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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04330274
Other study ID # 09.2019.357
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date July 1, 2020

Study information

Verified date April 2019
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date July 1, 2020
Est. primary completion date February 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bipedal with open eyes
Standing bipedal with open eyes on force platform
Bipedal with closed eyes
Standing bipedal with closed eyes on force platform
Bipedal with open eyes and with platform
Standing bipedal with open eyes and with platform under heel of prosthetic foot on force platform
Bipedal with closed eyes and with platform
Standing bipedal with closed eyes and with platform under heel of prosthetic foot on force platform

Locations

Country Name City State
Turkey Marmara University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Nolan L, Wit A, Dudziñski K, Lees A, Lake M, Wychowañski M. Adjustments in gait symmetry with walking speed in trans-femoral and trans-tibial amputees. Gait Posture. 2003 Apr;17(2):142-51. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of plantar pressure distrubution Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with open eyes Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Primary Measurement of plantar pressure distrubution Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with platform under heel Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Primary Determination of center of pressure Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with open eyes Change from baseline center of pressure at second 10, second 20 and second 30.
Primary Determination of center of pressure Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with platform under heel. Change from baseline center of pressure at second 10, second 20 and second 30.
Primary Measurement of plantar pressure distrubution Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with closed eyes Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Primary Measurement of plantar pressure distrubution Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Primary Determination of center of pressure Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with closed eyes Change from baseline center of pressure at second 10, second 20 and second 30.
Primary Determination of center of pressure Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel. Change from baseline center of pressure at second 10, second 20 and second 30.
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