Walking Characteristics of Patients With Amputation

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05595291

Collaborator

(none)

100

Enrollment

Anticipated Duration (Days)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amputation	Other: investigation of the factors affecting walking characteristics

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Walking Characteristics of Patients With Amputation

Anticipated Study Start Date :

Feb 5, 2023

Anticipated Primary Completion Date :

Feb 15, 2023

Anticipated Study Completion Date :

Feb 15, 2023

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

Principal Investigator: Yasin Demir, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yasin Demir, Associate Professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT05595291

Other Study ID Numbers:

First Posted:

Oct 26, 2022

Last Update Posted:

Jan 19, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yasin Demir, Associate Professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study Results

No Results Posted as of Jan 19, 2023