Comparison of Different Amputation Levels

Balance Clinical Trial

Official title:

Comparison of Different Amputation Levels in Terms of Balance Parameters and Plantar Pressure Distribution; Lower Extremity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330274
• Other study ID #: 09.2019.357
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Amputee
• Balance
• Plantar Pressure Distrubution

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.