Trial Outcomes & Findings for Lower Limb Prostheses for Individuals Who Carry Infants, Toddlers, and Other Loads (NCT NCT07159490)
NCT ID: NCT07159490
Last Updated: 2026-02-12
Results Overview
A measure of body support. Normalized by body mass, including the mass of the load when applicable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
During study visit (approximately 3 hours)
Results posted on
2026-02-12
Participant Flow
One enrolled participant decided they were no longer interested in participating after the first visit (alignment and acclimation) but before the second visit (randomization).
Participant milestones
| Measure |
Individuals With Lower Limb Amputation
In this cross-over study, all subjects were asked to with no added load and four added load conditions using a weighted pack (13.6 kg or \~30 lbs) to simulate an infant, toddler, or other load. The four conditions include the pack strapped to their front (anterior), their back (posterior), and carried with their arms on the intact limb side and the prosthetic limb side. The load conditions were presented in block randomized order.
While performing each of these activities, the participant wore five different prosthetic feet. These prosthetic feet included a standard-of-care prosthetic foot, this same prosthetic foot with a heel-stiffening wedge, this same prosthetic foot but one category stiffer, a dual keel prosthetic foot intended for load carriage applications, and a powered ankle-foot purported to adapt to changing loads. The prosthetic feet were worn in randomized order and the subject was blinded to the study foot using a sock and foot cover when possible (wearing a powered ankle-foot is obvious to the participant).
The study was conducted over two visits with overnight rest in between each visit. During the first study visit, each study foot was aligned to the participant's prosthesis and wore each for at least 15 minutes. During the second study visit, the participant walked wearing each of the five different study feet while performing each of the five different load conditions.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
**Standard-of-care prosthetic foot
|
12
|
|
Overall Study
Walking with no added load
|
7
|
|
Overall Study
Walking with anterior load
|
7
|
|
Overall Study
Walking with posterior side
|
12
|
|
Overall Study
Walking with load on prosthetic side
|
7
|
|
Overall Study
Walking with load on intact side
|
7
|
|
Overall Study
**Standard-of-care prosthetic foot of one category greater stiffness
|
12
|
|
Overall Study
Walking with posterior load
|
7
|
|
Overall Study
**Standard-of-care prosthetic foot with heel-stiffening wedge
|
12
|
|
Overall Study
**Dual keel prosthetic foot
|
12
|
|
Overall Study
**Powered ankle-foot
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lower Limb Prostheses for Individuals Who Carry Infants, Toddlers, and Other Loads
Baseline characteristics by cohort
| Measure |
Individuals With Lower Limb Amputation
n=12 Participants
In this cross-over study, all subjects were asked to with no added load and four added load conditions using a weighted pack (13.6 kg or \~30 lbs) to simulate an infant, toddler, or other load. The four conditions include the pack strapped to their front (anterior), their back (posterior), and carried with their arms on the intact limb side and the prosthetic limb side. The load conditions were presented in block randomized order.
While performing each of these activities, the participant wore five different prosthetic feet. These prosthetic feet included a standard-of-care prosthetic foot, this same prosthetic foot with a heel-stiffening wedge, this same prosthetic foot but one category stiffer, a dual keel prosthetic foot intended for load carriage applications, and a powered ankle-foot purported to adapt to changing loads. The prosthetic feet were worn in randomized order and the subject was blinded to the study foot using a sock and foot cover when possible (wearing a powered ankle-foot is obvious to the participant).
The study was conducted over two visits with overnight rest in between each visit. During the first study visit, each study foot was aligned to the participant's prosthesis and wore each for at least 15 minutes. During the second study visit, the participant walked wearing each of the five different study feet while performing each of the five different load conditions.
|
|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 15 • n=47 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=47 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=47 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=47 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=47 Participants
|
PRIMARY outcome
Timeframe: During study visit (approximately 3 hours)A measure of body support. Normalized by body mass, including the mass of the load when applicable.
