Comparison of Transfemoral Amputees in Different Prosthesis Use Periods

NCT06773559 | Completed

• 1 other identifier: 2023187
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transfemoral Amputees

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Trunk posture analysis

  Baseline

• Fear of falling

  Baseline

• Body image

  Baseline

• Satisfaction level

  Baseline

Study Arms (3)

Transfemoral amputee group using prosthesis for at least 3 years

Diagnostic Test: plantar pressure, gait and static balance analysis; Diagnostic Test: trunk posture analysis

New transfemoral amputee group using prosthesis between two and six weeks

Diagnostic Test: plantar pressure, gait and static balance analysis; Diagnostic Test: trunk posture analysis

Healthy adult group

Diagnostic Test: plantar pressure, gait and static balance analysis; Diagnostic Test: trunk posture analysis

Interventions

plantar pressure, gait and static balance analysis DIAGNOSTIC_TEST

Plantar pressure, gait and static balance analysis performed using Ultium Insole SmartLead insoles.

Healthy adult group; New transfemoral amputee group using prosthesis between two and six weeks; Transfemoral amputee group using prosthesis for at least 3 years

trunk posture analysis DIAGNOSTIC_TEST

Trunk posture analysis was performed using Diers Formetric 4D.

Healthy adult group; New transfemoral amputee group using prosthesis between two and six weeks; Transfemoral amputee group using prosthesis for at least 3 years

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Volunteer transfemoral amputees and healthy adults

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Lokman Hekim University

Ankara, Sogutozu, 06530, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Gait

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: January 14, 2025
• Study Start: April 5, 2024
• Primary Completion: July 18, 2024
• Study Completion: November 8, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

TU (1)