The Investigations of Core Muscles, Gait, Balance and Proprioception in Transtibial Amputees

NCT ID: NCT07203235

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2025-11-30

Brief Summary

The goal of this observational study is to investigate the effects of transtibial amputation on core function and endurance, and their relationship with proprioception, balance, and gait in adults with transtibial amputation and healthy controls.

The main questions it aims to answer are:

Do individuals with transtibial amputation show reduced core function and endurance compared to non-amputees?

Is there a relationship between core function/endurance and proprioception, balance, and gait performance in transtibial amputees?

Researchers will compare individuals with transtibial amputation to non-amputee individuals to see if there are significant differences in core endurance, posture, and functional abilities.

Participants will:

Perform tests to assess core function and muscular endurance

Undergo evaluations of proprioception, balance, and gait

Conditions

Amputation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Amputee Group

This group consists of individuals aged between 18 and 50 years who have undergone a unilateral transtibial amputation and have been using a prosthesis for at least 6 months. Participants must have a Medicare Functional Classification Level (MFCL) of K2 or higher, indicating the ability to ambulate in the community. Individuals with neurological or mental disorders, recent (past 12 months) orthopedic problems other than amputation, pregnancy, or those who use walking aids will be excluded.

evaluation

Intervention Type: OTHER

Participants will undergo a series of evaluations including core muscle function tests, endurance assessments, proprioceptive measurements, balance testing, and gait analysis. These assessments are non-invasive and observational, aimed at comparing functional performance between individuals with transtibial amputation and healthy controls. No interventions will be applied; only assessments will be conducted.

Control Group

This group includes healthy individuals aged between 18 and 50 years with no history of amputation. Participants must not have any neurological or mental disorders, recent orthopedic issues (within the past 12 months), or pregnancy, and must not use walking aids.

evaluation

Intervention Type: OTHER

Participants will undergo a series of evaluations including core muscle function tests, endurance assessments, proprioceptive measurements, balance testing, and gait analysis. These assessments are non-invasive and observational, aimed at comparing functional performance between individuals with transtibial amputation and healthy controls. No interventions will be applied; only assessments will be conducted.

Interventions

evaluation

Participants will undergo a series of evaluations including core muscle function tests, endurance assessments, proprioceptive measurements, balance testing, and gait analysis. These assessments are non-invasive and observational, aimed at comparing functional performance between individuals with transtibial amputation and healthy controls. No interventions will be applied; only assessments will be conducted.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 50 years
• Unilateral transtibial amputation
• Use of a prosthesis for at least 6 months
• Medicare Functional Classification Level (MFCL) of K2 or higher (indicating the ability to ambulate in the community)
• Willingness to participate and provide informed consent

• Age between 18 and 50 years
• Willingness to participate and provide informed consent

Exclusion Criteria

• Presence of any neurological disorder
• Presence of any mental health disorder
• Any orthopedic condition (other than amputation) within the past 12 months
• Pregnancy
• Use of a walking aid (e.g., cane, walker)

• Presence of any neurological disorder
• Presence of any mental health disorder
• Any orthopedic condition within the past 12 months
• Pregnancy
• Use of a walking aid (e.g., cane, walker)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

sevilay seda bas

OTHER

Sponsor Role: lead

Responsible Party

sevilay seda bas

Asst. Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ankara Yıldırım Beyazıt University, Department of Physiotherapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

08/932

Identifier Type: -

Identifier Source: org_study_id