Outcome measures
| Measure |
Standard-of-care Prosthetic Foot
n=12 Participants
Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.
|
Standard-of-care Prosthetic Foot With Heel-stiffening Wedge
n=12 Participants
Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.
|
Standard-of-care Prosthetic Foot of One Category Greater Stiffness
n=12 Participants
Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.
|
Dual Keel Prosthetic Foot
n=12 Participants
A prosthetic foot with two forefoot keels intended for load carriage applications.
|
Powered Ankle-foot
n=7 Participants
A powered prosthetic ankle-foot.
|
|---|---|---|---|---|---|
|
Vertical Ground Reaction Force Impulse (Normalized)
Walking with load on intact side
|
5.25 Newtons*seconds/kg
Standard Error .14
|
5.24 Newtons*seconds/kg
Standard Error .14
|
5.14 Newtons*seconds/kg
Standard Error .14
|
5.21 Newtons*seconds/kg
Standard Error .14
|
5.35 Newtons*seconds/kg
Standard Error .15
|
|
Vertical Ground Reaction Force Impulse (Normalized)
Walking with no added load
|
5.24 Newtons*seconds/kg
Standard Error .14
|
5.30 Newtons*seconds/kg
Standard Error .14
|
5.27 Newtons*seconds/kg
Standard Error .14
|
5.33 Newtons*seconds/kg
Standard Error .14
|
5.46 Newtons*seconds/kg
Standard Error .15
|
|
Vertical Ground Reaction Force Impulse (Normalized)
Walking with posterior load
|
5.37 Newtons*seconds/kg
Standard Error .14
|
5.40 Newtons*seconds/kg
Standard Error .14
|
5.42 Newtons*seconds/kg
Standard Error .14
|
5.39 Newtons*seconds/kg
Standard Error .14
|
5.63 Newtons*seconds/kg
Standard Error .15
|
|
Vertical Ground Reaction Force Impulse (Normalized)
Walking with anterior load
|
5.24 Newtons*seconds/kg
Standard Error .14
|
5.26 Newtons*seconds/kg
Standard Error .14
|
5.29 Newtons*seconds/kg
Standard Error .14
|
5.28 Newtons*seconds/kg
Standard Error .14
|
5.44 Newtons*seconds/kg
Standard Error .15
|
|
Vertical Ground Reaction Force Impulse (Normalized)
Walking with load on prosthetic side
|
5.29 Newtons*seconds/kg
Standard Error .14
|
5.29 Newtons*seconds/kg
Standard Error .14
|
5.24 Newtons*seconds/kg
Standard Error .14
|
5.34 Newtons*seconds/kg
Standard Error .14
|
5.51 Newtons*seconds/kg
Standard Error .15
|
PRIMARY outcome
Timeframe: During study visit (approximately 3 hours)A measure of body forward propulsion. Normalized by body mass, including the mass of the load when applicable.
Outcome measures
| Measure |
Standard-of-care Prosthetic Foot
n=12 Participants
Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.
|
Standard-of-care Prosthetic Foot With Heel-stiffening Wedge
n=12 Participants
Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.
|
Standard-of-care Prosthetic Foot of One Category Greater Stiffness
n=12 Participants
Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.
|
Dual Keel Prosthetic Foot
n=12 Participants
A prosthetic foot with two forefoot keels intended for load carriage applications.
|
Powered Ankle-foot
n=7 Participants
A powered prosthetic ankle-foot.
