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Clinical Trials/NCT06773559
NCT06773559
Completed
N/A

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

Lokman Hekim Üniversitesi1 site in 1 country24 target enrollmentApril 5, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Transfemoral Amputees
Sponsor
Lokman Hekim Üniversitesi
Enrollment
24
Locations
1
Primary Endpoint
Plantar pressure analysis
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
April 5, 2024
End Date
November 8, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Lokman Hekim Üniversitesi
Responsible Party
Principal Investigator
Principal Investigator

Mustafa Sarı

Research Assistant

Lokman Hekim Üniversitesi

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
  • Having lower extremity contracture

Outcomes

Primary Outcomes

Plantar pressure analysis

Time Frame: Baseline

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.

Gait analysis

Time Frame: Baseline

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.

Secondary Outcomes

  • Trunk posture analysis(Baseline)
  • Fear of falling(Baseline)
  • Body image(Baseline)
  • Satisfaction level(Baseline)

Study Sites (1)

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