Core Muscle Function and Postural Control in Lower Extremity Amputees

NCT07875075 | Recruiting

• 1 other identifier: FTREK25/164
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to determine the effect of amputation on core muscle groups by comparing core muscle thickness in individuals with lower extremity amputation to both their intact side and a healthy control group using ultrasonographic assessment. The secondary aim is to investigate the relationship between core muscle thickness and postural stability outcomes during different activities in individuals with lower extremity amputation, and to determine the effect of core muscles on postural control.

Conditions

Amputation; Ultrasonography; Postural Control; Balance; Core Muscles; Stiffness

Keywords

amputation; ultrasonography; balance; limits of stability; stiffness

Outcome Measures

Primary Outcomes (3)

• Diaphragm Thickening Fraction

  Diaphragm thickness will be assessed bilaterally at the zone of apposition using B-mode ultrasonography at the end of quiet expiration and during deep inspiration. Diaphragm thickening fraction will be calculated as \[(thickness during deep inspiration - thickness at the end of quiet expiration) / thickness at the end of quiet expiration\] × 100 and reported as a percentage (%). Three high-quality measurements will be obtained for each side, and the mean value will be used for analysis. Bilateral measurements will be used for side and group comparisons.

  Day 1

• Transversus Abdominis Activation Ratio

  Transversus abdominis muscle thickness will be assessed bilaterally using B-mode ultrasonography at the end of quiet expiration at rest and during the abdominal drawing-in maneuver. The activation ratio will be calculated by dividing muscle thickness during the abdominal drawing-in maneuver by muscle thickness at rest. Three high-quality measurements will be obtained for each side, and the mean value will be used for analysis. The activation ratio is dimensionless. Bilateral measurements will be used for side and group comparisons.

  Day 1

• Internal Oblique Activation Ratio

  Internal oblique muscle thickness will be assessed bilaterally using B-mode ultrasonography at the end of quiet expiration at rest and during the abdominal drawing-in maneuver. The activation ratio will be calculated by dividing muscle thickness during the abdominal drawing-in maneuver by muscle thickness at rest. Three high-quality measurements will be obtained for each side, and the mean value will be used for analysis. The activation ratio is dimensionless. Bilateral measurements will be used for side and group comparisons.

  Day 1

Secondary Outcomes (16)

• Standing Postural Sway

  Day 1

• Percentage of Remaining Limb

  Day 1

• Prosthesis Awareness

  Day 1

• Fear of Falling

  Day 1

• Reaction Time During Limits of Stability Test

  Day 1

Study Arms (2)

1) Experimental Group: individual with amputation

Participants in the amputee group will include individuals aged 20-60 years with unilateral transtibial or transfemoral amputation, classified as K1-K3 functional level, who are able to stand without assistive devices and use their prosthesis for at least 4 hours per day. All participants must provide voluntary informed consent. Individuals will be excluded if they have severe phantom or residual limb pain (≥6 on the Numeric Rating Scale), bilateral lower extremity amputation, or a body mass index greater than 30.

Control Group: Healthy Subjects

The control group will consist of healthy individuals with demographic characteristics similar to the amputee group and without a regular exercise habit. Individuals will be excluded if they have central or peripheral vestibular disorders, lower extremity joint contractures, use medications affecting balance, or have a body mass index greater than 30.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Amputees who applied to our faculty for prosthesis construction and control, and healthy individuals from relatives of the researcher reached by snowball method will constitute the sample of the study.

You may qualify if:

• Being between 20-60 years of age
• Having a unilateral transtibial or transfemoral amputation
• Being at K1-K3 functional activity level
• Being able to stand without the use of assistive devices
• Using a prosthesis for at least 4 hours per day
• Volunteering to participate in the study

You may not qualify if:

• Having phantom or residual limb pain ≥6 according to the Numeric Rating Scale
• Having bilateral lower extremity amputation
• Having a Body Mass Index greater than 30
• For the Healthy Control Group
• Healthy individuals with demographic characteristics similar to the amputee group
• Not having a regular exercise habit
• Having central or peripheral vestibular disorders
• Having lower extremity joint contractures
• Using medications that affect balance
• Having a Body Mass Index greater than 30

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Dokuz Eylül University Faculty of Physical Therapy and Rehabilitation 15 July Health Campus, Mithatpaşa Street No: 56/15 İnciraltı 35340 - İZMİR

Balçova, İzmir, 35130, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Seher Özyürek, Prof.

CONTACT

0 232 4124935; seherozyurek@gmail.com

Study Design

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

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 15, 2026
• Study Start: December 4, 2025
• Primary Completion (Estimated): July 4, 2027
• Study Completion (Estimated): December 4, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

TU (1)