Clinical trial NCT04330274: Comparison of Different Amputation Levels
Official title: Comparison of Different Amputation Levels in Terms of Balance Parameters and Plantar Pressure Distribution; Lower Extremity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputee
Plantar Pressure Distrubution
Balance
Keywords: amputee,plantar pressure, balance
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unilateral transtibial and transfemoral amputees

Brief summary: Lower limb amputation is a factor that changes the individual's weight transfer, gait pattern, and trunk balance. This change plantar pressure distribution of both side and cause a series of problems to be exposed over time according to level of amputation. The aim of this study is to reveal the relationship between amputation level-postural balance and amputation level-plantar pressure distribution.


Eligibility criteria: Inclusion Criteria:

* Being unilateral transfemoral or transtibial amputee
* Have the level of perception to understand and apply the commands given
* Having sedantary life styles

Exclusion Criteria:

* Having a neurological or orthopedic disorder that may affect standing posture and balance
* The presence of pain that can affect standing posture and balance
* Visual impairment that impairs the gait pattern and balance

Primary outcomes:
measure: Measurement of plantar pressure distrubution
timeFrame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
measure: Measurement of plantar pressure distrubution
timeFrame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
measure: Determination of center of pressure
timeFrame: Change from baseline center of pressure at second 10, second 20 and second 30.
measure: Determination of center of pressure
timeFrame: Change from baseline center of pressure at second 10, second 20 and second 30.
measure: Measurement of plantar pressure distrubution
timeFrame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
measure: Measurement of plantar pressure distrubution
timeFrame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
measure: Determination of center of pressure
timeFrame: Change from baseline center of pressure at second 10, second 20 and second 30.
measure: Determination of center of pressure
timeFrame: Change from baseline center of pressure at second 10, second 20 and second 30.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: yasar tatar
role: STUDY_DIRECTOR
References:
citation: Jayakaran P, Johnson GM, Sullivan SJ. Postural control in response to altered sensory conditions in persons with dysvascular and traumatic transtibial amputation. Arch Phys Med Rehabil. 2015 Feb;96(2):331-9. doi: 10.1016/j.apmr.2014.09.037. Epub 2014 Oct 22.
citation: Castro MP, Soares D, Mendes E, Machado L. Plantar pressures and ground reaction forces during walking of individuals with unilateral transfemoral amputation. PM R. 2014 Aug;6(8):698-707.e1. doi: 10.1016/j.pmrj.2014.01.019. Epub 2014 Jan 29.
citation: Marks RM, Long JT, Exten EL. Gait abnormality following amputation in diabetic patients. Foot Ankle Clin. 2010 Sep;15(3):501-7. doi: 10.1016/j.fcl.2010.05.001.
citation: Nolan L, Wit A, Dudzinski K, Lees A, Lake M, Wychowanski M. Adjustments in gait symmetry with walking speed in trans-femoral and trans-tibial amputees. Gait Posture. 2003 Apr;17(2):142-51. doi: 10.1016/s0966-6362(02)00066-8.