Comparison of Transfemoral Amputees in Different Prosthesis Use Periods

Comparison of Posture, Balance, Gait and Plantar Pressure Parameters of Transfemoral Amputees in Different Prosthesis Use Periods

Nowadays, the use of prostheses is recognised as a critical rehabilitation tool for individuals who have experienced limb loss as a result of amputation in order to improve their quality of life and help them return to their activities of daily living. Prostheses offer the potential to help these individuals regain their mobility as well as optimise their physical function. Especially for unilateral transfemoral amputees, there are a number of physical challenges they face during prosthesis use. These challenges can manifest as posture, balance and weight transfer problems that prosthesis users face in their daily lives. Correcting trunk posture, increasing the ability to maintain static balance and optimising plantar load distribution are critical factors affecting the success of prosthesis use. These challenges faced by unilateral transfemoral amputees during prosthesis use are closely related to post-amputation biomechanical changes. These changes can often lead to problems with balance, gait and functionality during activities of daily living. There is no effective comparative study based on computerised analysis data on posture assessment, static balance and plantar pressure distribution of transfemoral amputees.The aim of this study was to investigate the effects of prosthesis use by comparing posture, balance, gait and plantar pressure parameters of unilateral transfemoral amputees at different prosthesis use periods

Study Overview

• Status: Completed
• Conditions: Transfemoral Amputees
• Intervention / Treatment: Diagnostic test: plantar pressure, gait and static balance analysis; Diagnostic test: trunk posture analysis

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Turkey
  • Sogutozu
    • Ankara, Sogutozu, Turkey, 06530
      • Lokman Hekim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Volunteer transfemoral amputees and healthy adults

Description

Inclusion Criteria:

• To be using unilateral hydraulic knee joint and carbon foot prosthesis.
• Being amputee at the transfemoral level
• Being new or using prosthesis for at least 3 years.
• Having undergone amputation due to trauma.
• To have completed prosthetic period rehabilitation.
• To be between the ages of 18-45

Exclusion Criteria:

• Having a wound-ulcer problem
• Having amputation due to diabetes, peripheral arterial disease, tumour or venous insufficiency
• Being diagnosed with any systemic or neurological disease
• Affected perception and cognition
• Body mass index above 30.
• Having lower extremity contracture

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transfemoral amputee group using prosthesis for at least 3 years	Diagnostic test: plantar pressure, gait and static balance analysis; Plantar pressure, gait and static balance analysis performed using Ultium Insole SmartLead insoles.; Diagnostic test: trunk posture analysis; Trunk posture analysis was performed using Diers Formetric 4D.
New transfemoral amputee group using prosthesis between two and six weeks	Diagnostic test: plantar pressure, gait and static balance analysis; Plantar pressure, gait and static balance analysis performed using Ultium Insole SmartLead insoles.; Diagnostic test: trunk posture analysis; Trunk posture analysis was performed using Diers Formetric 4D.
Healthy adult group	Diagnostic test: plantar pressure, gait and static balance analysis; Plantar pressure, gait and static balance analysis performed using Ultium Insole SmartLead insoles.; Diagnostic test: trunk posture analysis; Trunk posture analysis was performed using Diers Formetric 4D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plantar pressure analysis	It was evaluated using the insoles of the Ultium Insole SmartLead. This system is compatible with the Ultium EMG system and can be used in a portable laboratory environment. It is also capable of providing users with zoned and total normalised load-time curves. In addition, it provides users with data such as 3D pressure animations and pressure centre, enabling a more detailed analysis of load distribution. These features make load distribution analysis for clinical or research purposes more effective and user-friendly. It also provides the possibility to monitor relative load distribution during balancing and bilateral or unilateral exercise applications. Applications of this technology include static and dynamic load imbalance detection, and body sway analysis.	Baseline
Gait analysis	Duration-distance characteristics of gait were evaluated using Ultium Insole SmartLead insoles. This system is compatible with the Ultium EMG system and can be used in a portable laboratory environment. It enables contact detection and quantitative analysis in walking, running and other dynamic activities. Applications of this technology include gait analysis, and running analysis.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trunk posture analysis	Evaluated with the DIERS Formetric 4D Analysis System. The system offers the ability to perform fast and radiation-free static and dynamic (functional) optical measurements of the human spine. This system works without contact and can objectively analyse spinal posture, scoliosis and other spinal deformities with various clinical parameters.	Baseline
Fear of falling	It was assessed with the International Falls Efficacy Scale (FES-I): Fear of falling can reduce a person's quality of life and lead to a range of negative consequences, including psychological distress, increased medication use, activity limitations, decreased physical functioning, increased risk of falls, and the need for institutional care. The FES measures confidence in performing activities of daily living without falling. This scale has an excellent performance in terms of reliability and is correlated with balance and gait measures. It is also known for its ability to predict future falls and decline in functional capacity. The FES-I is a scale used to assess fear of falling and was developed as an international version of the Falls Efficacy Scale. The FES-I is used to assess individuals' fear of falling and their confidence in performing daily activities. The FES-I is frequently used by health professionals to determine fear of falling and to assess the need for intervention.	Baseline
Body image	It was evaluated with the Amputee Body Image Scale (ABIS). The scale is recognised as an important tool in the process of understanding and improving the body image of amputees. It was developed to assess the body experiences of amputees. The ABIS contains 20 items and measures the perceptions and feelings of the person about his/her body after amputation. During its development, important psychometric properties such as content validity, internal consistency and validity were found acceptable.	Baseline
Satisfaction level	It was evaluated with the Prosthesis Satisfaction Questionnaire. This questionnaire assesses the satisfaction of amputees with their prostheses. The questionnaire consists of 15 questions, and for each question, the participants tick one of the following options: 3: completely agree, 2: strongly agree, 1: disagree, 0: strongly disagree and receive the appropriate score. The total score ranges from 0 to 45, with higher scores indicating higher levels of satisfaction.	Baseline

Collaborators and Investigators

• Sponsor: Lokman Hekim Üniversitesi

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Actual): July 18, 2024
• Study Completion (Actual): November 8, 2024

Study Registration Dates

• First Submitted: November 9, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2023187

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No