Skip to content

Biomechanical Assessment of Gait in Lower-Extremity-Amputees

Biomechanical Assessment of Gait in Lower-Extremity-Amputees

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01332123
Enrollment
10
Registered
2011-04-08
Start date
2011-04-30
Completion date
2012-08-31
Last updated
2016-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthesis User

Brief summary

This study is investigating the influence of several simulated real life conditions on the symmetry of gait with trans-tibial prostheses Hypotheses: It is hypothesized that the observable differences in gait pattern between amputees can be detected by a combination of forces and moments that are measured internally in the prosthesis, and electromyography data. It is further hypothesized that changing conditions such as uneven walking surface, prosthetic misalignment or user fatigue are characterized by typical values in the measured data or combinations thereof.

Detailed description

In amputee walking, an optimal static alignment of the artificial leg is important in order to achieve the best possible performance. Comfort, energy expenditure, mobility and walking speed should ideally be similar to those of able bodied persons. Of course, amputation level, overall health status and other factors often pose certain individual limitations that may prevent an amputee from reaching this goal. Irrespective of that, the artificial leg must be aligned properly to eliminate unnecessary inhibitions. Apart from manufacturing a well fitting socket, and selecting the appropriate functional components of the prosthesis, the prosthetist has to routinely optimize the static alignment during the fitting process. Hereby, objective measures and guidelines are scarce. Despite various more or less useful tools that are available, the alignment optimization in praxis is often based on subjective gait assessment and rules of thumb. Commonly accepted is the notion, that the gait pattern should be most symmetrically, that is step lengths, stance times, knee angles etc. should be identical between sound and prosthetic leg. There are different questions that our study wants to address: Is gait symmetry indeed a valid measure of prosthetic performance (e.i. is it the most energy efficient way to walk)? How does the gait pattern change when the prosthesis user walks on different surfaces, becomes tired or tries to compensate for a less-than-optimal prosthesis fit? How can gait symmetry be objectively assessed without using an expensive motion analysis laboratory? We hope that our findings will provide practically useful information that can help improve prosthetic fittings in the field. The study will be based on data from up to 15 trans-tibial prosthesis users. Participants will walk with their standard prosthesis, which will be equipped with a small sensor unit for the measurement of forces and moments during walking. The muscle activity of the thigh muscles will be measured using surface EMG sensors. All of the data collection will take place at the USR facilities (115 E Reindl Way, Milwaukee), where a multi camera motion analysis system is set up. Trials will require an overall time commitment of 5 hours at most, and will include normal walking, walking on carpet and gravel, walking up and down stairs, walking with fatigued thigh muscles.

Interventions

DEVICEAlignment perturbations

Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)

Sponsors

University of Wisconsin, Milwaukee
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Trans tibial amputation * Able to walk 30 minutes comfortably * Modular prosthesis

Exclusion criteria

* Prosthesis does not provide enough space between socket and foot module to fit the mobile measuring unit * Physically or mentally unable to perform the required tasks

Design outcomes

Primary

MeasureTime frameDescription
Overall Asymmetry Index1 hourGait 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.

Secondary

MeasureTime frameDescription
Heart Rate Change1 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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)
10
Total10

Baseline characteristics

CharacteristicAlignment Perturbations
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
Age, Continuous50.4 years
STANDARD_DEVIATION 13.2
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
1 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
5 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

Overall Asymmetry Index

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.

Time frame: 1 hour

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Alignment PerturbationsOverall Asymmetry Indexmax knee flex0.064 unit-less index (0 = perfect symmetry)Standard Deviation 0.053
Alignment PerturbationsOverall Asymmetry Indexmax dorsiflex0.352 unit-less index (0 = perfect symmetry)Standard Deviation 0.372
Alignment PerturbationsOverall Asymmetry Indexmax plantarflex 10.541 unit-less index (0 = perfect symmetry)Standard Deviation 0.264
Alignment PerturbationsOverall Asymmetry Indexmax pflex 21.481 unit-less index (0 = perfect symmetry)Standard Deviation 0.469
Alignment PerturbationsOverall Asymmetry Index% time of max knee flex0.037 unit-less index (0 = perfect symmetry)Standard Deviation 0.025
Alignment PerturbationsOverall Asymmetry Index% time of max dorsiflex0.111 unit-less index (0 = perfect symmetry)Standard Deviation 0.173
Alignment PerturbationsOverall Asymmetry Index% time of pflex 10.238 unit-less index (0 = perfect symmetry)Standard Deviation 0.137
Alignment PerturbationsOverall Asymmetry Index% time of pflex 20.038 unit-less index (0 = perfect symmetry)Standard Deviation 0.026
Alignment PerturbationsOverall Asymmetry Indexmax knee moment0.792 unit-less index (0 = perfect symmetry)Standard Deviation 0.599
Alignment PerturbationsOverall Asymmetry Index% time of max knee moment0.794 unit-less index (0 = perfect symmetry)Standard Deviation 0.589
Alignment PerturbationsOverall Asymmetry Indexmax dflex moment0.137 unit-less index (0 = perfect symmetry)Standard Deviation 0.129
Alignment PerturbationsOverall Asymmetry Index% time of max dflex moment0.178 unit-less index (0 = perfect symmetry)Standard Deviation 0.359
Alignment PerturbationsOverall Asymmetry Indexstep length0.076 unit-less index (0 = perfect symmetry)Standard Deviation 0.078
Alignment PerturbationsOverall Asymmetry Indexmax pflex moment0.652 unit-less index (0 = perfect symmetry)Standard Deviation 0.598
Alignment PerturbationsOverall Asymmetry Index% time of max pflex moment0.437 unit-less index (0 = perfect symmetry)Standard Deviation 0.556
Alignment PerturbationsOverall Asymmetry Indexstance phase % of cycle0.041 unit-less index (0 = perfect symmetry)Standard Deviation 0.026
Alignment PerturbationsOverall Asymmetry Indexoverall asymmetry index0.373 unit-less index (0 = perfect symmetry)Standard Deviation 0.124
Alignment PerturbationsOverall Asymmetry Indexkinematics asymmetry index0.298 unit-less index (0 = perfect symmetry)Standard Deviation 0.071
Alignment PerturbationsOverall Asymmetry Indexkinetics asymmetry index0.498 unit-less index (0 = perfect symmetry)Standard Deviation 0.339
Secondary

Heart Rate Change

Subjects 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.

Time frame: 1 hour

ArmMeasureValue (MEAN)
Alignment PerturbationsHeart Rate Change55.75 beats/minute

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026