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

Amputation, Traumatic Clinical Trial

Official title:

The Evaluation of the Relationship Between Thicknesses and Isokinetic Strength of Hip Flexor and Extensor Muscles in Patients With Unilateral Traumatic Transfemoral Amputation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827744
• Other study ID #: 36
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: October 2023
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: Merve Örücü Atar, MD
• Phone: 03122912443
• Email: drmerveorucu[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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. This study will be useful in understanding whether ultrasonography is an appropriate imaging method in the follow-up of changes in functional strength in the hip girdle in patients with unilateral traumatic transfemoral amputation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Amputation, Traumatic

Intervention

Other:
• Isokinetic evaluations
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
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.

Locations

Country	Name	City	State
Turkey	Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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