Comparison of Different Amputation Levels

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT04330274
Collaborator
(none)
85
1
9
9.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Bipedal with open eyes
  • Other: Bipedal with closed eyes
  • Other: Bipedal with open eyes and with platform
  • Other: Bipedal with closed eyes and with platform

Study Design

Study Type:
Observational
Actual Enrollment :
85 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Comparison of Different Amputation Levels in Terms of Balance Parameters and Plantar Pressure Distribution; Lower Extremity
Actual Study Start Date :
Oct 1, 2019
Actual Primary Completion Date :
Feb 10, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Group 1

Unilateral transtibial amputee

Other: Bipedal with open eyes
Standing bipedal with open eyes on force platform

Other: Bipedal with closed eyes
Standing bipedal with closed eyes on force platform

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

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

Group 2

Unilateral transfemoral amputee

Other: Bipedal with open eyes
Standing bipedal with open eyes on force platform

Other: Bipedal with closed eyes
Standing bipedal with closed eyes on force platform

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

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

Outcome Measures

Primary Outcome Measures

  1. Measurement of plantar pressure distrubution [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marmara University Istanbul Turkey 34000

Sponsors and Collaborators

  • Marmara University

Investigators

  • Study Director: yasar tatar, Marmara University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marmara University
ClinicalTrials.gov Identifier:
NCT04330274
Other Study ID Numbers:
  • 09.2019.357
First Posted:
Apr 1, 2020
Last Update Posted:
Jan 25, 2022
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marmara University

Study Results

No Results Posted as of Jan 25, 2022