Trial Outcomes & Findings for Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback? (NCT NCT03974945)
NCT ID: NCT03974945
Last Updated: 2025-07-15
Results Overview
The investigators measured peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline hGRFpeak and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak. Thus, participants performed 9 trials per prosthesis.
COMPLETED
12 participants
18 trials that are 5 minutes in length
2025-07-15
Participant Flow
Participant milestones
| Measure |
Participants With Transtibial Amputation
The investigators will recruit participants with unilateral transtibial amputations who are at or above a K3 Medicare functional classification level (MFCL), and 18-60 years old. A K3 MFCL means that a person has the ability or potential for ambulation with variable cadence. A person at K3 MFCL is a typical community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic or exercise activity that demands prosthetic use beyond simple locomotion.
Passive-elastic prosthetic foot: The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects walk using their own passive-elastic prosthesis with and without visual feedback of peak propulsive force targets.
Powered ankle-foot prosthesis: The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects walk using a battery-powered ankle-foot prosthesis with and without visual feedback of peak propulsive force targets.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Walking Performance Improve When Veterans With Leg Amputations Are Given Visual Feedback?
Baseline characteristics by cohort
| Measure |
Participants With Transtibial Amputation
n=12 Participants
The investigators will recruit participants with unilateral transtibial amputations who are at or above a K3 Medicare functional classification level (MFCL), and 18-60 years old. A K3 MFCL means that a person has the ability or potential for ambulation with variable cadence. A person at K3 MFCL is a typical community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic or exercise activity that demands prosthetic use beyond simple locomotion.
Passive-elastic prosthetic foot: The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects walk using their own passive-elastic prosthesis with and without visual feedback of peak propulsive force targets.
Powered ankle-foot prosthesis: The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects walk using a battery-powered ankle-foot prosthesis with and without visual feedback of peak propulsive force targets.
|
|---|---|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
10 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
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 trials that are 5 minutes in lengthThe investigators measured peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline hGRFpeak and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak. Thus, participants performed 9 trials per prosthesis.
Outcome measures
| Measure |
ESAR - BL
n=12 Participants
Baseline no feedback
|
ESAR - 0FB
n=12 Participants
Baseline feedback
|
ESAR - 0RT
n=12 Participants
Baseline retention
|
ESAR - 20FB
n=12 Participants
+20% feedback
|
ESAR - 20RT
n=12 Participants
+20% retention
|
ESAR - 40FB
n=12 Participants
+40% feedback
|
ESAR - 40RT
n=12 Participants
+40% retention
|
ESAR - SymFB
n=12 Participants
Symmetry feedback
|
ESAR - SymRT
n=12 Participants
Symmetry retention
|
BiOM - BL
n=12 Participants
Baseline no feedback
|
BiOM - 0FB
n=12 Participants
Baseline feedback
|
BiOM - 0RT
n=12 Participants
Baseline retention
|
BiOM - 20FB
n=12 Participants
+20% feedback
|
BiOM - 20RT
n=12 Participants
+20% retention
|
BiOM - 40FB
n=12 Participants
+40% feedback
|
BiOM - 40RT
n=12 Participants
+40% retention
|
BiOM - SymFB
n=12 Participants
Symmetry feedback
|
BiOM - SymRT
n=12 Participants
Symmetry retention
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Affected Leg Peak Propulsive Horizontal Ground Reaction Force
|
0.151 proportion of body weight
Standard Deviation 0.022
|
0.145 proportion of body weight
Standard Deviation 0.019
|
0.166 proportion of body weight
Standard Deviation 0.021
|
0.150 proportion of body weight
Standard Deviation 0.022
|
0.175 proportion of body weight
Standard Deviation 0.020
|
0.147 proportion of body weight
Standard Deviation 0.018
|
0.145 proportion of body weight
Standard Deviation 0.022
|
0.171 proportion of body weight
Standard Deviation 0.031
|
0.146 proportion of body weight
Standard Deviation 0.022
|
0.169 proportion of body weight
Standard Deviation 0.011
|
0.160 proportion of body weight
Standard Deviation 0.011
|
0.178 proportion of body weight
Standard Deviation 0.021
|
0.161 proportion of body weight
Standard Deviation 0.011
|
0.186 proportion of body weight
Standard Deviation 0.020
|
0.166 proportion of body weight
Standard Deviation 0.014
|
0.157 proportion of body weight
Standard Deviation 0.018
|
0.174 proportion of body weight
Standard Deviation 0.019
|
0.172 proportion of body weight
Standard Deviation 0.024
|
PRIMARY outcome
Timeframe: 18 trials that are 5 minutes in lengthThe investigators measured net metabolic power while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak. Thus, participants performed 9 trials per prosthesis.
