAPES-AR
|
0.7 score on a scale
Standard Deviation 0.2
|
0.9 score on a scale
Standard Deviation 0.2
|
|
Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Bilateral Amputation
TAPES-FUN
|
1.8 score on a scale
Standard Deviation 0.4
|
1.1 score on a scale
Standard Deviation 0.2
|
|
Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Bilateral Amputation
TAPES-AES
|
1.8 score on a scale
Standard Deviation 0.3
|
0.9 score on a scale
Standard Deviation 0.5
|
Adverse Events
mRSF (Unilateral and Bilateral)
ESF (Unilateral and Bilateral)
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