<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03825432</url>
  </required_header>
  <id_info>
    <org_study_id>ETK00-2018-0068</org_study_id>
    <nct_id>NCT03825432</nct_id>
  </id_info>
  <brief_title>Investigation of Physical Activity and Associated Factors in Lower Extremity Amputees</brief_title>
  <official_title>Investigation of Physical Activity and Associated Factors in Lower Extremity Amputees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Mediterranean University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eastern Mediterranean University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate the physical activity and related factors of&#xD;
      individuals with lower extremity amputation.&#xD;
&#xD;
      Participants in the study who have signed a voluntary consent form will be informed about the&#xD;
      study first.Then, demographic information form will be started to be recorded in order to&#xD;
      inform the socio-demographic characteristics of the participants and the information about&#xD;
      amputation and prosthesis. The participants will be given the Timed Up and Go Test, L Test,&#xD;
      Functional Reach Test and 2 Minute Walk Test. Following these tests, participants will&#xD;
      continue with the scales to be answered by the participants themselves.These are&#xD;
      respectively; Activity-Specific Balance Confidence Scale, Trinity Amputation and Prosthesis&#xD;
      Experience Scale and Amputee Body Image Scale.Before the data is collected, individuals will&#xD;
      be informed about the equipment to be used in the tests.An adequate number of trials will be&#xD;
      conducted before the evaluation and use of the equipment in order to be familiar with the&#xD;
      equipment. All assessments will be made by the same physiotherapist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Amputation affects the quality of life of the individual; It is an important surgical&#xD;
      intervention that can lead to functional, psychological and social isolation. The prevalence&#xD;
      and incidence of amputation is difficult to determine precisely at the international&#xD;
      level.The etiology of amputation varies depending on geographical location.Peripheral&#xD;
      vascular diseases are the most common causes of amputation in developed countries and trauma&#xD;
      in developing countries.Limitations in body composition and function after amputation&#xD;
      decrease the activity level, so the participation of amputees is negatively affected.Physical&#xD;
      activity refers to any activity involving body movement and increasing the heart rate and&#xD;
      respiratory rate of the individual.&#xD;
&#xD;
      Most of the lower extremity amputated patients had low levels of physical activity and&#xD;
      participation in sports activities; It was also found that individuals with lower extremity&#xD;
      amputations were less active than those without lower extremity amputation.However, there are&#xD;
      few studies that have shown that individuals with lower extremity amputation are regularly&#xD;
      active, and the amputation of amputated individuals in these studies has mostly caused&#xD;
      traumatic amputations.&#xD;
&#xD;
      Lower extremity amputation; Although there is significant evidence showing that the risk of&#xD;
      developing a number of chronic degenerative diseases such as cardiovascular disease,&#xD;
      diabetes, hypertension, obesity and osteoarthritis significantly increases, there are few&#xD;
      studies investigating and investigating physical activity after amputation.Despite these&#xD;
      investigations, relatively little is known about the components or models of physical&#xD;
      activity necessary to provide protection against chronic diseases and to improve metabolic&#xD;
      health in these specific population groups. Therefore, accurate measurement and estimation of&#xD;
      the level of physical activity and energy expenditure is critical in the prevention and&#xD;
      prevention of chronic diseases in individuals with lower extremity amputation.&#xD;
&#xD;
      A higher level of physical activity is associated with better perceived quality of life in&#xD;
      individuals with lower extremity amputation.Therefore, it is important to develop physical&#xD;
      activity in individuals with lower extremity amputations.&#xD;
&#xD;
      Although there are studies investigating the physical activity in individuals with lower&#xD;
      extremity amputation as a result of our literature review, no study has been found&#xD;
      investigating factors related to physical activity.&#xD;
&#xD;
      The aim of this study was to investigate the physical activity and related factors of&#xD;
      individuals with lower extremity amputation.&#xD;
&#xD;
      RESEARCH QUESTIONS&#xD;
&#xD;
      Question 1: What is the level of physical activity in individuals with lower extremity&#xD;
      amputation?&#xD;
&#xD;
      Question 2: What are the factors associated with the level of physical activity in amputees&#xD;
      of the lower extremity?&#xD;
&#xD;
      THE UNIVERSE AND THE SAMPLING OF RESEARCH&#xD;
&#xD;
      The individuals to be included in the study will be selected from voluntary amputees who&#xD;
      apply to the Prosthesis-Orthotics Biomechanics Unit of the Department of Physiotherapy and&#xD;
      Rehabilitation of the Eastern Mediterranean University Faculty of Health Sciences.&#xD;
&#xD;
      As the sample volume in the study was to be linear regression analysis by using G-Power&#xD;
      program, it was determined that the total determinant factor number would be 8 and 108 people&#xD;
      as alpha, 0.05, beta: 0.80 and effect size as 0.15.&#xD;
&#xD;
      METHOD OF RESEARCH&#xD;
&#xD;
      Participants in the study who have signed a voluntary consent form will be informed about the&#xD;
      study first.Then, demographic information form will be started to be recorded in order to&#xD;
      inform the socio-demographic characteristics of the participants and the information about&#xD;
      amputation and prosthesis.The participants will be given the Timed Up and Go Test, L Test,&#xD;
      Functional Reach Test and 2 Minute Walk Test. Following these tests, participants will&#xD;
      continue with the scales to be answered by the participants themselves.These are&#xD;
