The Dynamic Postural Changes in Transtibial and Transfemoral Amputees

NCT05301270 | Completed

• 1 other identifier: GO 21/1105
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; EMG; Balance; Perturbation

Keywords

Transtibial amputee; Transfemoral amputee; EMG; Balance; Perturbation

Outcome Measures

Primary Outcomes (4)

• Muscle activations

  Evaluation of muscle activations of lower extremity and trunk muscles with sEMG

  Day 0

• Percent Maximum Voluntary İsometric Contraction (MVIC)

  In order to normalize the muscles whose activations will be evaluated as percent MVIC, MVIC values will be measured in muscle test positions, which are the positions where the muscles are most activated.

  Day 0

• Analysis with video recording

  Data obtained by video recording on individuals on a platform that can move in the sagittal plane will be obtained and analyzed with Dartfish software.

  Day 0

• Balance Assessment

  Dynamic balance assessment will be performed with the Bertec BalanceCheck Screener™ BP5050 20x20 inc device (Bertec BP5050 balance plate platform; Bertec, Corp., Columbus, OH, USA).

  Day 0

Study Arms (3)

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

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

Healthy Subjects

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

Diagnostic Test: EMG Evaluation

Interventions

EMG Evaluation DIAGNOSTIC_TEST

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.

Also known as: Balance Assessment, Analysis Method with Video Recording

Healthy Subjects; Transfemoral Amputees; Transtibial Amputees

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Individuals with amputation to be included in the study (study group); It will consist of individuals who agree to participate in the research with transtibial or transfemoral amputation followed at Hacettepe University Faculty of Physical Therapy and Rehabilitation, Prosthesis and Biomechanics Unit and Bilim Orthotics Prosthesis Application Center. The control group, on the other hand, will consist of volunteers from patients' relatives and employees at Hacettepe University Faculty of Physical Therapy and Rehabilitation and Bilim Orthotics Prosthesis Application Center, who are similar to the study group in terms of age and gender.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Study Officials

• Semra Topuz, Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: February 24, 2023
• Primary Completion: August 24, 2024
• Study Completion: August 24, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)