Walking Characteristics of Patients With Amputation

Not yet recruiting

• Conditions: Amputation

• Registration Number: NCT05595291
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-10-22
• Study First Submitted QC: 2022-10-22
• Study First Posted: 2022-10-26
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-19
• Study Start: 2023-02-05
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-minute walking test	through study completion, an average of one month	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.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	through study completion, an average of one month	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)).
Locomotor capacity index	through study completion, an average of one month	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).