      respectively; Activity-Specific Balance Confidence Scale, Trinity Amputation and Prosthesis&#xD;
      Experience Scale and Amputee Body Image Scale.Before the data is collected, individuals will&#xD;
      be informed about the equipment to be used in the tests.An adequate number of trials will be&#xD;
      conducted before the evaluation and use of the equipment in order to be familiar with the&#xD;
      equipment. All assessments will be made by the same physiotherapist.&#xD;
&#xD;
      INCLUDING CRITERIA&#xD;
&#xD;
        -  Use prosthesis for at least 6 months&#xD;
&#xD;
        -  18 years to 85 years&#xD;
&#xD;
        -  Independent walking distance of 30 meters&#xD;
&#xD;
        -  Individuals with unilateral amputation will be included.&#xD;
&#xD;
      EVALUATIONS IN THE RESEARCH&#xD;
&#xD;
      In this study, age, gender, height, body weight, body mass index, educational status, marital&#xD;
      status, profession, socio-demographic characteristics of the dominant side, as well as the&#xD;
      history of amputation, cause of amputation, amputation side and level, stump shape, phantom&#xD;
      pain Factors related to amputation, such as phantom sensation, type of prosthesis and&#xD;
      duration of use will be recorded with the form prepared.&#xD;
&#xD;
      Timed Up and Go Test: Timed Up and Go Test will be used to measure the risk of functional&#xD;
      mobility and fall.The participant seated on the chair without clinging to his arms 3m from&#xD;
      the ground, 3m after walking without touching a place to return, the chair will be asked to&#xD;
      go back to the sitting position and the time will be recorded in seconds..&#xD;
&#xD;
      L Test: The L test will be used to assess functional mobility. In the L-shaped direction, the&#xD;
      participants will be carried out on the ground where the long edge of L is 7 meters and the&#xD;
      short edge will be 3 meters. At the beginning of the test, the participants will sit in a&#xD;
      chair without arms and stand up from the chair with the start command, complete the L shape&#xD;
      at the preferred speed and return to the chair without interruption. Thus, a total distance&#xD;
      of 20 meters will be completed at the end of the test. The completion time of the test will&#xD;
      be recorded.The intrarater reliability of the test was found to be 0.97 and the interrater&#xD;
      reliability was 0.96, and it was shown to have a very high validity.&#xD;
&#xD;
      Functional Reach Test: The Functional Reach Test will be done to evaluate the stability&#xD;
      limits and fall risks of individuals.For the test, individuals will be asked to stand upright&#xD;
      on their shoulders with their shoulders wide open.In this position, the acromion level of&#xD;
      individuals will be marked on the wall.Individuals will be asked to lift their arms forward&#xD;
      to the marked level and to reach forwards without moving their feet.The distance between the&#xD;
      start and end position will be measured and recorded in cm.The test will be repeated 3 times&#xD;
      and the measurements will be averaged.The test will be repeated if individuals touch the wall&#xD;
      or take steps during the test.&#xD;
&#xD;
      2-Minute Walk Test: 2 Minute Walk Test will be used to evaluate the functional capacity of&#xD;
      individuals.The patient will be seated in the chair at the 25-meter track where the test will&#xD;
      be done and the distance within 2 minutes will be measured in meters.Before and after the&#xD;
      test, the patient's pulse and oxygen saturation with pulse oximetry will be measured and&#xD;
      recorded using the Borg Scale.&#xD;
&#xD;
      Activity-Specific Balance Confidence Scale: In order to evaluate the reliability of the&#xD;
      balance, the Activity-Specific Balance Confidence Scale, which has been validated for Turkish&#xD;
      reliability and validity, will be used.There are 16 functional activities in the scale. Each&#xD;
      individual will have 16 different activities and the reliability will be evaluated&#xD;
      accordingly.Measurement results from 0% to 100% are given.0% ir 'no trust' 'and 100% 100'&#xD;
      completely sure ''.If this scale gives a score above 80%, then it is mentioned that the&#xD;
      balance is reliable.For internal consistency, the Cronbach's alpha value was 0.9649 for the&#xD;
      test and 0.9648 for the retest.&#xD;
&#xD;
      Trinity Amputation and Prosthesis Experience Scale: In order to evaluate the quality of life,&#xD;
      the Trinity Amputation and Prosthesis Experience Scale which is a validity and validity scale&#xD;
      in amputees will be used. Trinity Amputation and Prosthesis Experience Scale two consists of&#xD;
      parts.In the first part; psychosocial adjustment, activity restriction and prosthesis&#xD;
      satisfaction.In the second part; questions about how many hours the prosthesis is worn,&#xD;
      general health and physical capacity. For internal consistency, Cronbach's alpha value for&#xD;
      psychosocial adjustment; 0.862 for activity restriction; 0.894 and 0.915 for prosthetic&#xD;
      satisfaction.&#xD;
&#xD;
      Amputated Body Image Scale: The Amputee Body Image Scale, which has been validated for&#xD;
      Turkish validity and reliability, will be used to assess body image disorders in amputees.&#xD;
      This 20-item scale evaluates the situations that the amputee perceives and feels about the&#xD;
      body. The score obtained varies between 20-100. A high score indicates a poor body image. The&#xD;
      Cronbach alpha value was 0.939.&#xD;
&#xD;
      Assessment of Physical Activity: Sociodemographic data such as age, height, weight and gender&#xD;
      from subjects will be recorded on the accelerometer profile using Stay Healthy software&#xD;
      (Research Tracker 6, Version 3.1, Stay Healthy, Inc., Monrovia, USA). The data will be&#xD;
      collected in computer environment as total calorie and efficiency count (VM; X axis, Y axis,&#xD;
      Z axis).The total calories will be recorded in kilocalories, while the data count will be&#xD;
      recorded in terms of acceleration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">July 16, 2019</completion_date>
  <primary_completion_date type="Actual">July 16, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity</measure>
