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Clinical Trials/NCT05827744
NCT05827744
Recruiting
Not Applicable

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

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital1 site in 1 country27 target enrollmentMay 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amputation, Traumatic
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Enrollment
27
Locations
1
Primary Endpoint
10-meter walking test
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 15, 2023
End Date
December 15, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yasin Demir

Associate professor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

10-meter walking test

Time Frame: through study completion, an average of one month

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.

Timed up and go test

Time Frame: through study completion, an average of one month

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.

6-minute walking test (6MWT)

Time Frame: through study completion, an average of one month

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.

Study Sites (1)

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