Prosthesis UserNCT01332123
Biomechanical Assessment of Gait in Lower-Extremity-Amputees
A study testing Alignment perturbations in people with Prosthesis User, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis User
- What is being tested?
- Alignment perturbations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Trans tibial amputation
- Able to walk 30 minutes comfortably
- Modular prosthesis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Prosthesis User
- Being tested
- Alignment perturbations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alignment perturbationsDevice
Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)
| Study group | Role | What they receive |
|---|---|---|
| Alignment perturbations | Experimental | The following modifications will be 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) Receives: Device: Alignment perturbations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (1)
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prosthesis UserStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goeran Fiedler, University of Wisconsin, Milwaukee
- Investigators
- Brooke A Slavens, PhD, Principal investigator, UWM CHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332123
- Sponsor's protocol ID
- UWM-11.254
- Status last verified
- Jun 2016
- First submitted
- 6 Apr 2011
- Last updated
- 9 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Assessment of Gait in Lower-Extremity-Amputees
- ClinicalTrials.gov ID
- NCT01332123
- Acronym / sponsor ID
- UWM-11.254
- Conditions
- Prosthesis User
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Posted 9 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alignment perturbations | Experimental | Device: Alignment perturbationsThe following modifications will be 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Trans tibial amputation
- Able to walk 30 minutes comfortably
- Modular prosthesis
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alignment perturbationsIncreased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position) | Device | Alignment perturbations |
Primary outcome
Overall Asymmetry Index
Time frame: 1 hour
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.
1 secondary outcome
Heart Rate Change
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooke A Slavens, PhD principal investigator
UWM CHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alignment perturbations in people with Prosthesis User, run by University of Wisconsin, Milwaukee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Asymmetry Index (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.