    <time_frame>3 days</time_frame>
    <description>Physical activity of the subjects will be recorded by an accelerometer (Research Tracker 6, Version 3.1, Stay Healthy, Inc., Monrovia, USA) in kilocalories.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go Test</measure>
    <time_frame>The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 5 minutes.</time_frame>
    <description>Timed Up and Go Test will be used to measure the risk of functional mobility and fall. The participant seated on the chair without clinging to his arms 3m from the ground, 3m after walking without touching a place to return, the chair will be asked to go back to the sitting position and the time will be recorded in seconds. Shorter time means better mobility function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>L Test</measure>
    <time_frame>The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 5 minutes.</time_frame>
    <description>The L test will be used to assess functional mobility. In the L-shaped direction, the participants will be carried out on the ground where the long edge of L is 7 meters and the short edge will be 3 meters. At the beginning of the test, the participants will sit in a chair without arms and stand up from the chair with the start command, complete the L shape at the preferred speed and return to the chair without interruption. Thus, a total distance of 20 meters will be completed at the end of the test. The time will be recorded in seconds that shorter time means better mobility function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Reach Test</measure>
    <time_frame>The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.</time_frame>
    <description>The Functional Reach Test will be done to evaluate the stability limits and fall risks of individuals. For the test, individuals will be asked to stand upright on their shoulders with their shoulders wide open. In this position, the acromion level of individuals will be marked on the wall. Individuals will be asked to lift their arms forward to the marked level and to reach forwards without moving their feet. The distance between the start and end position will be measured and recorded in cm that higher distance means better balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2 Minute Walk Test</measure>
    <time_frame>The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.</time_frame>
    <description>2 Minute Walk Test will be used to evaluate the functional capacity of individuals. The patient will be seated in the chair at the 25-meter track where the test will be done and the distance within 2 minutes will be measured in meters. Longer distance means better ambulation capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities-Specific Balance Confidence Scale</measure>
    <time_frame>The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.</time_frame>
    <description>In order to evaluate the reliability of the balance, the Activity-Specific Balance Confidence Scale, which has been validated for Turkish reliability and validity, will be used. There are 16 functional activities in the scale. Each individual will have 16 different activities and the reliability will be evaluated accordingly.Measurement results from 0% to 100% are given.0% 'no trust' 'and 100% 100' completely sure ''. The higher score means better balance confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amputee Body Image Scale</measure>
    <time_frame>The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.</time_frame>
    <description>The Amputee Body Image Scale, which has been validated for Turkish validity and reliability, will be used to assess body image disorders in amputees. This 20-item scale evaluates the situations that the amputee perceives and feels about the body. The score obtained varies between 20-100. The higher score indicates worse body image.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trinity Amputation and Prosthesis Experience Scale, Psychosocial adjustment subscale</measure>
    <time_frame>The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.</time_frame>
    <description>In order to evaluate psychosocial condition, psychosocial adjustment subscale of the Trinity Amputation and Prosthesis Experience Scale scores between 5-25 that higher means better psychosocial condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trinity Amputation and Prosthesis Experience Scale, Activity restriction subscale</measure>
    <time_frame>The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.</time_frame>
    <description>In order to evaluate activity restriction, activity restriction subscale of the Trinity Amputation and Prosthesis Experience Scale scores between 4-12 that higher means higher activity restriction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trinity Amputation and Prosthesis Experience Scale, Prosthesis satisfaction subscale</measure>
    <time_frame>The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.</time_frame>
    <description>In order to evaluate prosthesis satisfaction, prosthesis satisfaction subscale of the Trinity Amputation and Prosthesis Experience Scale scores between 10-50 that higher means better prosthetic satisfaction.</description>
  </secondary_outcome>
  <enrollment type="Actual">108</enrollment>
  <condition>Amputee</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Lower Limb Amputees&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Use prosthesis for at least 6 months&#xD;
&#xD;
          -  18 years to 85 years old subjects&#xD;
&#xD;
          -  Independent walking distance of 30 meters&#xD;
&#xD;
          -  Individuals with unilateral amputation will be included&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        • Bilateral amputees&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yasin YURT, Asst.Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Eastern Mediterranean University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eastern Mediterranean University</name>
      <address>
        <city>Mersin</city>
        <zip>33010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Prosthesis</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03825432
org study id: ETK00-2018-0068
nct id: NCT03825432
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the physical activity and related factors of
      individuals with lower extremity amputation.

