Unilateral Transfemoral AmputationNCT02299674
Study of Medial-Lateral Center of Pressure Displacement in Unilateral Transfemoral Amputees
An observational study of Unilateral Transfemoral Amputation, run by Southern California Institute for Research and Education at 1 site in United States.
Trial summary
The purpose of this study is to examine the path and velocity of the center of mass (CoM) and center of pressure (CoP) during double support of persons walking with a unilateral above-the-knee prosthesis and determine the effects of prosthetic foot stiffness and effective length on CoM and CoP.Persons with a lower… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Unilateral Transfemoral Amputation
- What is being tested?
- Level overground ambulation
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Persons with unilateral transfemoral amputation who are ambulatory with a prosthesis and no assistive device.
Who may be able to join
- Participants must have a transfermoral amputation and use an above-the-knee prosthesis with an articulating knee joint on a daily basis.
- Participants must be male.
- Age greater than or equal to 18 years, but less than 65 years.
- Participants must have no known pathology or comorbidites that would affect their ambulatory ability
- Ability to tolerate walking for a minimum of 100 yards over the course of a two and a half hour time period.
- Ability to walk one block without needing to rest.
Who cannot join
- Use of ambulatory aids such as canes or crutches.
- Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
- Bilateral amputations.
Trial locations and contacts
1 site in 1 country.
United States1 site
V.A. Long Beach Healthcare System
Long Beach, California, 90822
About this study
Official title: Investigation of Medial Lateral Displacement of Center of Pressure and Center of Mass During Double Support in Men With Unilateral Transfemoral Amputations.
The purpose of this study is to examine the path and velocity of the center of mass (CoM) and center of pressure (CoP) during double support of persons walking with a unilateral above-the-knee prosthesis and determine the effects of prosthetic foot stiffness and effective length on CoM and CoP.Persons with a lower limb amputation walk with compensatory movements that affect the smooth trajectory of the center of mass (CoM) during weight transfer. The lack of control in the foot/ankle complex reduces fine motor movements, influencing the progression of the CoM and transfer of ground reaction forces represented by the center of pressure (CoP). Without control of the ankle joint, prosthetic users "fall" off of their trailing prosthetic limb during weight transfer, resulting in much more abrupt CoM and CoP transfers from trailing to leading limb. These abrupt movements during transfer not only increase stress on the sound limb, but also decrease the subject's energy efficiency during ambulation. The current study will further examine the CoP path and velocity in relation to the CoM path and velocity during double support of men with a transfemoral prosthesis, as well as explore how prosthetic foot ankle stiffness and effective length affects the CoP path and velocity.
- Conditions
- Unilateral Transfemoral Amputation
- Being tested
- Level overground ambulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level overground ambulationOther
| Study group | Role | What they receive |
|---|---|---|
| Persons with unilateral transfemoral amputation | Not described Receives: Other: Level overground ambulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of Pressure Velocity
The Center of Pressure velocity in the X and Y direction [cm/sec] will be collected using a motion capture system and forceplates during a single session. This data will be collected during a single 2.5 hour data collection session. The time frame is specifically the Double Support phase of the gait cycle.
Measured: Double Support Phase of Gait Cycle (2.5 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Unilateral Transfemoral AmputationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Craig, Southern California Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299674
- Sponsor's protocol ID
- 1316
- Status last verified
- May 2017
- First submitted
- 19 Nov 2014
- Last updated
- 3 May 2017
- Results posted
- No
Publications
Au, S. K., Weber, J., & Herr, H. (2009). Powered Ankle-Foot Prosthesis Improves Walking Metabolic Economy. IEEE Transactions on Robotics, 25(1), 51-66.
Donelan JM, Kram R, Kuo AD. Simultaneous positive and negative external mechanical work in human walking. J Biomech. 2002 Jan;35(1):117-24. doi: 10.1016/s0021-9290(01)00169-5.
PubMed 11747890Herr HM, Grabowski AM. Bionic ankle-foot prosthesis normalizes walking gait for persons with leg amputation. Proc Biol Sci. 2012 Feb 7;279(1728):457-64. doi: 10.1098/rspb.2011.1194. Epub 2011 Jul 13.
PubMed 21752817Hof AL, van Bockel RM, Schoppen T, Postema K. Control of lateral balance in walking. Experimental findings in normal subjects and above-knee amputees. Gait Posture. 2007 Feb;25(2):250-8. doi: 10.1016/j.gaitpost.2006.04.013. Epub 2006 Jun 5.
PubMed 16740390Kadaba MP, Ramakrishnan HK, Wootten ME. Measurement of lower extremity kinematics during level walking. J Orthop Res. 1990 May;8(3):383-92. doi: 10.1002/jor.1100080310.
PubMed 2324857Nolan KJ, Yarossi M. Weight transfer analysis in adults with hemiplegia using ankle foot orthosis. Prosthet Orthot Int. 2011 Mar;35(1):45-53. doi: 10.1177/0309364610393061.
PubMed 21515889Orendurff MS, Segal AD, Klute GK, Berge JS, Rohr ES, Kadel NJ. The effect of walking speed on center of mass displacement. J Rehabil Res Dev. 2004 Nov-Dec;41(6A):829-34. doi: 10.1682/jrrd.2003.10.0150.
PubMed 15685471Schmid M, Beltrami G, Zambarbieri D, Verni G. Centre of pressure displacements in trans-femoral amputees during gait. Gait Posture. 2005 Apr;21(3):255-62. doi: 10.1016/j.gaitpost.2004.01.016.
