Trial Outcomes & Findings for Prosthetic Components and Stability in Amputee Gait (NCT NCT00167778)
NCT ID: NCT00167778
Last Updated: 2014-08-15
Results Overview
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
COMPLETED
NA
12 participants
Measurements were taken after wearing the study prostheses for three weeks.
2014-08-15
Participant Flow
Recruitment for this study was conducted at the VA Puget Sound Health Care System (Seattle VA hospital). Recruitment began on May 18, 2006. The study was closed to enrollment on April 24, 2008. Data was not collected on the order in which participants received each study intervention.
The prostheses used in this study were built and aligned by a certified and licensed prosthetist prior to beginning starting the protocol. 12 individuals provided informed consent. 1 withdrew prior to starting for personal reasons. 1 withdrew due to unrelated back pain after being fit with both study prostheses and starting with the rigid pylon.
Participant milestones
| Measure |
Amputee
This is a randomized cross-over study. Each participant wore both study prostheses: (1) a rigid pylon and (2) a transverse plane torsion adapter. The torsion adapter was initially set according to the manufacturer's recommendations based on body mass and activity level. After one week of acclimation, additional stiffness adjustments were made based on participant feedback. This process continued until the perceived stiffness was optimized. All participants were able to find a comfortable fit either on the first or second visit. Subjects were then randomized, provided with one of two study prostheses, and asked to wear it for 3 weeks. Data was then collected during lab visit 1, and following 1 more week, additional data was collected during lab visit 2. Subjects were then provided with the second study prosthesis and asked to wear it for 3 weeks. Data was then collected during lab visit 3, and following 1 more week, additional data was collected during lab visit 4.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Amputee
This is a randomized cross-over study. Each participant wore both study prostheses: (1) a rigid pylon and (2) a transverse plane torsion adapter. The torsion adapter was initially set according to the manufacturer's recommendations based on body mass and activity level. After one week of acclimation, additional stiffness adjustments were made based on participant feedback. This process continued until the perceived stiffness was optimized. All participants were able to find a comfortable fit either on the first or second visit. Subjects were then randomized, provided with one of two study prostheses, and asked to wear it for 3 weeks. Data was then collected during lab visit 1, and following 1 more week, additional data was collected during lab visit 2. Subjects were then provided with the second study prosthesis and asked to wear it for 3 weeks. Data was then collected during lab visit 3, and following 1 more week, additional data was collected during lab visit 4.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Prosthetic Components and Stability in Amputee Gait
Baseline characteristics by cohort
| Measure |
Amputee
n=10 Participants
Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 12 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Amputation Etiology
Trauma
|
5 participants
n=99 Participants
|
|
Amputation Etiology
Diabetic/Dysvascular
|
4 participants
n=99 Participants
|
|
Amputation Etiology
Tumor
|
1 participants
n=99 Participants
|
|
Torsion adapter stiffness
|
4 units on a scale
STANDARD_DEVIATION 2 • n=99 Participants
|
|
Weight
|
88 kg
STANDARD_DEVIATION 11 • n=99 Participants
|
|
Height
|
1.79 m
STANDARD_DEVIATION .08 • n=99 Participants
|
PRIMARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Local Dynamic Stability (Hip During Straight Walking)
|
.74 dimensionless
Standard Deviation .12
|
.74 dimensionless
Standard Deviation .13
|
PRIMARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Local Dynamic Stability (Knee During Straight Walking)
|
1.00 dimensionless
Standard Deviation .21
|
1.16 dimensionless
Standard Deviation .30
|
PRIMARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Local Dynamic Stability (Ankle During Straight Walking)
|
.81 dimensionless
Standard Deviation .23
|
.96 dimensionless
Standard Deviation .28
|
PRIMARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Local Dynamic Stability (Hip During Turning With the Prosthesis on the Inside of the Turn)
|
.85 dimensionless
Standard Deviation .11
|
.83 dimensionless
Standard Deviation .14
|
PRIMARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Local Dynamic Stability (Knee During Turning With the Prosthesis on the Inside of the Turn)
|
1.20 dimensionless
Standard Deviation .30
|
1.20 dimensionless
Standard Deviation .25
|
PRIMARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Inside of the Turn)
|
.96 dimensionless
Standard Deviation .22
|
.87 dimensionless
Standard Deviation .27
|
PRIMARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Local Dynamic Stability (Hip During Turning With the Prosthesis on the Outside of the Turn)
|
.75 dimensionless
Standard Deviation .10
|
.74 dimensionless
Standard Deviation .11
|
PRIMARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Local Dynamic Stability (Knee During Turning With the Prosthesis on the Outside of the Turn)
|
1.16 dimensionless
Standard Deviation .18
|
1.12 dimensionless
Standard Deviation .29
|
PRIMARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee's sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Outside of the Turn)