      Participants in the study who have signed a voluntary consent form will be informed about the
      study first.Then, demographic information form will be started to be recorded in order to
      inform the socio-demographic characteristics of the participants and the information about
      amputation and prosthesis. The participants will be given the Timed Up and Go Test, L Test,
      Functional Reach Test and 2 Minute Walk Test. Following these tests, participants will
      continue with the scales to be answered by the participants themselves.These are
      respectively; Activity-Specific Balance Confidence Scale, Trinity Amputation and Prosthesis
      Experience Scale and Amputee Body Image Scale.Before the data is collected, individuals will
      be informed about the equipment to be used in the tests.An adequate number of trials will be
      conducted before the evaluation and use of the equipment in order to be familiar with the
      equipment. All assessments will be made by the same physiotherapist.
Amputation affects the quality of life of the individual; It is an important surgical
      intervention that can lead to functional, psychological and social isolation. The prevalence
      and incidence of amputation is difficult to determine precisely at the international
      level.The etiology of amputation varies depending on geographical location.Peripheral
      vascular diseases are the most common causes of amputation in developed countries and trauma
      in developing countries.Limitations in body composition and function after amputation
      decrease the activity level, so the participation of amputees is negatively affected.Physical
      activity refers to any activity involving body movement and increasing the heart rate and
      respiratory rate of the individual.

