NCT04330274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 25, 2022

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

March 25, 2020

Last Update Submit

January 19, 2022

Conditions

AmputeePlantar Pressure DistrubutionBalance

Keywords

amputee,plantar pressure, balance

Outcome Measures

Primary Outcomes (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

Group 1

Unilateral transtibial amputee

Other: Bipedal with open eyesOther: Bipedal with closed eyesOther: Bipedal with open eyes and with platformOther: Bipedal with closed eyes and with platform

Group 2

Unilateral transfemoral amputee

Other: Bipedal with open eyesOther: Bipedal with closed eyesOther: Bipedal with open eyes and with platformOther: Bipedal with closed eyes and with platform

Interventions

Bipedal with open eyesOTHER

Standing bipedal with open eyes on force platform

Group 1Group 2
Bipedal with closed eyesOTHER

Standing bipedal with closed eyes on force platform

Group 1Group 2
Bipedal with open eyes and with platformOTHER

Standing bipedal with open eyes and with platform under heel of prosthetic foot on force platform

Group 1Group 2
Bipedal with closed eyes and with platformOTHER

Standing bipedal with closed eyes and with platform under heel of prosthetic foot on force platform

Group 1Group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Unilateral transtibial and transfemoral amputees

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 25450125BACKGROUND

  • 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.

    PMID: 24487128BACKGROUND

  • 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.

    PMID: 20682420BACKGROUND

  • 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.

    PMID: 12633775BACKGROUND

Study Officials

  • yasar tatar

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2020

First Posted

April 1, 2020

Study Start

October 1, 2019

Primary Completion

February 10, 2020

Study Completion

July 1, 2020

Last Updated

January 25, 2022

Record last verified: 2019-04

Locations

TU(1)