Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03825432 |
| Other study ID # |
ETK00-2018-0068 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 20, 2019 |
| Est. completion date |
July 16, 2019 |
Study information
| Verified date |
October 2021 |
| Source |
Eastern Mediterranean University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
