Walking Characteristics of Patients With Amputation

NCT05595291 | Unknown

• 1 other identifier: 29
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Amputation

Keywords

amputation; walking; satisfaction; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analog Scale

  through study completion, an average of one month

• Locomotor capacity index

  through study completion, an average of one month

Interventions

investigation of the factors affecting walking characteristics OTHER

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One hundred patients with lower extremity amputation will be participated in this cross-sectional study.

You may qualify if:

• Aged between 18 and 65
• Presence of lower extremity amputation

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

MeSH Terms

Conditions

Personal Satisfaction; Pain

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasin Demir

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasin Demir, MD

CONTACT

+903122911806; yasin.demir3@saglik.gov.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: October 26, 2022
• Study Start: February 5, 2023
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: January 19, 2023

Record last verified: 2023-01