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

Sponsor
Mustafa Cem TÜRKMEN (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05301270
Collaborator
(none)
5
20

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: EMG Evaluation

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
5 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effect of Dynamic Postural Changes on Muscle Activation, Kinematic Parameters and Investigation of Balance Strategies in Transtibial and Transfemoral Amputees
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Transtibial Amputees

Individuals aged 18-45 years, with unilateral transtibial amputation, traumatic amputation cause, using prosthesis for at least 1 year, no skin lesions-open wound on the stump, no phantom sensation or pain, no musculoskeletal problems that may affect balance other than amputation will be included.

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.
Other Names:
  • Balance Assessment
  • Analysis Method with Video Recording
  • Transfemoral Amputees

    Individuals aged 18-45 years, with unilateral transfemoral amputation, traumatic amputation cause, using prosthesis for at least 1 year, no skin lesions-open wound on the stump, no phantom sensation or pain, no musculoskeletal problems that may affect balance other than amputation will be included.

    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.
    Other Names:
  • Balance Assessment
  • Analysis Method with Video Recording
  • Healthy Subjects

    Healthy individuals between the ages of 18-45 will be included.

    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.
    Other Names:
  • Balance Assessment
  • Analysis Method with Video Recording
  • Outcome Measures

    Primary Outcome Measures

    1. %Maximum Voluntary İsometric Contraction (MVIC) [%Maximum Voluntary İsometric Contraction (MVIC) measurements will take 60 minutes for each patient.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    For all groups;

    • After giving detailed information about the research, those who volunteered to participate in the research

    • Able to stand and walk independently without any walking aid

    • They are determined as individuals with cooperation who can understand tests and evaluations.

    For Amputation Groups;

    • Having unilateral transtibial or transfemoral amputation,

    • The cause of amputation is traumatic,

    • Functional classification is at the level of K2 and K3 (Medicare Functional Classification Level),

    • Using prosthesis for at least 1 year,

    • No skin lesion or open wound on the stump,

    • No phantom sensation or pain

    • It was determined as individuals who do not have musculoskeletal problems (muscle shortness, limitation of joint movement, etc.) that may affect balance other than amputation.

    Exclusion Criteria:

    For all groups;

    • Known orthopedic (except amputation for the amputee group), neurological disease, vestibular problems, severe visual impairment, cognitive dysfunction,

    • Having pain originating from the musculoskeletal system (Also for the amputation group; stump pain or the presence of pain caused by the use of prosthesis),

    • Individuals who exercise regularly,

    • With a history of serious trauma,

    • History of falling in the last 1 year,

    • Pain during measurement of maximal voluntary contraction,

    • It was determined as individuals with a body mass index (BMI)>30 kg/m².

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mustafa Cem TÜRKMEN

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mustafa Cem TÜRKMEN, PhD student, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT05301270
    Other Study ID Numbers:
    • GO 21/1105
    First Posted:
    Mar 29, 2022
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mustafa Cem TÜRKMEN, PhD student, Hacettepe University

    Study Results

    No Results Posted as of Apr 11, 2022