      Most of the lower extremity amputated patients had low levels of physical activity and
      participation in sports activities; It was also found that individuals with lower extremity
      amputations were less active than those without lower extremity amputation.However, there are
      few studies that have shown that individuals with lower extremity amputation are regularly
      active, and the amputation of amputated individuals in these studies has mostly caused
      traumatic amputations.

      Lower extremity amputation; Although there is significant evidence showing that the risk of
      developing a number of chronic degenerative diseases such as cardiovascular disease,
      diabetes, hypertension, obesity and osteoarthritis significantly increases, there are few
      studies investigating and investigating physical activity after amputation.Despite these
      investigations, relatively little is known about the components or models of physical
      activity necessary to provide protection against chronic diseases and to improve metabolic
      health in these specific population groups. Therefore, accurate measurement and estimation of
      the level of physical activity and energy expenditure is critical in the prevention and
      prevention of chronic diseases in individuals with lower extremity amputation.

      A higher level of physical activity is associated with better perceived quality of life in
      individuals with lower extremity amputation.Therefore, it is important to develop physical
      activity in individuals with lower extremity amputations.

      Although there are studies investigating the physical activity in individuals with lower
      extremity amputation as a result of our literature review, no study has been found
      investigating factors related to physical activity.

      The aim of this study was to investigate the physical activity and related factors of
      individuals with lower extremity amputation.

      RESEARCH QUESTIONS

      Question 1: What is the level of physical activity in individuals with lower extremity
      amputation?

      Question 2: What are the factors associated with the level of physical activity in amputees
      of the lower extremity?

      THE UNIVERSE AND THE SAMPLING OF RESEARCH

      The individuals to be included in the study will be selected from voluntary amputees who
      apply to the Prosthesis-Orthotics Biomechanics Unit of the Department of Physiotherapy and
      Rehabilitation of the Eastern Mediterranean University Faculty of Health Sciences.

      As the sample volume in the study was to be linear regression analysis by using G-Power
      program, it was determined that the total determinant factor number would be 8 and 108 people
      as alpha, 0.05, beta: 0.80 and effect size as 0.15.

      METHOD OF RESEARCH

      Participants in the study who have signed a voluntary consent form will be informed about the
      study first.Then, demographic information form will be started to be recorded in order to
      inform the socio-demographic characteristics of the participants and the information about
      amputation and prosthesis.The participants will be given the Timed Up and Go Test, L Test,
      Functional Reach Test and 2 Minute Walk Test. Following these tests, participants will
      continue with the scales to be answered by the participants themselves.These are
      respectively; Activity-Specific Balance Confidence Scale, Trinity Amputation and Prosthesis
      Experience Scale and Amputee Body Image Scale.Before the data is collected, individuals will
      be informed about the equipment to be used in the tests.An adequate number of trials will be
      conducted before the evaluation and use of the equipment in order to be familiar with the
      equipment. All assessments will be made by the same physiotherapist.

