AmputationNCT05999539
Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees
An observational study of Amputation and Fall, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial summary
Researchers aim to compare demographic characteristics, prosthesis type, functional capacity, and quality of life between faller and non-faller transtibial amputees. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Fall, Ambulation Difficulty
- What is being tested?
- Transtibial prosthesis
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2023to 15 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be the transtibial prosthetic users recorded in outpatient clinics working on amputee rehabilitation.
Who may be able to join
- Having the ability to walk at least 30-meter independently
- Using the transtibial prosthesis for at least one year.
Who cannot join
- Multiple limb amputees or prosthetic users
- Having prosthetic discomfort or stump ulcer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eastern Mediterranean University
Mersin, 33010
About this study
Official title: Comparison of Demography, Functional Capacity, Prosthesis Type and Health-related Quality of Life Between Faller and Non-faller Transtibial Amputees
Researchers aim to compare demographic characteristics, prosthesis type, functional capacity, and quality of life between faller and non-faller transtibial amputees.
Read the detailed description
Unilateral transtibial level prosthetic users will be included in this study. After getting the fall history of subjects, those who feel at least one time or more in the last year will be accepted as the faller group. Demographic characteristics, functional capacity, health-related quality of life, and prosthetic types used by amputees will be assessed. The main differences between the faller and non-faller transtibial amputees will be analyzed with the data.
- Conditions
- Amputation, Fall, Ambulation Difficulty, Quality of Life, Prosthesis User
- Being tested
- Transtibial prosthesis
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtibial prosthesisDevice
A transtibial prosthesis to be used for at least one year.
| Study group | Role | What they receive |
|---|---|---|
| Faller transtibial prosthetic users | Transtibial prosthetic users who fell at least once in the last year. Receives: Device: Transtibial prosthesis | |
| Non-faller transtibial prosthetic users | Transtibial prosthetic users who have no fall history. Receives: Device: Transtibial prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-minute walk test
The test to be carried out to find out functional capacity, in a 30-meter-long area will be marked at 3-meter intervals, and the turning points will be determined with an object such as a traffic cone. We will ask the individual to walk the maximum distance in 2 minutes and we will tell them that they can slow down and stop when they get tired. When 2 minutes are completed with a stopwatch, we will ask the individual to stop and record the walking distance in meters.
Measured: 1 week
Secondary outcomes (3)
Functional Reach Test
This test will be used to assess balance. The subjects will be asked to stand sideways next to the wall and wait with the shoulder in 90 degrees flexion, elbow in extension and fist closed without touching the wall with the arm close to the wall. The 3rd metacarpal head will be marked and the patient will be asked to reach as far as they can without taking a step, then the new location of the 3rd metacarpal head will be marked. Scoring will be determined by measuring the difference between the start and end position in centimeters. 3 attempts will be made and the best result will be taken.
Measured: 1 week
Timed Up and Go Test
This test will be used to assess fall risk. A distance of 3 meters will be determined in front of the chair, the individual is asked to get up from the chair and walk the determined distance, and the time elapsed will be recorded with a stopwatch with seconds.
Measured: 1 week
Trinity Amputation and Prosthesis Experiences Scales
This test is used to assess different aspects of amputees' experience of prosthesis use and quality of life. It gives a total score that means better when higher.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start25 Aug 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin YURT, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999539
- Sponsor's protocol ID
- ETK00-2023-0130
- Status last verified
- Dec 2023
- First submitted
- 12 Aug 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data of participants will not be shared individually because of health policy. Results will be shared as an overall data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Demography, Functional Capacity, Prosthesis Type and Health-related Quality of Life Between Faller and Non-faller Transtibial Amputees
- ClinicalTrials.gov ID
- NCT05999539
- Acronym / sponsor ID
- ETK00-2023-0130
- Conditions
- Amputation, Fall, Ambulation Difficulty, Quality of Life, Prosthesis User
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 21 Aug 2023 (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.
Researchers aim to compare demographic characteristics, prosthesis type, functional capacity, and quality of life between faller and non-faller transtibial amputees.
Detailed description
Unilateral transtibial level prosthetic users will be included in this study. After getting the fall history of subjects, those who feel at least one time or more in the last year will be accepted as the faller group. Demographic characteristics, functional capacity, health-related quality of life, and prosthetic types used by amputees will be assessed. The main differences between the faller and non-faller transtibial amputees will be analyzed with the data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faller transtibial prosthetic users | – | Device: Transtibial prosthesisTranstibial prosthetic users who fell at least once in the last year. |
| Non-faller transtibial prosthetic users | – | Device: Transtibial prosthesisTranstibial prosthetic users who have no fall history. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be the transtibial prosthetic users recorded in outpatient clinics working on amputee rehabilitation.
Key inclusion criteria (2 listed)
- Having the ability to walk at least 30-meter independently
- Using the transtibial prosthesis for at least one year.
Key exclusion criteria (2 listed)
- Multiple limb amputees or prosthetic users
- Having prosthetic discomfort or stump ulcer
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 |
|---|---|---|
| Transtibial prosthesisA transtibial prosthesis to be used for at least one year. | Device | Faller transtibial prosthetic users, Non-faller transtibial prosthetic users |
Primary outcome
Two-minute walk test
Time frame: 1 week
The test to be carried out to find out functional capacity, in a 30-meter-long area will be marked at 3-meter intervals, and the turning points will be determined with an object such as a traffic cone. We will ask the individual to walk the maximum distance in 2 minutes and we will tell them that they can slow down and stop when they get tired. When 2 minutes are completed with a stopwatch, we will ask the individual to stop and record the walking distance in meters.
3 secondary outcomes
Functional Reach Test
Time frame: 1 week
Timed Up and Go Test
Time frame: 1 week
Trinity Amputation and Prosthesis Experiences Scales
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No. Data of participants will not be shared individually because of health policy. Results will be shared as an overall data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Fall, 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 2 inclusion and 2 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 26 Dec 2023. 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?
Two-minute walk test (time frame: 1 week). 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 26 Dec 2023.