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).
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
- Recruiting
Istanbul Medıpol University
Istanbul
Medipol University
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.
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower
- 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 group | Role | What they receive |
|---|---|---|
| Lower extremity unilateral amputee | Other | Unilateral 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.
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)
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
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
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
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
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
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
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.
- First posted5 Mar 2024
- Study start15 Feb 2024
- Primary completion15 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Tanis, Medipol University
- Investigators
- GİZEM BOZTAŞ ELVERİŞLİ, Study director, Medipol University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functionality of Unilateral Lower Extremity Amputees Grouped According to the Medicare Functional K Classification System-Single Blind Study
- ClinicalTrials.gov ID
- NCT06293443
- Acronym / sponsor ID
- IMU-OP-TT-01
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower extremity unilateral amputee | Other | Other: Lower extremity unilateral amputeeUnilateral 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral lower extremity amputation,
- Being using a prosthesis,
- Being literate,
- Being between the ages of 18-65,
- Having a healthy stump,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower extremity unilateral amputeeTo 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. | Other | Lower extremity unilateral amputee |
Primary outcome
Amputee Mobility Scale
Time frame: 2 weeks
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.
7 secondary outcomes
One Leg Standing Test
Time frame: 2 weeks
Houghton Scale
Time frame: 2 weeks
8-Shape Walking Test
Time frame: 2 weeks
joint range of motion
Time frame: 2 weeks
proprioception
Time frame: 2 weeks
l test
Time frame: 2 weeks
10 Meter Walking Test
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GİZEM BOZTAŞ ELVERİŞLİ study director
Medipol University
1 site in 1 country: see every site and its status.
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.