The Relationship Between Thicknesses and Isokinetic Strength of Hip Flexor and Extensor Muscles

NCT05827744 | Unknown

• 1 other identifier: 36
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.

Conditions

Amputation, Traumatic

Keywords

amputation; hip flexors; hip extensors

Outcome Measures

Primary Outcomes (3)

• 6-minute walking test (6MWT)

  Functional performance will be assessed by 6MWT (in meter). Patients will be instructed to walk quickly, safely, and as much distance as possible over a rectangular path.

  through study completion, an average of one month

• 10-meter walking test

  The short-distance over-ground gait speed will be assessed using a 10-Meter Walk Test. Participants will be asked to walk at normal pace on a 10-meter walkway.

  through study completion, an average of one month

• Timed up and go test

  Timed up and go test will be used for quantifying functional mobility balance. Participants will be instructed to sit in a comfortable position on a 45-65 cm high steady chair with a backrest and armrest, with both arms resting on their thighs, and then quickly stand up and move towards and around a fixed cone 3 m away, return, and sit again.

  through study completion, an average of one month

Interventions

Isokinetic evaluations OTHER

Peak torque and total amount of work of hip flexors and extensors will be determined by the Cybex 6000 model computer-aided isokinetic system.

Ultrasonographic evaluations OTHER

Ultrasonographic evaluations will be performed with a 5-12 MHz linear probe (Logic e portable; GE Healthcare, China). The thicknesses of the hip flexor (psoas major) and extensor (gluteus maximus) muscles will be measured while the patient is in the prone position, in accordance with the literature.

Eligibility Criteria

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

Study Population

A total of 27 patients with unilateral transfemoral amputation

You may qualify if:

• Aged between 18-65
• The time elapsed after amputation \> 6 months
• Using prosthesis for at least 3 months
• Being able to walk without an assistive device

You may not qualify if:

• Bilateral lower extremity amputation
• Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Merve Örücü Atar

  assistant professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Örücü Atar, MD

CONTACT

03122912443; drmerveorucu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 25, 2023
• Study Start: May 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

TU (1)