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Comparison of Transtibial and Transfemoral Amputees' Posture Parameters

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Completed
CT.gov ID
NCT04456244
Collaborator
Istanbul Saglik Bilimleri University (Other)
29
Enrollment
1
Location
27
Actual Duration (Days)
32.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

With the onset of prosthesis use following lower extremity amputations, body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. The aim of this study is to determine the static postural adaptations that appear at different amputation levels.

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of the static posture

Study Design

Study Type:
Observational
Actual Enrollment :
29 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Comparison of Transtibial and Transfemoral Amputees' Posture Parameters
Actual Study Start Date :
Jan 3, 2021
Actual Primary Completion Date :
Jan 23, 2021
Actual Study Completion Date :
Jan 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Group 1:Transtibial Amputation

Photographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis.

Other: Evaluation of the static posture
Photographing from the back, front and side with ADIBAS posturography in standing position
Group 2:Transfemoral Amputation

Photographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis.

Other: Evaluation of the static posture
Photographing from the back, front and side with ADIBAS posturography in standing position

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the static posture-1 [Changes from baseline static posture adaptations before and following Six Minutes Walking Test]

    Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in free standing position

  2. Evaluation of the static posture-2 [Changes from baseline static posture adaptations before and following Six Minutes Walking Test]

    Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in equal weighting on platform (3D L.A.S.A.R. Posture, 743L500, Ottobock)

  3. Evaluation of the back pain [Changes from baseline static posture adaptations before and following Six Minutes Walking Test]

    Pain will be evaluated by using Visual Analog Scale ranging 0(no pain)-10(worst pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Being between the ages of 18-65

  • Having had an amputation at least 6 months ago

  • Have had transfemoral amputation or transtibial amputation

  • To be able to perform ambulation independently

Exclusion Criteria:

  • mental inability to understand commands

  • have a neurological, orthopedic and systemic problem that will negatively affect posture or gait.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Saglık Bilimleri University Istanbul Turkey

Sponsors and Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
  • Istanbul Saglik Bilimleri University

Investigators

  • Principal Investigator: Nilüfer Kablan, PhD, Istanbul Sağlık Bilimleri Üniversitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT04456244
Other Study ID Numbers:
  • 19/164
First Posted:
Jul 2, 2020
Last Update Posted:
Jan 20, 2022
Last Verified:
Jun 1, 2020
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 Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
amputation, postural adaptations, transtibial, transfemoral
Additional relevant MeSH terms:
Amputation, Traumatic

Study Results

No Results Posted as of Jan 20, 2022