Evaluating the functionality of unilateral lower limb amputees
Evaluation of Functionality of Unilateral Lower Extremity Amputees Grouped According to the Medicare Functional K Classification System-Single Blind Study
NA · Medipol University · NCT06293443
This study is testing how well people with one leg amputated can move and function using different physical tests to see if their abilities can be measured more clearly.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medipol University (other) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06293443 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the functionality of individuals with unilateral lower extremity amputations using the Medicare Functional K Classification System. It seeks to transform subjective evaluations into objective measurements through various tests, including one-leg standing, ten-meter walking, and joint range of motion assessments. The study will involve 20 participants who meet specific inclusion criteria and will be conducted at Medicom Orthosis Prosthesis Center and Ortoport Prosthesis Application Center. Data will be analyzed using statistical methods to determine functional levels among the participants.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18-65 with unilateral lower extremity amputations who use a prosthesis and have a healthy stump.
Not a fit: Patients with bilateral amputations, upper extremity amputations, or significant cognitive, sensory, or orthopedic issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a standardized method for evaluating the functionality of amputees, leading to improved rehabilitation strategies.
How similar studies have performed: While similar studies have explored functionality in amputees, this approach aims to create a more objective evaluation method, making it a novel contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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, 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,
Where this trial is running
Istanbul
- Istanbul Medıpol University — Istanbul, Turkey (RECRUITING)
Study contacts
- Study coordinator: TUĞBA TANIŞ
- Email: tugbatnss@gmail.com
- Phone: +905379238206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amputation, Traumatic, Leg, Lower