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Relationship Between Prosthesis Adaptation and Functional Mobility

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06827119
Enrollment
18
Registered
2025-02-14
Start date
2023-07-19
Completion date
2024-07-19
Last updated
2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputees / Rehabilitation

Keywords

Earthquake, Amputees, Gait Analysis, Balance

Brief summary

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.

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.

Interventions

None listed

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
K level clasificationAssessed 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

MeasureTime frameDescription
Joint Range of Motion (ROM):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.
Manuel muscle testAssessed 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.
Timed Up and Go Test (TUG)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.
10-Meter Walk Test (10MWT)Assessed at a single study visit during the 12-month study period.Assesses walking speed by timing a person walking a 10-meter distance.
2-Minute Walk Test (2MWT)Assessed at a single study visit during the 12-month study period.Measures endurance by evaluating the distance walked in two minutes.
Houghton ScaleAssessed at a single study visit during the 12-month study period.Evaluates prosthesis use and mobility in individuals with lower limb amputations.
Locomotor Capabilities Index (LCI)Assessed at a single study visit during the 12-month study period.A questionnaire that assesses functional mobility, especially in individuals with prosthetic limbs.
Body Mass Index (BMI):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.
Fear of Falling Visual Analog ScaleAssessed 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.
Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)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.
Center of Mass (COM) AssessmentAssessed at a single study visit during the 12-month study period.Analyzes body balance and stability by tracking COM movements on a specialized platform.
Cadence Measurement with Treadmill-Based Gait AnalysisAssessed at a single study visit during the 12-month study period.Uses treadmill equipment to assess cadence (number of steps per minute)
Double Support Percentage Measurement with Treadmill-Based Gait AnalysisAssessed 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
Stride Length Measurement with Treadmill-Based Gait AnalysisAssessed at a single study visit during the 12-month study period.Uses treadmill equipment to assess the length of a single stride during walking.
Step Width Measurement with Treadmill-Based Gait AnalysisAssessed 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
Berg Balance Scale (BBS)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026