Walking Characteristics of Patients With Amputation

Amputation Clinical Trial

Official title:

Walking Characteristics of Patients With Amputation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05595291
• Other study ID #: 29
• Status: Not yet recruiting
• Start date: February 5, 2023
• Est. completion date: February 15, 2023

Study information

• Verified date: January 2023
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: Yasin Demir, MD
• Phone: +903122911806
• Email: yasin.demir3[@]saglik.gov.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. Secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

Description:

It is important to investigate the long-term changes in walking characteristics of patients with amputation and the factors affecting walking characteristics in these patients regarding prosthesis rehabilitation.

The main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. Secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 65

• Presence of lower extremity amputation

Exclusion Criteria:

• Conditions that prevent the use of prosthesis (wound, pain, etc.)

• Having a history of rheumatic disease

• Having cardiac pathology

• Having pulmonary pathology

• Having a situation that prevents communication

• Not giving written consent

Related Conditions & MeSH terms

• Amputation

Intervention

Other:
• investigation of the factors affecting walking characteristics
In order to investigate the factors affecting walking characteristics, 2-minute walking test, 10-point VAS (overall prosthesis satisfaction level, socket comfort and satisfaction level, knee joint satisfaction level, prosthetic foot satisfaction level, pain level in amputated extremity) and locomotor capacity index will be applied.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-minute walking test	Walking distance will be evaluated using the two-minute walking test (2MWT). Patients will be instructed to walk quickly, safely, and as much distance as possible along a rectangular path.	through study completion, an average of one month
Secondary	Visual Analog Scale	All patients will mark the severity of amputated extremity pain on a Visual Analog Scale (VAS; from 0 (no pain) to 10 (worst pain)). The socket system comfort and satisfaction, knee joint satisfaction, prosthetic foot satisfaction and overall prosthesis satisfaction will be evaluated with a 10-point VAS (from 0 (absolutely dissatisfied) to 10 (absolutely satisfied)).	through study completion, an average of one month
Secondary	Locomotor capacity index	The Locomotor Capabilities Index (LCI) is a validated measure of lower-limb amputees' ability to perform activities with prosthesis. The total LCI score is the sum of the item scores and can range from 0 (worst) to 30 (best).	through study completion, an average of one month