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Completed

NCT Number: NCT07203235

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Yıldırım Beyazıt University, Department of Physiotherapy and Rehabilitation

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(for Amputee Group):

  • 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

Inclusion criteria

(for Control Group):

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

Exclusion criteria

(for Amputee Group):

  • 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)

Exclusion criteria

(for Control Group):

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Knee Joint Position Sense (Proprioception)

    Time frame: Single assessment at time of participant enrollment

    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.

Secondary outcomes

  1. Trunk Position Sense (Proprioception)

    Time frame: Single assessment at time of participant enrollment

    Position sense of the trunk will be measured using a dual digital inclinometer (ACUMAR™, Lafayette, USA). Tests are conducted barefoot on a firm surface with eyes closed. Participants are instructed and trained before testing. For trunk position sense, inclinometers are placed on T1 and S1 spinous processes, and participants perform 30-degree trunk flexion movements and then return to neutral, attempting to replicate the angle three times.

  2. Core Muscle Function

    Time frame: Single assessment at time of participant enrollment

    Core muscle function will be assessed by measuring transversus abdominis (TrA) muscle strength using the Stabilizer Pressure Biofeedback Unit (Chattanooga Group Inc, USA). Participants lie prone with pressure set at 70 mmHg and perform the abdominal drawing-in maneuver three times for 10 seconds each; the average pressure change is recorded.

  3. Core Muscle Endurance (Trunk Flexor)

    Time frame: Single assessment at time of participant enrollment

    Core muscle endurance will be evaluated through McGill's endurance tests including trunk flexor, trunk extensor, and lateral plank tests. The trunk flexor test involves maintaining a 55-degree flexion position until the participant can no longer hold it. For all tests, participants will be asked to maintain the position for as long as possible, and the duration will be recorded.

  4. Core Muscle Endurance (Trunk Extansor)

    Time frame: Single assessment at time of participant enrollment

    Core muscle endurance will be evaluated through McGill's endurance tests including trunk flexor, trunk extensor, and lateral plank tests. The trunk extensor test is performed prone with pelvis, hips, and knees stabilized; participants hold a horizontal position until failure. For all tests, participants will be asked to maintain the position for as long as possible, and the duration will be recorded.

  5. Core Muscle Endurance (Lateral Plank)

    Time frame: Single assessment at time of participant enrollment

    Core muscle endurance will be evaluated through McGill's endurance tests including trunk flexor, trunk extensor, and lateral plank tests. The lateral plank test requires participants to maintain a side-lying plank position with the body aligned until loss of form or contact with the ground. For all tests, participants will be asked to maintain the position for as long as possible, and the duration will be recorded.

  6. Balance

    Time frame: Single assessment at time of participant enrollment

    Static balance will be evaluated using the single-leg stance test. Participants are asked to stand unsupported on one leg while maintaining balance. The duration they can hold this position is measured with a stopwatch and recorded in seconds

  7. Gait Speed

    Time frame: Single assessment at time of participant enrollment

    Gait speed will be assessed using the 10-meter walk test. Participants start from a standing position and walk 10 meters at their comfortable walking speed. The time to complete the 10 meters is measured with a stopwatch.

Sponsors and collaborators

Lead sponsor

sevilay seda bas

Other

Registry information

Official study title

Investigations of The Relationship Between Core Function Aand Endurance, Gait Speed, Balance, and Proprioception in Transtibial Amputees

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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