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AmputeeNCT03825432

Investigation of Physical Activity and Associated Factors in Lower Extremity Amputees

An observational study of Amputee, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Amputee
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Feb 2019to 16 Jul 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Lower Limb Amputees

Who may be able to join

  • Use prosthesis for at least 6 months
  • 18 years to 85 years old subjects
  • Independent walking distance of 30 meters
  • Individuals with unilateral amputation will be included

Who cannot join

  • Bilateral amputees

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Eastern Mediterranean University

    Mersin, 33010

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed 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.

Conditions
Amputee
Keywords
Physical activity, Prosthesis
Medical subject headings
Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical activity

    Physical activity of the subjects will be recorded by an accelerometer (Research Tracker 6, Version 3.1, Stay Healthy, Inc., Monrovia, USA) in kilocalories.

    Measured: 3 days

Secondary outcomes (9)
  1. 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. Shorter time means better mobility function.

    Measured: The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 5 minutes.

  2. 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 time will be recorded in seconds that shorter time means better mobility function.

    Measured: The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 5 minutes.

  3. 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 that higher distance means better balance.

    Measured: The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.

  4. 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. Longer distance means better ambulation capacity.

    Measured: The test will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.

  5. Activities-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% 'no trust' 'and 100% 100' completely sure ''. The higher score means better balance confidence.

    Measured: The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.

  6. Amputee 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. The higher score indicates worse body image.

    Measured: The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 2 minutes.

  7. Trinity Amputation and Prosthesis Experience Scale, Psychosocial adjustment subscale

    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.

    Measured: The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.

  8. Trinity Amputation and Prosthesis Experience Scale, Activity restriction subscale

    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.

    Measured: The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.

  9. Trinity Amputation and Prosthesis Experience Scale, Prosthesis satisfaction subscale

    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.

    Measured: The scale will be performed in the first day of assessment of each amputee for once after enrollment. It takes about 3 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2019
  2. Study start20 Feb 2019
  3. Primary completion16 Jul 2019
  4. Study completion16 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03825432
Sponsor's protocol ID
ETK00-2018-0068
Status last verified
Oct 2021
First submitted
24 Jan 2019
Last updated
14 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Amputee, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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