Skip to main content
OpenTrials
Completed

NCT Number: NCT06827119

Relationship Between Prosthesis Adaptation and Functional Mobility

This study investigates the relationships between locomotor skills, timed performance, gait parameters, balance, fear of falling, and prosthesis satisfaction in individuals who underwent amputation due to an earthquake. Conducted at Ankara Bilkent City Hospital, it included participants aged 18 years and older who were in the prosthetic rehabilitation phase and classified at or above the K1 functional level.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amputees / Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Çankaya, 06690, Turkey (Türkiye)

About this study

Lower limb amputation significantly affects an individual's mobility, balance, and overall quality of life. The impact is even more pronounced in individuals who have undergone amputation due to traumatic events such as earthquakes. Understanding the factors influencing locomotor performance, balance, and prosthesis satisfaction in this specific population is crucial for optimizing rehabilitation strategies and improving functional outcomes.

This study was conducted at Ankara Bilkent City Hospital and included participants aged 18 years and older, who were in the prosthetic rehabilitation phase and classified at or above the K1 functional level. Participants underwent a series of assessments related to gait, balance, locomotor skills, timed performance, and prosthesis satisfaction. Data were analyzed using correlation analyses, taking into account normality distribution.

The study contributes to the existing literature by highlighting the importance of comprehensive rehabilitation programs that address both physical and psychological aspects of prosthesis adaptation. Future research should focus on larger sample sizes, longer follow-up periods, and the influence of psychosocial factors and rehabilitation approaches on prosthesis satisfaction and functional outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being over 18 years old
  • Having a lower extremity amputation
  • Being in the prosthetic period
  • Being at K1 functional level or above
  • Agreeing to participate in the study voluntarily

Treatment and study plan

Primary outcomes

  1. K level clasification

    Time frame: Assessed at a single study visit during the 12-month study period.

    The K-level classification was developed by the Centers for Medicare and Medicaid Services (CMS) to determine the current and potential functional mobility levels of prosthetic users. This system rates individuals from K0 (no ability or potential for ambulation with a prosthesis) to K4 (able to use a prosthesis in high-level activities), and it is used as a standardized assessment tool in the prosthetic prescription and reimbursement processes.

Other outcomes

  1. Body Mass Index (BMI):

    Time frame: Assessed at a single study visit during the 12-month study period.

    A calculation based on weight and height to categorize individuals as underweight, normal weight, overweight, or obese.

  2. Joint Range of Motion (ROM):

    Time frame: Assessed at a single study visit during the 12-month study period.

    Measures the movement capability of a joint in degrees, assessing flexibility and any restrictions in motion.

  3. Manuel muscle test

    Time frame: Assessed at a single study visit during the 12-month study period.

    The manual muscle test (MMT) is a clinical method used to evaluate the strength of specific muscles or muscle groups. It involves applying resistance to a muscle's voluntary contraction and grading its performance based on strength and endurance.Typically scored on a 0-5 scale.

  4. Timed Up and Go Test (TUG)

    Time frame: Assessed at a single study visit during the 12-month study period.

    Evaluates functional mobility by measuring the time taken to stand up, walk 3 meters, turn, and return to the chair.

  5. 10-Meter Walk Test (10MWT)

    Time frame: Assessed at a single study visit during the 12-month study period.

    Assesses walking speed by timing a person walking a 10-meter distance.

  6. 2-Minute Walk Test (2MWT)

    Time frame: Assessed at a single study visit during the 12-month study period.

    Measures endurance by evaluating the distance walked in two minutes.

  7. Houghton Scale

    Time frame: Assessed at a single study visit during the 12-month study period.

    Evaluates prosthesis use and mobility in individuals with lower limb amputations.

  8. Locomotor Capabilities Index (LCI)

    Time frame: Assessed at a single study visit during the 12-month study period.

    A questionnaire that assesses functional mobility, especially in individuals with prosthetic limbs.

  9. Berg Balance Scale (BBS)

    Time frame: Assessed at a single study visit during the 12-month study period.

    A 14-item scale used to measure balance and risk of falling in individuals.

  10. Fear of Falling Visual Analog Scale

    Time frame: Assessed at a single study visit during the 12-month study period.

    A subjective measure of the fear of falling, rated on a 0-10 scale.

  11. Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)

    Time frame: Assessed at a single study visit during the 12-month study period.

    A questionnaire evaluating user satisfaction with assistive devices in terms of performance and service quality.

  12. Center of Mass (COM) Assessment

    Time frame: Assessed at a single study visit during the 12-month study period.

    Analyzes body balance and stability by tracking COM movements on a specialized platform.

  13. Cadence Measurement with Treadmill-Based Gait Analysis

    Time frame: Assessed at a single study visit during the 12-month study period.

    Uses treadmill equipment to assess cadence (number of steps per minute)

  14. Double Support Percentage Measurement with Treadmill-Based Gait Analysis

    Time frame: Assessed at a single study visit during the 12-month study period.

    Uses treadmill equipment to assess the percentage of time both feet are in contact with the ground during walking

  15. Stride Length Measurement with Treadmill-Based Gait Analysis

    Time frame: Assessed at a single study visit during the 12-month study period.

    Uses treadmill equipment to assess the length of a single stride during walking.

  16. Step Width Measurement with Treadmill-Based Gait Analysis

    Time frame: Assessed at a single study visit during the 12-month study period.

    Uses treadmill equipment to assess the distance between the heels of the feet during walking

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Investigation of the Relationship Between Lower Limb Prosthesis Usage Skills and Adaptation Level with Functional Mobility and Activities of Daily Living

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.