Relationship Between Prosthesis Adaptation and Functional Mobility

February 13, 2025 updated by: Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06690
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People admitted to Ankara Bilkent City Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases
Earthquake survivor amputees

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at a single study visit during the 12-month study period.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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)
Assessed at a single study visit during the 12-month study period.
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
Assessed at a single study visit during the 12-month study period.
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.
Assessed at a single study visit during the 12-month study period.
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
Assessed at a single study visit during the 12-month study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2023

Primary Completion (Actual)

July 19, 2024

Study Completion (Actual)

July 19, 2024

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E2-23-4575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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