AzTrials
AzTrials

AmputationNCT06293443

Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System

A study testing Lower extremity unilateral amputee in people with Amputation and Amputation; Traumatic, Leg, Lower, run by Medipol University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Amputation, Amputation; Traumatic, Leg, Lower
What is being tested?
Lower extremity unilateral amputee
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2024to 1 Apr 2024
Phase
Interventional
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Unilateral lower extremity amputation,
  • Being using a prosthesis,
  • Being literate,
  • Being between the ages of 18-65,
  • Having a healthy stump,
  • Using your current prosthesis in daily living activities,

Who cannot join

  • Bilateral lower extremity amputation
  • Unilateral or bilateral amputation of the upper extremity,
  • Having a cognitive or mental problem,
  • Having serious hearing and vision problems,
  • The individual has an orthopedic disease other than amputation,
  • Having an uncontrolled neurological and systemic systemic disease,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul Medıpol University

    Istanbul

    Medipol University

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Functionality of Unilateral Lower Extremity Amputees Grouped According to the Medicare Functional K Classification System-Single Blind Study

The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests.

Read the detailed description

The study will be carried out at Medicom Orthosis Prosthesis Center and Ortoport Prosthesis Application Center. The study will be conducted in accordance with the principles of human experimentation as defined in the Declaration of Helsinki. For this purpose, amputees who will participate in the study will be given detailed information about the study and will have to sign an informed consent form. 20 unilateral lower extremity amputations will be taken. The inclusion and exclusion criteria of the study are as follows; Inclusion criteria;

Unilateral lower extremity amputation, Using a prosthesis, Being literate, Being between the ages of 18-65, Having a healthy stump, Using your current prosthesis in daily living activities,

Exclusion criteria; Bilateral lower extremity amputation, Unilateral or bilateral amputation of the upper extremity, Having a cognitive or mental problem, Having serious hearing and vision problems, The individual has an orthopedic disease other than amputation, Having an uncontrolled neurological and systemic systemic disease,

SPPS 25.0 (Statistical Package for the Social Sciences) statistical package program will be used to evaluate the data. When the differences between two groups are desired to be evaluated, "Student's t Test" is used if it meets the parametric test prerequisites; If not, the "Mann Whitney-U test" will be used.

Being tested
Lower extremity unilateral amputee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lower extremity unilateral amputeeOther

    To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, Ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, Houghton scale and joint position sense evaluation tests.

Study groups in NCT06293443
Study groupRoleWhat they receive
Lower extremity unilateral amputeeOtherUnilateral transtibial and unilateral transfemoral amputees were evaluated in the study. Criteria for autees to participate in the study; Being a unilateral lower extremity amputee, using a prosthesis, being literate, being between the ages of 18-65, having a healthy stump, and using their current prosthesis in daily life activities. Individuals who had knee disarticulation amputation and individuals who had hip disarticulation amputation were not included in the study.
Receives: Other: Lower extremity unilateral amputee

What is being measured

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

  1. Amputee Mobility Scale

    It is a 21-item scale that evaluates static and dynamic balance. It is also used to predict the amputee's potential ambulation level. It is also a scale used to evaluate function during or after rehabilitation. Questions include sitting balance, transfers, standing balance, walking, stairs, assistive device use. Scoring is made between 0-47.

    Measured: 2 weeks

Secondary outcomes (7)
  1. One Leg Standing Test

    This test measures balance and standing ability. It is done by keeping time. The patient is asked to stand on one leg with arms at either side of the body. The test is performed in two ways, with eyes open and closed. The patient is asked to lift one leg up while standing. If the patient is using an assistive device such as a cane, the time is recorded when the patient stops holding it, or when the patient lifts his foot up. The time is stopped when the patient's foot touches the ground. If a loss of balance occurs in less than 5 seconds, the test is terminated. If the patient can stand on one leg for 30 seconds, the test is said to be over. If the cut-off value is <10 seconds, there is a balance disorder; if it is <5 seconds, there is a risk of falling. The score in the test is related to age and as age increases, the score decreases.

