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

NCT07203235 | Completed

• 1 other identifier: 08/932
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Knee Joint Position Sense (Proprioception)

  Position sense of the knee joints in both amputated and intact limbs will be measured using a dual digital inclinometer (ACUMAR™, Lafayette, USA). Participants are instructed and trained before testing. The participant was asked to lie prone with the knee positioned at 40 degrees. After learning this angle, the participant was asked to reproduce the remembered angle independently. The difference between the target angle and the reproduced angle was recorded. This procedure was repeated three times.

  Single assessment at time of participant enrollment

Secondary Outcomes (7)

• Trunk Position Sense (Proprioception)

  Single assessment at time of participant enrollment

• Core Muscle Function

  Single assessment at time of participant enrollment

• Core Muscle Endurance (Trunk Flexor)

  Single assessment at time of participant enrollment

• Core Muscle Endurance (Trunk Extansor)

  Single assessment at time of participant enrollment

• Core Muscle Endurance (Lateral Plank)

  Single assessment at time of participant enrollment

Study Arms (2)

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.

Other: evaluation

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.

Other: evaluation

Interventions

evaluation 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.

Amputee Group; Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This cross-sectional study will be conducted at Ankara Yıldırım Beyazıt University and at private prosthetics and orthotics centers in Ankara, Turkey.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• sevilay seda bas: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University, Department of Physiotherapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: September 29, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

TU (1)