      INCLUDING CRITERIA

        -  Use prosthesis for at least 6 months

        -  18 years to 85 years

        -  Independent walking distance of 30 meters

        -  Individuals with unilateral amputation will be included.

      EVALUATIONS IN THE RESEARCH

      In this study, age, gender, height, body weight, body mass index, educational status, marital
      status, profession, socio-demographic characteristics of the dominant side, as well as the
      history of amputation, cause of amputation, amputation side and level, stump shape, phantom
      pain Factors related to amputation, such as phantom sensation, type of prosthesis and
      duration of use will be recorded with the form prepared.

      Timed Up and Go Test: Timed Up and Go Test will be used to measure the risk of functional
      mobility and fall.The participant seated on the chair without clinging to his arms 3m from
      the ground, 3m after walking without touching a place to return, the chair will be asked to
      go back to the sitting position and the time will be recorded in seconds..

      L Test: The L test will be used to assess functional mobility. In the L-shaped direction, the
      participants will be carried out on the ground where the long edge of L is 7 meters and the
      short edge will be 3 meters. At the beginning of the test, the participants will sit in a
      chair without arms and stand up from the chair with the start command, complete the L shape
      at the preferred speed and return to the chair without interruption. Thus, a total distance
      of 20 meters will be completed at the end of the test. The completion time of the test will
      be recorded.The intrarater reliability of the test was found to be 0.97 and the interrater
      reliability was 0.96, and it was shown to have a very high validity.

      Functional Reach Test: The Functional Reach Test will be done to evaluate the stability
      limits and fall risks of individuals.For the test, individuals will be asked to stand upright
      on their shoulders with their shoulders wide open.In this position, the acromion level of
      individuals will be marked on the wall.Individuals will be asked to lift their arms forward
      to the marked level and to reach forwards without moving their feet.The distance between the
      start and end position will be measured and recorded in cm.The test will be repeated 3 times
      and the measurements will be averaged.The test will be repeated if individuals touch the wall
      or take steps during the test.

      2-Minute Walk Test: 2 Minute Walk Test will be used to evaluate the functional capacity of
      individuals.The patient will be seated in the chair at the 25-meter track where the test will
      be done and the distance within 2 minutes will be measured in meters.Before and after the
      test, the patient's pulse and oxygen saturation with pulse oximetry will be measured and
      recorded using the Borg Scale.

      Activity-Specific Balance Confidence Scale: In order to evaluate the reliability of the
      balance, the Activity-Specific Balance Confidence Scale, which has been validated for Turkish
      reliability and validity, will be used.There are 16 functional activities in the scale. Each
      individual will have 16 different activities and the reliability will be evaluated
      accordingly.Measurement results from 0% to 100% are given.0% ir 'no trust' 'and 100% 100'
      completely sure ''.If this scale gives a score above 80%, then it is mentioned that the
      balance is reliable.For internal consistency, the Cronbach's alpha value was 0.9649 for the
      test and 0.9648 for the retest.

      Trinity Amputation and Prosthesis Experience Scale: In order to evaluate the quality of life,
      the Trinity Amputation and Prosthesis Experience Scale which is a validity and validity scale
      in amputees will be used. Trinity Amputation and Prosthesis Experience Scale two consists of
      parts.In the first part; psychosocial adjustment, activity restriction and prosthesis
      satisfaction.In the second part; questions about how many hours the prosthesis is worn,
      general health and physical capacity. For internal consistency, Cronbach's alpha value for
      psychosocial adjustment; 0.862 for activity restriction; 0.894 and 0.915 for prosthetic
      satisfaction.

      Amputated Body Image Scale: The Amputee Body Image Scale, which has been validated for
      Turkish validity and reliability, will be used to assess body image disorders in amputees.
      This 20-item scale evaluates the situations that the amputee perceives and feels about the
      body. The score obtained varies between 20-100. A high score indicates a poor body image. The
      Cronbach alpha value was 0.939.

