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Completed

NCT Number: NCT04330274

Comparison of Different Amputation Levels

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.

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Key information

Conditions

Amputee Balance Plantar Pressure Distrubution

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bipedal with open eyes

Other

Standing bipedal with open eyes on force platform

Bipedal with closed eyes

Other

Standing bipedal with closed eyes on force platform

Bipedal with open eyes and with platform

Other

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

Bipedal with closed eyes and with platform

Other

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

Primary outcomes

  1. Measurement of plantar pressure distrubution

    Time frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.

    Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with open eyes

  2. Measurement of plantar pressure distrubution

    Time frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.

    Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with platform under heel

  3. Determination of center of pressure

    Time frame: Change from baseline center of pressure at second 10, second 20 and second 30.

    Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with open eyes

  4. Determination of center of pressure

    Time frame: Change from baseline center of pressure at second 10, second 20 and second 30.

    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.

  5. Measurement of plantar pressure distrubution

    Time frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.

    Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with closed eyes

  6. Measurement of plantar pressure distrubution

    Time frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.

    Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel

  7. Determination of center of pressure

    Time frame: Change from baseline center of pressure at second 10, second 20 and second 30.

    Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with closed eyes

  8. Determination of center of pressure

    Time frame: Change from baseline center of pressure at second 10, second 20 and second 30.

    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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2020
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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