Viewing Study NCT06046300



Ignite Creation Date: 2024-05-06 @ 7:31 PM
Last Modification Date: 2024-10-26 @ 3:08 PM
Study NCT ID: NCT06046300
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-10-06
First Post: 2023-09-14

Brief Title: The Relationship Between Trunk Position Sense and Muscle Activation Balance and Quality of Life in Amputees
Sponsor: Hacettepe University
Organization: Hacettepe University

Study Overview

Official Title: Investigation of the Relationship Between Trunk Position Sense and Muscle Activation Balance and Quality of Life in Individuals With Transtibial Amputation
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study was planned to examine the relationship between trunk position sense and muscle activation balance and quality of life in individuals with transtibial amputation Individuals with unilateral transtibial amputation who have been using prostheses for at least 1 year and volunteered to participate in the study as well as healthy individuals with similar demographic characteristics will be included in the study The number of cases considered to be included in the study will be obtained from the statistical analysis of the results of the pilot study to be conducted with 5 individuals since there is no study on the subject The power of the study will be determined as 080 After determining the number of individuals to be included in the study group a control group will be formed with the same number of healthy individuals The study will be terminated when the determined total number of participants is reached Body position sense trunk muscle activation static and dynamic balance performances and quality of life of all individuals will be evaluated Body position sense of individuals with Dualer IQ Pro Digital Inclinometer device trunk muscle activation with Delsys Trigno IM wireless surface electromyography sEMG system balance with Bertec balance platform balance and functional mobility with Berg Balance Scale BDI Timed Up and Go Test SKYT and Modified Star Excursion Test SEBT and quality of life will be evaluated with Trinity Amputation and Prosthesis Experience Scale TAPES As a result of our study investigators think that it will contribute to the current scientific knowledge about the somatosensory and biomechanical mechanisms underlying the abnormalities that occur in the trunk after transtibial amputation to determine whether the trunk position sense of individuals with transtibial amputation is affected or not and to determine the relationship between trunk position sense and muscle activation balance and quality of life
Detailed Description: Amputation is a major trauma that significantly disrupts the biomechanics of the musculoskeletal system results in serious physical and psychological losses and affects the quality of life social and professional life of the individual

Following lower extremity amputation somatosensory input muscle activity and joint mobility decrease in the amputated part of the extremity

The ability to maintain postural stability is one of the most important aspects of our daily lives

While standing the postural control system adjusts the center of pressure and gathers inputs from the visual vestibular and somatosensory systems ie proprioceptive and cutaneous senses to maintain the center of gravity on the base of support

The ability to maintain balance is severely impaired following lower extremity amputation

As the stump fails to compensate for the lack of foot and ankle as a proprioceptive organ the postural control system is reprogrammed and compensatory mechanisms are developed to prevent weight-bearing asymmetries somatosensory loss reduced support surface and increased joint stiffness

These changes are also reflected in changes in neuromuscular motor output such as postural sway during standing

Although used prostheses are an alternative to partially reduce deficiencies current prosthetic technologies do not provide enough sensory feedback

Persons with lower extremity amputations exhibit abnormal trunk movement during functional tasks than non-injured persons

As shown in studies an asymmetrical posture and balance problem occurs in individuals with amputation

The resulting asymmetry can be associated with chronic neuromuscular problems such as back and extremity pain vascular diseases and early arthritis

Controlled trunk movement is essential for balance and stability while walking Individuals with lower extremity amputations often exhibit abnormal trunk movement but the underlying mechanisms are not well understood

Lower extremity amputation results in loss of muscles tendons ligaments and joint capsule severely affecting the lower extremity and thus body function

These structures are not only essential for movement they also function as sensory receptors and when lost proprioception suffers

It includes conscious proprioception kinesthesia strength sense and joint position sense

Several studies have investigated changes in proprioception in individuals with transtibial amputation and have presented different results

Fontes et al concluded that asymmetric body weight distribution was not accompanied by a decrease in knee proprioception in transtibial amputees

Latanioti et al They stated that when joint position sense at 15 was evaluated stump proprioceptive knowledge was not significantly affected after knee amputation and prosthesis application and the loss of knee sensory receptors in these individuals was compensated by alternative mechanisms

Liao and Skinner concluded that there is a significant difference in knee joint proprioception between prosthetic and intact limbs in persons with below-knee amputation

Eakin et al They designed a proprioception measurement system to evaluate lower extremity knee joint proprioception in 10 above-knee amputees

The system allowed subjects to be tested in a position simulating the late swing phase of gait

The ability to repeat the lower extremity positions specified for the intact and prosthetic extremities of the subjects was recorded for the detection of slow passive movement

As a result of the study a significant difference was detected between the passive motion detection threshold of the amputated and intact extremities however they stated that there was no significant difference between passive motion reposition of amputated and intact extremities

This finding demonstrates the importance of hip joint motion appreciation when these motions are relevant in the proprioception of the prosthetic knee joint of amputees

However prosthetic limb passive motion positioning error decreases with age which may improve amputees ability to use the remaining lower extremity proprioceptive mechanisms to compensate for the loss of anatomical knee joint structures

There are many studies in the literature examining position sense muscle activity balance and quality of life in individuals with transtibial amputation

However studies have focused on the lower extremities Individuals with transtibial amputation often have abnormal trunk movement but the mechanisms underlying this abnormality in terms of trunk are not well understood

Information on trunk muscle activity and trunk position sense in individuals with transtibial amputation is very limited

In the current literature the trunk position sense of individuals with transtibial amputation and the relationship of trunk position sense with muscle activation balance and quality of life

Therefore in this study it is aimed to investigate whether the trunk position sense including the trunk right and left sides of the individuals with transtibial amputation is affected and the relationship between trunk position sense and muscle activation balance and quality of life

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None