Clinical trial NCT06773559: Comparison of Transfemoral Amputees in Different Prosthesis Use Periods
Official title: Comparison of Posture, Balance, Gait and Plantar Pressure Parameters of Transfemoral Amputees in Different Prosthesis Use Periods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfemoral Amputees
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
First posted: 2025-01-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteer transfemoral amputees and healthy adults

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


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

Primary outcomes:
measure: Plantar pressure analysis
timeFrame: Baseline
measure: Gait analysis
timeFrame: Baseline
Secondary outcomes:
measure: Trunk posture analysis
timeFrame: Baseline
measure: Fear of falling
timeFrame: Baseline
measure: Body image
timeFrame: Baseline
measure: Satisfaction level
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Lokman Hekim University
state: Sogutozu
Study officials:
References: