NCT05301270

The Dynamic Postural Changes in Transtibial and Transfemoral Amputees

The Effect of Dynamic Postural Changes on Muscle Activation, Kinematic Parameters and Investigation of Balance Strategies in Transtibial and Transfemoral Amputees

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This research was planned to examine how unpredictable movements on the support surface will affect muscle activation and kinematic parameters in individuals with transtibial and transfemoral amputations. Individuals aged between 18-45 years, using prostheses for at least 1 year, able to stand and walk independently without a walking aid, and volunteered to participate in the study with unilateral transtibial and unilateral transfemoral amputation, and healthy individuals similar to these individuals in terms of age and gender will be included in the study.

Detailed description

This research was planned to examine how unpredictable movements on the support surface will affect muscle activation and kinematic parameters in individuals with transtibial and transfemoral amputations. Individuals aged between 18-45 years, using prostheses for at least 1 year, able to stand and walk independently without a walking aid, and volunteered to participate in the study with unilateral transtibial and unilateral transfemoral amputation, and healthy individuals similar to these individuals in terms of age and gender will be included in the study. The number of cases considered to be included in the study will be determined by the number of individuals required for the power of the study to be 0.80 in the interim statistical analysis to be made after including 5 individuals, since no similar studies on the subject could be found. After determining the number of individuals to be included in the study group, a control group consisting of the same number of healthy individuals will be formed. The amount of body weight on the intact leg and prosthetic limb of individuals with amputation "L.A.S.A.R." with the posture device, artificial limb (prosthesis) awareness will be evaluated with the "Forgotten Joint Score-12" scale. Posture assessment of all individuals will be carried out by photogrammetric method. Dynamic balance evaluations of all participants will be made with the "Bertec balance device". Afterwards, the compensatory postural responses of all individuals, which are formed by the movements of the platform in the sagittal plane at an unpredictable moment, while standing on the motor-assisted and controllable movable platform, will be evaluated. Muscle activations occurring in both lower extremity and trunk muscles during compensatory postural responses will be evaluated with the "Delsys Trigno IM wireless surface electromyography (sEMG) system". Simultaneously, the motion will be recorded with the camera from the sagittal plane and the "Dartfish Analysis Software" software will be used for the analysis of the video images obtained. By using video recording and analysis method, angular changes in the joints during body oscillations, segment positions and balance strategies used will be examined. As a result of our research, it is anticipated to determine whether there is a difference between transtibial, transfemoral amputation and healthy individuals in terms of balance strategies resulting from unexpected surface perturbations, muscle activations in the lower extremities and trunk, and kinematic changes. In addition, it is anticipated to determine whether there is a relationship between dynamic balance values and lower extremity and trunk muscle activations that occur with unexpected surface perturbations in transtibial amputated, transfemoral amputated and healthy individuals. Thus, it is thought that the biomechanical properties of compensatory postural responses, which are very important in terms of maintaining postural control in individuals with transtibial amputation and transfemoral amputation, will contribute to the current scientific knowledge.

Conditions

• Amputation
• EMG
• Balance
• Perturbation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	EMG Evaluation	Muscle activations in the lower extremity and trunk muscles during compensatory postural responses will be evaluated. The Delsys Trigno IM (Delsys Inc. Natick, Massachusetts, USA) wireless surface electromyography (EMG) system will be used to evaluate muscle activation. In the lower extremity; Muscle activations of tibialis anterior, gastrocnemius, quadriceps and hamstring muscle groups and erector spinae in the trunk will be evaluated. While the muscle groups above the stump on the amputated side of the individuals in the amputation group will be evaluated, all muscle groups specified on the healthy side will be evaluated. In the control group, all muscle groups on the dominant side, but on the non-dominant side, all other muscles except the tibialis anterior and gastrocnemius muscles will be evaluated in order to be compatible with the amputation group.

Timeline

• Start date: 2023-02-24
• Primary completion: 2024-08-24
• Completion: 2024-08-24
• First posted: 2022-03-29
• Last updated: 2025-09-15

Locations

1 site across 1 country: Turkey (Türkiye)