|
|---|---|---|---|---|---|
|
Anterior Ground Reaction Force Impulse (Normalized)
Walking with no added load
|
0.232 Newtons*seconds/kg
Standard Error .014
|
0.228 Newtons*seconds/kg
Standard Error .014
|
0.213 Newtons*seconds/kg
Standard Error .014
|
0.214 Newtons*seconds/kg
Standard Error .014
|
.257 Newtons*seconds/kg
Standard Error .017
|
|
Anterior Ground Reaction Force Impulse (Normalized)
Walking with posterior load
|
0.236 Newtons*seconds/kg
Standard Error .014
|
0.236 Newtons*seconds/kg
Standard Error .014
|
0.219 Newtons*seconds/kg
Standard Error .014
|
.225 Newtons*seconds/kg
Standard Error .014
|
0.257 Newtons*seconds/kg
Standard Error .018
|
|
Anterior Ground Reaction Force Impulse (Normalized)
Walking with anterior load
|
0.225 Newtons*seconds/kg
Standard Error .014
|
0.235 Newtons*seconds/kg
Standard Error 0.014
|
0.212 Newtons*seconds/kg
Standard Error .014
|
0.217 Newtons*seconds/kg
Standard Error .014
|
0.248 Newtons*seconds/kg
Standard Error .017
|
|
Anterior Ground Reaction Force Impulse (Normalized)
Walking with prosthetic side load
|
0.219 Newtons*seconds/kg
Standard Error .014
|
0.223 Newtons*seconds/kg
Standard Error .014
|
0.213 Newtons*seconds/kg
Standard Error .014
|
0.214 Newtons*seconds/kg
Standard Error 0.014
|
0.256 Newtons*seconds/kg
Standard Error .018
|
|
Anterior Ground Reaction Force Impulse (Normalized)
Walking with intact side load
|
0.224 Newtons*seconds/kg
Standard Error .014
|
0.219 Newtons*seconds/kg
Standard Error 0.014
|
0.210 Newtons*seconds/kg
Standard Error .014
|
0.208 Newtons*seconds/kg
Standard Error 0.014
|
0.247 Newtons*seconds/kg
Standard Error .014
|
PRIMARY outcome
Timeframe: During study visit (approximately 3 hours)A measure of balance control primarily for anterior and posterior added load conditions. Normalized by body mass (kg) including the mass of the load when applicable, body height (m), and \[gravity\*body height\]\^0.5 (m/s) resulting in a unitless number.
Outcome measures
| Measure |
Standard-of-care Prosthetic Foot
n=12 Participants
Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.
|
Standard-of-care Prosthetic Foot With Heel-stiffening Wedge
n=12 Participants
Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.
|
Standard-of-care Prosthetic Foot of One Category Greater Stiffness
n=12 Participants
Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.
|
Dual Keel Prosthetic Foot
n=12 Participants
A prosthetic foot with two forefoot keels intended for load carriage applications.
|
Powered Ankle-foot
n=7 Participants
A powered prosthetic ankle-foot.
|
|---|---|---|---|---|---|
|
Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized)
Walking with no added load
|
.0172 unitless
Standard Error .0007
|
.0165 unitless
Standard Error .0007
|
.0164 unitless
Standard Error .0007
|
.0160 unitless
Standard Error .0007
|
.0153 unitless
Standard Error .0007
|
|
Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized)
Walking with load on posterior side
|
.0151 unitless
Standard Error .0007
|
.0150 unitless
Standard Error .0007
|
.0148 unitless
Standard Error .0007
|
.0149 unitless
Standard Error .0007
|
.0145 unitless
Standard Error .0007
|
|
Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized)
Walking with load on anterior side
|
.0147 unitless
Standard Error .0007
|
.0146 unitless
Standard Error .0007
|
.0147 unitless
Standard Error .0007
|
.0144 unitless
Standard Error .0007
|
.0143 unitless
Standard Error .0007
|
|
Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized)
Walking with load on prosthetic side
|
.0148 unitless
Standard Error .0007
|
.0144 unitless
Standard Error .0007
|
.0140 unitless
Standard Error .0007
|
.0139 unitless
Standard Error .0007
|
.0138 unitless
Standard Error .0007
|
|
Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized)
Walking with load on intact side
|
.0144 unitless
Standard Error .0007
|
.0148 unitless
Standard Error .0007
|
.0144 unitless
Standard Error .0007
|
.0145 unitless
Standard Error .0007
|
.0139 unitless
Standard Error .0007
|
PRIMARY outcome
Timeframe: During study visit (approximately 3 hours)A measure of balance control primarily for intact-side added load conditions. Normalized by body mass (kg) including the mass of the load when applicable, body height (m), and \[gravity\*body height\]\^0.5 (m/s) resulting in a unitless number.