Outcome measures
| Measure |
ESAR - BL
n=12 Participants
Baseline no feedback
|
ESAR - 0FB
n=12 Participants
Baseline feedback
|
ESAR - 0RT
n=12 Participants
Baseline retention
|
ESAR - 20FB
n=12 Participants
+20% feedback
|
ESAR - 20RT
n=12 Participants
+20% retention
|
ESAR - 40FB
n=12 Participants
+40% feedback
|
ESAR - 40RT
n=12 Participants
+40% retention
|
ESAR - SymFB
n=12 Participants
Symmetry feedback
|
ESAR - SymRT
n=12 Participants
Symmetry retention
|
BiOM - BL
n=12 Participants
Baseline no feedback
|
BiOM - 0FB
n=12 Participants
Baseline feedback
|
BiOM - 0RT
n=12 Participants
Baseline retention
|
BiOM - 20FB
n=12 Participants
+20% feedback
|
BiOM - 20RT
n=12 Participants
+20% retention
|
BiOM - 40FB
n=12 Participants
+40% feedback
|
BiOM - 40RT
n=12 Participants
+40% retention
|
BiOM - SymFB
n=12 Participants
Symmetry feedback
|
BiOM - SymRT
n=12 Participants
Symmetry retention
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Net Metabolic Power
|
2.967 Watts per kg
Standard Deviation 0.345
|
3.141 Watts per kg
Standard Deviation 0.275
|
3.020 Watts per kg
Standard Deviation 0.230
|
3.338 Watts per kg
Standard Deviation 0.422
|
3.124 Watts per kg
Standard Deviation 0.316
|
3.478 Watts per kg
Standard Deviation 0.488
|
3.168 Watts per kg
Standard Deviation 0.409
|
3.330 Watts per kg
Standard Deviation 0.554
|
3.062 Watts per kg
Standard Deviation 0.317
|
2.852 Watts per kg
Standard Deviation 0.413
|
2.979 Watts per kg
Standard Deviation 0.436
|
2.938 Watts per kg
Standard Deviation 0.425
|
3.268 Watts per kg
Standard Deviation 0.561
|
3.022 Watts per kg
Standard Deviation 0.473
|
3.314 Watts per kg
Standard Deviation 0.540
|
3.013 Watts per kg
Standard Deviation 0.418
|
2.974 Watts per kg
Standard Deviation 0.539
|
2.862 Watts per kg
Standard Deviation 0.399
|
PRIMARY outcome
Timeframe: 18 trials that are 5 minutes in lengthThe investigators measured ground reaction forces and calculated individual leg work during step to step transitions while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak.
Outcome measures
| Measure |
ESAR - BL
n=12 Participants
Baseline no feedback
|
ESAR - 0FB
n=12 Participants
Baseline feedback
|
ESAR - 0RT
n=12 Participants
Baseline retention
|
ESAR - 20FB
n=12 Participants
+20% feedback
|
ESAR - 20RT
n=12 Participants
+20% retention
|
ESAR - 40FB
n=12 Participants
+40% feedback
|
ESAR - 40RT
n=12 Participants
+40% retention
|
ESAR - SymFB
n=12 Participants
Symmetry feedback
|
ESAR - SymRT
n=12 Participants
Symmetry retention
|
BiOM - BL
n=12 Participants
Baseline no feedback
|
BiOM - 0FB
n=12 Participants
Baseline feedback
|
BiOM - 0RT
n=12 Participants
Baseline retention
|
BiOM - 20FB
n=12 Participants
+20% feedback
|
BiOM - 20RT
n=12 Participants
+20% retention
|
BiOM - 40FB
n=12 Participants
+40% feedback
|
BiOM - 40RT
n=12 Participants
+40% retention
|
BiOM - SymFB
n=12 Participants
Symmetry feedback
|
BiOM - SymRT
n=12 Participants
Symmetry retention
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Trailing Affected Leg Positive Work
|
9.859 Joules
Standard Deviation 3.392
|
10.321 Joules
Standard Deviation 4.325
|
10.773 Joules
Standard Deviation 4.326
|
10.212 Joules
Standard Deviation 4.419
|
11.203 Joules
Standard Deviation 4.652
|
10.319 Joules
Standard Deviation 4.463
|
9.592 Joules
Standard Deviation 4.212
|
11.384 Joules
Standard Deviation 3.941
|
10.410 Joules
Standard Deviation 4.642