|
.84 dimensionless
Standard Deviation .33
|
.96 dimensionless
Standard Deviation .21
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Peak External Rotation Moment of the Outside Hip While Turning
|
-70 N*mm/kg
Standard Deviation 54
|
-88 N*mm/kg
Standard Deviation 45
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Peak External Rotation Moment of the Outside Knee While Turning
|
-7 N*mm/kg
Standard Deviation 21
|
-15 N*mm/kg
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Peak External Rotation Moment of the Outside Ankle While Turning
|
-28 N*mm/kg
Standard Deviation 31
|
-42 N*mm/kg
Standard Deviation 33
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Peak External Rotation Moment of the Inside Hip While Turning
|
-54 N*mm/kg
Standard Deviation 47
|
-57 N*mm/kg
Standard Deviation 45
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Peak External Rotation Moment of the Inside Knee While Turning
|
-26 N*mm/kg
Standard Deviation 27
|
-24 N*mm/kg
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for three weeks.Population: Each participant wore both study prostheses.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Peak External Rotation Moment of the Inside Ankle While Turning
|
-36 N*mm/kg
Standard Deviation 48
|
-25 N*mm/kg
Standard Deviation 16
|
SECONDARY outcome
Timeframe: One weekPopulation: Each participant wore both study prostheses.
Average number of steps per day over a 1 week period ending in the fourth week of each study prosthesis (Rigid and Torsion adapter)
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Activity Level
|
6269 Steps/day
Standard Error 1080
|
6728 Steps/day
Standard Error 1121
|
SECONDARY outcome
Timeframe: Six minutes after wearing the study prostheses for four weeks.Population: Each participant wore both study prostheses.
Participants are asked to walk alone as far as possible without running for six minutes. This test is performed indoors along a long, flat straight hallway of approximately 30 meters in length with two orange cones marking the 180 degree turnaround points at each end of the corridor. Approximately 40 straight steps were taken for every four turning steps.
Outcome measures
| Measure |
Rigid Pylon
n=10 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=10 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Six-minute Walk Distance
|
463 m
Standard Error 24
|
464 m
Standard Error 26
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for four weeksPopulation: 10 participants wore both study prostheses but only 7 participants presented with pain.
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Outcome measures
| Measure |
Rigid Pylon
n=7 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=7 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Residual Limb Pain at Present?
|
2.0 units on a scale
Standard Error 0.7
|
1.6 units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for four weeks.Population: 10 participants wore both study prostheses but only 7 participants presented with pain.
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Outcome measures
| Measure |
Rigid Pylon
n=7 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=7 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Average Residual Limb Pain?
|
2.9 units on a scale
Standard Error 0.5
|
2.3 units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for four weeks.Population: 10 participants wore both study prostheses but only 7 participants presented with pain.
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Outcome measures
| Measure |
Rigid Pylon
n=7 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=7 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Worst Residual Limb Pain?
|
4.7 units on a scale
Standard Error 1.0
|
3.6 units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for four weeks.Population: 10 participants wore both study prostheses but only 7 participants presented with pain.
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Outcome measures
| Measure |
Rigid Pylon
n=7 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=7 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Least Residual Limb Pain?
|
1.9 units on a scale
Standard Error 0.6
|
1.6 units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for four weeks.Population: 10 participants wore both study prostheses but only 7 participants presented with pain.
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Outcome measures
| Measure |
Rigid Pylon
n=7 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=7 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
Pain Interference With Activities?
|
3.4 units on a scale
Standard Error 0.8
|
1.6 units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Measurements were taken after wearing the study prostheses for four weeks.Population: 10 participants wore both study prostheses but only 7 participants presented with pain.
The residual limb pain grade scores ranged from 0 "No Pain/ Interference" to 10 "Severe Pain/Interference."
Outcome measures
| Measure |
Rigid Pylon
n=7 Participants
A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
|
Torsion Adapter Pylon
n=7 Participants
A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
|
|---|---|---|
|
How Bothersome Was Your Pain?
|
3.1 units on a scale
Standard Error 1.1
|
2.9 units on a scale
Standard Error 1.1
|
Adverse Events
Amputee
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Glenn K. Klute, PhD
Dept. of Veterans Affairs, Rehabilitation Research & Development Service
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place