Trial Outcomes & Findings for Biomechanical Assessment of Gait in Lower-Extremity-Amputees (NCT NCT01332123)
NCT ID: NCT01332123
Last Updated: 2016-06-09
Results Overview
Gait data was continuously recorded and was post processed to determine symmetry between left and right legs. Symmetry was computed by dividing the difference between legs by the average of both legs. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit. The overall asymmetry index was calculated as the mean of the following: max knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), knee moment, dorsi-flexion moment, plantar-flexion moment, times of max in % of the gait cycle, Stance phase % of gait cycle and step length. The kinematics asymmetry index was calculated as the mean of the following: maximal knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), the times of max in % of the gait cycle, Stance phase % of gait cycle and step length. The kinetics asymmetry index was calculated as the mean of the following variables: knee moment, dorsi-flexion moment, plantar-flexion moment, the times of max in % of the gait cycle.
COMPLETED
NA
10 participants
1 hour
2016-06-09
Participant Flow
Participant milestones
| Measure |
Alignment Perturbations
The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)
Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biomechanical Assessment of Gait in Lower-Extremity-Amputees
Baseline characteristics by cohort
| Measure |
Alignment Perturbations
n=10 Participants
The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)
Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)
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Age, Continuous
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50.4 years
STANDARD_DEVIATION 13.2 • n=5 Participants
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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9 Participants
n=5 Participants
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Age, Categorical
>=65 years
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1 Participants
n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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9 Participants
n=5 Participants
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Region of Enrollment
United States
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10 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 1 hourPopulation: Two of the recruited participants were not included in the analysis, as they had bilateral amputations. Bilateral amputation was not posted as an exclusion criteria initially, but posted unanticipated limitations during data collection and analysis.
Gait data was continuously recorded and was post processed to determine symmetry between left and right legs. Symmetry was computed by dividing the difference between legs by the average of both legs. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit. The overall asymmetry index was calculated as the mean of the following: max knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), knee moment, dorsi-flexion moment, plantar-flexion moment, times of max in % of the gait cycle, Stance phase % of gait cycle and step length. The kinematics asymmetry index was calculated as the mean of the following: maximal knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), the times of max in % of the gait cycle, Stance phase % of gait cycle and step length. The kinetics asymmetry index was calculated as the mean of the following variables: knee moment, dorsi-flexion moment, plantar-flexion moment, the times of max in % of the gait cycle.
Outcome measures
| Measure |
Alignment Perturbations
n=8 Participants
The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)
All participants were subjected to the same 5 interventions (neutral alignment and 4 perturbations as detailed above) in sequence to allow repeated measures (within-subject) comparisons.
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Overall Asymmetry Index
max knee flex
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0.064 unit-less index (0 = perfect symmetry)
Standard Deviation 0.053
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Overall Asymmetry Index
max dorsiflex
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0.352 unit-less index (0 = perfect symmetry)
Standard Deviation 0.372
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Overall Asymmetry Index
max plantarflex 1
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0.541 unit-less index (0 = perfect symmetry)
Standard Deviation 0.264
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Overall Asymmetry Index
max pflex 2
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1.481 unit-less index (0 = perfect symmetry)
Standard Deviation 0.469
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Overall Asymmetry Index
% time of max knee flex
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0.037 unit-less index (0 = perfect symmetry)
Standard Deviation 0.025
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Overall Asymmetry Index
% time of max dorsiflex
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0.111 unit-less index (0 = perfect symmetry)
Standard Deviation 0.173
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Overall Asymmetry Index
% time of pflex 1
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0.238 unit-less index (0 = perfect symmetry)
Standard Deviation 0.137
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Overall Asymmetry Index
% time of pflex 2
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0.038 unit-less index (0 = perfect symmetry)
Standard Deviation 0.026
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Overall Asymmetry Index
max knee moment
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0.792 unit-less index (0 = perfect symmetry)
Standard Deviation 0.599
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Overall Asymmetry Index
% time of max knee moment
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0.794 unit-less index (0 = perfect symmetry)
Standard Deviation 0.589
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Overall Asymmetry Index
max dflex moment
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0.137 unit-less index (0 = perfect symmetry)
Standard Deviation 0.129
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Overall Asymmetry Index
% time of max dflex moment
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0.178 unit-less index (0 = perfect symmetry)
Standard Deviation 0.359
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Overall Asymmetry Index
max pflex moment
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0.652 unit-less index (0 = perfect symmetry)
Standard Deviation 0.598
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Overall Asymmetry Index
% time of max pflex moment
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0.437 unit-less index (0 = perfect symmetry)
Standard Deviation 0.556
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Overall Asymmetry Index
stance phase % of cycle
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0.041 unit-less index (0 = perfect symmetry)
Standard Deviation 0.026
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Overall Asymmetry Index
step length
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0.076 unit-less index (0 = perfect symmetry)
Standard Deviation 0.078
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Overall Asymmetry Index
overall asymmetry index
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0.373 unit-less index (0 = perfect symmetry)
Standard Deviation 0.124
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Overall Asymmetry Index
kinematics asymmetry index
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0.298 unit-less index (0 = perfect symmetry)
Standard Deviation 0.071
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Overall Asymmetry Index
kinetics asymmetry index
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0.498 unit-less index (0 = perfect symmetry)
Standard Deviation 0.339
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SECONDARY outcome
Timeframe: 1 hourSubjects were wearing a wireless heart rate monitor. The respective readings were noted and assessed during and immediately following the trials to estimate individual exertion rates. Changes in heart rate between resting and exertion across the sample were investigated to be able to interpret the primary outcome measures and to discuss limitations of the protocol. Unequal exertion rates within the sample would cause uneven trends biomechanical changes that are related to exertion.
Outcome measures
| Measure |
Alignment Perturbations
n=8 Participants
The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)
All participants were subjected to the same 5 interventions (neutral alignment and 4 perturbations as detailed above) in sequence to allow repeated measures (within-subject) comparisons.
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|---|---|
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Heart Rate Change
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55.75 beats/minute
Interval 31.0 to 78.0
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Adverse Events
Alignment Perturbations
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alignment Perturbations
n=10 participants at risk
The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)
Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)
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General disorders
Exertion
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50.0%
5/10 • Number of events 5
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place