      Assessment of Physical Activity: Sociodemographic data such as age, height, weight and gender
      from subjects will be recorded on the accelerometer profile using Stay Healthy software
      (Research Tracker 6, Version 3.1, Stay Healthy, Inc., Monrovia, USA). The data will be
      collected in computer environment as total calorie and efficiency count (VM; X axis, Y axis,
      Z axis).The total calories will be recorded in kilocalories, while the data count will be
      recorded in terms of acceleration.
observational model: Other
time perspective: Cross-Sectional
measure: Physical activity
time frame: 3 days
description: Physical activity of the subjects will be recorded by an accelerometer (Research Tracker 6, Version 3.1, Stay Healthy, Inc., Monrovia, USA) in kilocalories.
measure: Timed Up and Go Test
time frame: The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 5 minutes.
description: Timed Up and Go Test will be used to measure the risk of functional mobility and fall. The participant seated on the chair without clinging to his arms 3m from the ground, 3m after walking without touching a place to return, the chair will be asked to go back to the sitting position and the time will be recorded in seconds. Shorter time means better mobility function.
measure: L Test
time frame: The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 5 minutes.
description: The L test will be used to assess functional mobility. In the L-shaped direction, the participants will be carried out on the ground where the long edge of L is 7 meters and the short edge will be 3 meters. At the beginning of the test, the participants will sit in a chair without arms and stand up from the chair with the start command, complete the L shape at the preferred speed and return to the chair without interruption. Thus, a total distance of 20 meters will be completed at the end of the test. The time will be recorded in seconds that shorter time means better mobility function.
measure: Functional Reach Test
time frame: The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.
description: The Functional Reach Test will be done to evaluate the stability limits and fall risks of individuals. For the test, individuals will be asked to stand upright on their shoulders with their shoulders wide open. In this position, the acromion level of individuals will be marked on the wall. Individuals will be asked to lift their arms forward to the marked level and to reach forwards without moving their feet. The distance between the start and end position will be measured and recorded in cm that higher distance means better balance.
measure: 2 Minute Walk Test
time frame: The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.
description: 2 Minute Walk Test will be used to evaluate the functional capacity of individuals. The patient will be seated in the chair at the 25-meter track where the test will be done and the distance within 2 minutes will be measured in meters. Longer distance means better ambulation capacity.
measure: Activities-Specific Balance Confidence Scale
time frame: The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.
description: In order to evaluate the reliability of the balance, the Activity-Specific Balance Confidence Scale, which has been validated for Turkish reliability and validity, will be used. There are 16 functional activities in the scale. Each individual will have 16 different activities and the reliability will be evaluated accordingly.Measurement results from 0% to 100% are given.0% 'no trust' 'and 100% 100' completely sure ''. The higher score means better balance confidence.
measure: Amputee Body Image Scale
time frame: The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.
description: The Amputee Body Image Scale, which has been validated for Turkish validity and reliability, will be used to assess body image disorders in amputees. This 20-item scale evaluates the situations that the amputee perceives and feels about the body. The score obtained varies between 20-100. The higher score indicates worse body image.
measure: Trinity Amputation and Prosthesis Experience Scale, Psychosocial adjustment subscale
time frame: The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.
description: In order to evaluate psychosocial condition, psychosocial adjustment subscale of the Trinity Amputation and Prosthesis Experience Scale scores between 5-25 that higher means better psychosocial condition.
measure: Trinity Amputation and Prosthesis Experience Scale, Activity restriction subscale
time frame: The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.
description: In order to evaluate activity restriction, activity restriction subscale of the Trinity Amputation and Prosthesis Experience Scale scores between 4-12 that higher means higher activity restriction.
measure: Trinity Amputation and Prosthesis Experience Scale, Prosthesis satisfaction subscale
time frame: The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.
description: In order to evaluate prosthesis satisfaction, prosthesis satisfaction subscale of the Trinity Amputation and Prosthesis Experience Scale scores between 10-50 that higher means better prosthetic satisfaction.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yasin YURT, Asst.Prof.
role: Study Director
affiliation: Eastern Mediterranean University
facility: 
country: Turkey
responsible party type: Sponsor