    Measured: 2 weeks

  2. Houghton Scale

    It is a scale that objectively evaluates the level of independence of lower extremity amputees with their prostheses. The scale parallels the Medicare Functional K Classification System. A Houghton Scale score ≥ 9 corresponds to a level K3 or K4 amputee, Houghton Scale scores 6-8 correspond to a level K2 amputee, and a Houghton Scale score ≤ 5 corresponds to a level K1 amputee. The Houghton scale is a scale scored between 0-12.

    Measured: 2 weeks

  3. 8-Shape Walking Test

    It is one of the tests that measures speed and agility abilities together. It measures the daily walking ability of older adults with mobility impairments (8). 8ŞYT tests a participant's walking on both straight and curved paths. It uses a path in which the participant is asked to walk in a figure eight around two cones. Scores are recorded in two areas: speed (time to complete), amplitude (number of steps taken).

    Measured: 2 weeks

  4. joint range of motion

    The presence of limitation will be evaluated by checking the normal joint movements of the amputees, and whether there is an effect on the ROM values during the use of the prosthesis will be taken into account. Joint range of motion of amputees will be evaluated using the Goniometer-Pro smartphone application.

    Joint range of motion will be measured based on reference and pivot points in supine and prone positions. Measurements will be taken on both sides and noted. In unilateral transtibial amputee; Range of motion in knee joint flexion, extension, hip joint flexion, extension and trunk flexion, extension and lateral flexion will be checked. In unilateral transfemoral amputee; Hip joint flexion, extension and trunk flexion, extension, lateral flexion range of motion will be measured based on standing reference and pivot points. Measurements will be taken on both sides and noted.

    Measured: 2 weeks

  5. proprioception

    With this test, joint position sense, which is a component of proprioception, will be measured. Joint position sense is a person's ability to perceive the position sense of a joint and restore it when the position of the extremity is changed. The most well-known tests in the evaluation of proprioception measure the person's capacity to actively or passively perform a targeted joint position (active/passive repositioning test) or the threshold of perceiving the desired joint movement (movement detection threshold test).

    Measured: 2 weeks

  6. l test

    It is a performance-based measure that can be used to evaluate physical function, including dynamic balance ability. The test is a modification of the "Timed Up and Go" test. The L-test allows evaluation of walking over a longer walking distance and involves turning in two directions. Amputees have a 1-minute rest period between trials and a 2-minute rest period between measurements. Amputees are instructed to walk at comfortable walking speeds, with or without their usual walking aids. Before participation, a standard demonstration and explanation of both outcome measures is given. In order to perform the test; 1 stopwatch, 1 chair, 3 meters and 7 meters long walking area are required.

    Measured: 2 weeks

  7. 10 Meter Walking Test

    It is a test that evaluates the walking performance of an amputee. This test is a performance test used to evaluate walking speed over a short distance in meters per second. The equipment required for the test is a stopwatch and a ground with a specified distance. Total time for scoring is recorded in meters/second. An individual assistive device may be used, but must be kept consistent and documented for each test. Three trials are made and the average of these three trials is taken. Patients are asked to walk a distance of 10 meters in a straight line on a flat road, at their own pace, using assistive walking devices, if any.

    Measured: 2 weeks

Timeline

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

  1. First posted5 Mar 2024
  2. Study start15 Feb 2024
  3. Primary completion15 Mar 2024 (estimated)
  4. Study completion1 Apr 2024 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06293443
Sponsor's protocol ID
IMU-OP-TT-01
Status last verified
Feb 2024
First submitted
27 Feb 2024
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lower extremity unilateral amputee in people with Amputation and Amputation; Traumatic, Leg, Lower, run by Medipol 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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?

Results are not available in the source record.

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

Contact TUĞBA TANIŞ (+905379238206, tugbatnss@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amputee Mobility Scale (time frame: 2 weeks). 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 5 Mar 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in