|
14.624 Joules
Standard Deviation 5.800
|
14.108 Joules
Standard Deviation 4.835
|
15.211 Joules
Standard Deviation 6.363
|
13.597 Joules
Standard Deviation 5.413
|
15.274 Joules
Standard Deviation 6.466
|
14.071 Joules
Standard Deviation 4.450
|
12.818 Joules
Standard Deviation 4.203
|
14.730 Joules
Standard Deviation 6.242
|
15.078 Joules
Standard Deviation 5.575
|
PRIMARY outcome
Timeframe: 18 trials that are 5 minutes in lengthThe investigators measured ground reaction forces and calculated individual leg work during step to step transitions while participants with a transtibial amputation walked at 1.25 m/s for 18 trials that were 5 minutes each over 3 separate days using an elastic energy storage and return (ESAR) and stance-phase powered ankle-foot (BiOM) prosthesis. During the first trial we measured their baseline peak propulsive horizontal ground reaction force (hGRFpeak) from the affected leg and then for the subsequent trials we provided a trial with visual feedback (FB) targets of hGRFpeak relative to their baseline (BL) trial using a monitor placed at eye level as well as VF of symmetric (Sym) targets of hGRFpeak from both legs and then removed the visual feedback during a retention (RT) trial that immediately followed the VF trial. The order of trials was randomized and included targets of 0, +20, and +40% of baseline hGRFpeak as well as a Sym target of hGRFpeak.
Outcome measures
| Measure |
ESAR - BL
n=12 Participants
Baseline no feedback
|
ESAR - 0FB
n=12 Participants
Baseline feedback
|
ESAR - 0RT
n=12 Participants
Baseline retention
|
ESAR - 20FB
n=12 Participants
+20% feedback
|
ESAR - 20RT
n=12 Participants
+20% retention
|
ESAR - 40FB
n=12 Participants
+40% feedback
|
ESAR - 40RT
n=12 Participants
+40% retention
|
ESAR - SymFB
n=12 Participants
Symmetry feedback
|
ESAR - SymRT
n=12 Participants
Symmetry retention
|
BiOM - BL
n=12 Participants
Baseline no feedback
|
BiOM - 0FB
n=12 Participants
Baseline feedback
|
BiOM - 0RT
n=12 Participants
Baseline retention
|
BiOM - 20FB
n=12 Participants
+20% feedback
|
BiOM - 20RT
n=12 Participants
+20% retention
|
BiOM - 40FB
n=12 Participants
+40% feedback
|
BiOM - 40RT
n=12 Participants
+40% retention
|
BiOM - SymFB
n=12 Participants
Symmetry feedback
|
BiOM - SymRT
n=12 Participants
Symmetry retention
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Leading Unaffected Leg Negative Work
|
-15.373 Joules
Standard Deviation 4.191
|
-14.438 Joules
Standard Deviation 4.394
|
-15.981 Joules
Standard Deviation 6.225
|
-14.363 Joules
Standard Deviation 4.590
|
-17.781 Joules
Standard Deviation 7.167
|
-14.018 Joules
Standard Deviation 5.195
|
-14.389 Joules
Standard Deviation 4.451
|
-15.350 Joules
Standard Deviation 6.056
|
-14.223 Joules
Standard Deviation 5.517
|
-15.781 Joules
Standard Deviation 6.674
|
-15.011 Joules
Standard Deviation 6.284
|
-17.975 Joules
Standard Deviation 5.403
|
-14.713 Joules
Standard Deviation 5.840
|
-18.475 Joules
Standard Deviation 7.963
|
-16.032 Joules
Standard Deviation 6.839
|
-15.507 Joules
Standard Deviation 5.169
|
-15.755 Joules
Standard Deviation 6.950
|
-14.918 Joules
Standard Deviation 5.957
|
Adverse Events
Participants With Transtibial Amputation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alena Grabowski
Rocky Mountain Regional Department of Veterans Affairs
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place