Comparison of Transfemoral Amputees in Different Prosthesis Use Periods

NCT ID: NCT06773559

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-05
• Study Completion Date: 2024-11-08

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Transfemoral amputee group using prosthesis for at least 3 years

plantar pressure, gait and static balance analysis

Intervention Type: DIAGNOSTIC_TEST

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

trunk posture analysis

Intervention Type: DIAGNOSTIC_TEST

Trunk posture analysis was performed using Diers Formetric 4D.

New transfemoral amputee group using prosthesis between two and six weeks

plantar pressure, gait and static balance analysis

Intervention Type: DIAGNOSTIC_TEST

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

trunk posture analysis

Intervention Type: DIAGNOSTIC_TEST

Trunk posture analysis was performed using Diers Formetric 4D.

Healthy adult group

plantar pressure, gait and static balance analysis

Intervention Type: DIAGNOSTIC_TEST

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

trunk posture analysis

Intervention Type: DIAGNOSTIC_TEST

Trunk posture analysis was performed using Diers Formetric 4D.

Interventions

plantar pressure, gait and static balance analysis

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

Intervention Type: DIAGNOSTIC_TEST

trunk posture analysis

Trunk posture analysis was performed using Diers Formetric 4D.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lokman Hekim University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mustafa Sarı

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lokman Hekim University

Ankara, Sogutozu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023187

Identifier Type: -

Identifier Source: org_study_id