Outcome measures
| Measure |
Standard-of-care Prosthetic Foot
n=12 Participants
Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.
|
Standard-of-care Prosthetic Foot With Heel-stiffening Wedge
n=12 Participants
Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.
|
Standard-of-care Prosthetic Foot of One Category Greater Stiffness
n=12 Participants
Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.
|
Dual Keel Prosthetic Foot
n=12 Participants
A prosthetic foot with two forefoot keels intended for load carriage applications.
|
Powered Ankle-foot
n=7 Participants
A powered prosthetic ankle-foot.
|
|---|---|---|---|---|---|
|
Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized)
Walking with no added load
|
0.0109 unitless
Standard Error .0009
|
.0109 unitless
Standard Error .0009
|
.0111 unitless
Standard Error .0009
|
.0109 unitless
Standard Error .0009
|
.0120 unitless
Standard Error .0010
|
|
Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized)
Walking with load on posterior side
|
.0094 unitless
Standard Error .0009
|
.0091 unitless
Standard Error .0009
|
.0104 unitless
Standard Error .0009
|
.0100 unitless
Standard Error .0009
|
.0105 unitless
Standard Error .0010
|
|
Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized)
Walking with load on anterior side
|
.0097 unitless
Standard Error .0009
|
.0096 unitless
Standard Error .0009
|
.0106 unitless
Standard Error .0009
|
.0099 unitless
Standard Error .0009
|
.0113 unitless
Standard Error .0010
|
|
Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized)
Walking with load on prosthetic side
|
.0103 unitless
Standard Error .0009
|
.0100 unitless
Standard Error .0009
|
.0101 unitless
Standard Error .0009
|
.0103 unitless
Standard Error .0009
|
.0109 unitless
Standard Error .0010
|
|
Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized)
Walking with load on intact side
|
.0104 unitless
Standard Error .0009
|
.0102 unitless
Standard Error .0009
|
.0106 unitless
Standard Error .0009
|
.0108 unitless
Standard Error .0009
|
.0114 unitless
Standard Error .0010
|
PRIMARY outcome
Timeframe: During study visit (approximately 3 hours)Positive ankle joint mechanical work over the prosthetic limb gait cycle is a measure of propulsion capability. A prosthetic foot with greater propulsion capability may enhance gait efficiency during everyday ambulation. Normalized to body mass and the added load mass when applicable.
Outcome measures
| Measure |
Standard-of-care Prosthetic Foot
n=12 Participants
Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.
|
Standard-of-care Prosthetic Foot With Heel-stiffening Wedge
n=12 Participants
Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.
|
Standard-of-care Prosthetic Foot of One Category Greater Stiffness
n=12 Participants
Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.
|
Dual Keel Prosthetic Foot
n=12 Participants
A prosthetic foot with two forefoot keels intended for load carriage applications.
|
Powered Ankle-foot
n=7 Participants
A powered prosthetic ankle-foot.
|
|---|---|---|---|---|---|
|
Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized)
Walking with no added load
|
.158 J/kg
Standard Error .010
|
.150 J/kg
Standard Error .010
|
.133 J/kg
Standard Error .010
|
.127 J/kg
Standard Error .010
|
.228 J/kg
Standard Error .025
|
|
Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized)
Walking with load on anterior side
|
.161 J/kg
Standard Error .010
|
.161 J/kg
Standard Error .010
|
.136 J/kg
Standard Error .010
|
.123 J/kg
Standard Error .010
|
.231 J/kg
Standard Error .025
|
|
Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized)
Walking with load on posterior side
|
.146 J/kg
Standard Error .010
|
.145 J/kg
Standard Error .010
|
.124 J/kg
Standard Error .010
|
.121 J/kg
Standard Error .010
|
.241 J/kg
Standard Error .025
|
|
Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized)
Walking with load on intact side
|
.152 J/kg
Standard Error .010
|
.148 J/kg
Standard Error .010
|
.126 J/kg
Standard Error .010
|
.125 J/kg
Standard Error .010
|
.244 J/kg
Standard Error .025
|
|
Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized)
Walking with load on prosthetic side
|
.158 J/kg
Standard Error .010
|
.159 J/kg
Standard Error .010
|
.136 J/kg
Standard Error .010
|
.126 J/kg
Standard Error .010
|
.238 J/kg
Standard Error .025
|
Adverse Events
Individuals With Lower Limb Amputation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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