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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05595291
Other study ID # 29
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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