Study of Medial-Lateral Center of Pressure Displacement in Unilateral Transfemoral Amputees

NCT ID: NCT02299674

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Unilateral Transfemoral Amputation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Persons with unilateral transfemoral amputation

Level overground ambulation

Intervention Type OTHER

Interventions

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Level overground ambulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Southern California Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Dana Craig

Health System Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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V.A. Long Beach Healthcare System

Long Beach, California, United States

Site Status

Countries

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United States

References

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Au, S. K., Weber, J., & Herr, H. (2009). Powered Ankle-Foot Prosthesis Improves Walking Metabolic Economy. IEEE Transactions on Robotics, 25(1), 51-66.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11747890 (View on PubMed)

Herr 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.

Reference Type BACKGROUND
PMID: 21752817 (View on PubMed)

Hof 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.

Reference Type BACKGROUND
PMID: 16740390 (View on PubMed)

Kadaba 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.

Reference Type BACKGROUND
PMID: 2324857 (View on PubMed)

Nolan 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.

Reference Type BACKGROUND
PMID: 21515889 (View on PubMed)

Orendurff 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.

Reference Type BACKGROUND
PMID: 15685471 (View on PubMed)

Schmid 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.

Reference Type BACKGROUND
PMID: 15760740 (View on PubMed)

Turnbull 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.

Reference Type BACKGROUND
PMID: 8607759 (View on PubMed)

Other Identifiers

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1316

Identifier Type: -

Identifier Source: org_study_id

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