PubMed 15760740Turnbull GI, Charteris J, Wall JC. Deficiencies in standing weight shifts by ambulant hemiplegic subjects. Arch Phys Med Rehabil. 1996 Apr;77(4):356-62. doi: 10.1016/s0003-9993(96)90084-2.
PubMed 8607759
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Medial Lateral Displacement of Center of Pressure and Center of Mass During Double Support in Men With Unilateral Transfemoral Amputations.
- ClinicalTrials.gov ID
- NCT02299674
- Acronym / sponsor ID
- 1316
- Conditions
- Unilateral Transfemoral Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the path and velocity of the center of mass (CoM) and center of pressure (CoP) during double support of persons walking with a unilateral above-the-knee prosthesis and determine the effects of prosthetic foot stiffness and effective length on CoM and CoP.Persons with a lower limb amputation walk with compensatory movements that affect the smooth trajectory of the center of mass (CoM) during weight transfer. The lack of control in the foot/ankle complex reduces fine motor movements, influencing the progression of the CoM and transfer of ground reaction forces represented by the center of pressure (CoP). Without control of the ankle joint, prosthetic users "fall" off of their trailing prosthetic limb during weight transfer, resulting in much more abrupt CoM and CoP transfers from trailing to leading limb. These abrupt movements during transfer not only increase stress on the sound limb, but also decrease the subject's energy efficiency during ambulation. The current study will further examine the CoP path and velocity in relation to the CoM path and velocity during double support of men with a transfemoral prosthesis, as well as explore how prosthetic foot ankle stiffness and effective length affects the CoP path and velocity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with unilateral transfemoral amputation | – | Other: Level overground ambulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with unilateral transfemoral amputation who are ambulatory with a prosthesis and no assistive device.
Key inclusion criteria (6 listed)
- Participants must have a transfermoral amputation and use an above-the-knee prosthesis with an articulating knee joint on a daily basis.
- Participants must be male.
- Age greater than or equal to 18 years, but less than 65 years.
- Participants must have no known pathology or comorbidites that would affect their ambulatory ability
- Ability to tolerate walking for a minimum of 100 yards over the course of a two and a half hour time period.
Key exclusion criteria (3 listed)
- Use of ambulatory aids such as canes or crutches.
- Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
- Bilateral amputations.
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 |
|---|---|---|
| Level overground ambulation | Other | Persons with unilateral transfemoral amputation |
Primary outcome
Center of Pressure Velocity
Time frame: Double Support Phase of Gait Cycle (2.5 hour)
The Center of Pressure velocity in the X and Y direction [cm/sec] will be collected using a motion capture system and forceplates during a single session. This data will be collected during a single 2.5 hour data collection session. The time frame is specifically the Double Support phase of the gait cycle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- BackgroundAu, S. K., Weber, J., & Herr, H. (2009). Powered Ankle-Foot Prosthesis Improves Walking Metabolic Economy. IEEE Transactions on Robotics, 25(1), 51-66.
- Background: PubMed 11747890Donelan JM, Kram R, Kuo AD. Simultaneous positive and negative external mechanical work in human walking. J Biomech. 2002 Jan;35(1):117-24. doi: 10.1016/s0021-9290(01)00169-5.
- Background: PubMed 21752817Herr HM, Grabowski AM. Bionic ankle-foot prosthesis normalizes walking gait for persons with leg amputation. Proc Biol Sci. 2012 Feb 7;279(1728):457-64. doi: 10.1098/rspb.2011.1194. Epub 2011 Jul 13.
- Background: PubMed 16740390Hof AL, van Bockel RM, Schoppen T, Postema K. Control of lateral balance in walking. Experimental findings in normal subjects and above-knee amputees. Gait Posture. 2007 Feb;25(2):250-8. doi: 10.1016/j.gaitpost.2006.04.013. Epub 2006 Jun 5.
- Background: PubMed 2324857Kadaba MP, Ramakrishnan HK, Wootten ME. Measurement of lower extremity kinematics during level walking. J Orthop Res. 1990 May;8(3):383-92. doi: 10.1002/jor.1100080310.
- Background: PubMed 21515889Nolan KJ, Yarossi M. Weight transfer analysis in adults with hemiplegia using ankle foot orthosis. Prosthet Orthot Int. 2011 Mar;35(1):45-53. doi: 10.1177/0309364610393061.
- Background: PubMed 15685471Orendurff MS, Segal AD, Klute GK, Berge JS, Rohr ES, Kadel NJ. The effect of walking speed on center of mass displacement. J Rehabil Res Dev. 2004 Nov-Dec;41(6A):829-34. doi: 10.1682/jrrd.2003.10.0150.
- Background: PubMed 15760740Schmid M, Beltrami G, Zambarbieri D, Verni G. Centre of pressure displacements in trans-femoral amputees during gait. Gait Posture. 2005 Apr;21(3):255-62. doi: 10.1016/j.gaitpost.2004.01.016.
- Background: PubMed 8607759Turnbull GI, Charteris J, Wall JC. Deficiencies in standing weight shifts by ambulant hemiplegic subjects. Arch Phys Med Rehabil. 1996 Apr;77(4):356-62. doi: 10.1016/s0003-9993(96)90084-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Transfemoral Amputation, run by Southern California Institute for Research and Education 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 6 inclusion and 3 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 3 May 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Center of Pressure Velocity (time frame: Double Support Phase of Gait Cycle (2.5 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02299674, which also lists 9 linked publications.
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 3 May 2017.